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GPI (USA)

Category: 2024

Granules unit in Andhra Pradesh gets U.S. FDA inspection report with NAI status

Granules India achieves SBTi approval for ambitious net-zero goals

Granules India Gets US FDA Nod For Tablets To Treat Major Depressive Disorder

Granules India Launches ‘Breast Health Express’ Mobile Unit For Cancer Screening

Granules India gets USFDA nod for generic Glycopyrrolate oral solution

USFDA gives nod to Granules India’s generic formulation to treat depression

Empowering Women, Driving Change: Priyanka Chigurupati On Leadership And Inclusivity In The Health Industry

Granules India announces ANDA approval for Colchicine Capsules, drug has annual US sales of $55 million

Granules API, formulations facility in Vizag completes U.S. FDA inspection

Granules India gets USFDA nod for generic pantoprazole sodium tablets

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Granules India is a vertically integrated, high-growth pharmaceutical product manufacturing company based in Hyderabad, India. We manufacture high-quality API, FD, PFI and Speciality Products with a focus on customer centricity.

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Eltrombopag Olamine

CAS Number: 496775-62-3

Description

Eltrombopag Olamine is the orally active ethanolamine salt of eltrombopag, a small-molecule, nonpeptide thrombopoietin receptor agonist.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Antihemorrhagics
Monograph Status	NA
Granules Product Status	Commercially Available
Regulatory Filing/Technical Package	US DMF
Innovator Brands	Promacta, Promacta Kit
Available dosage Form/Strength	Tablet (12.5/25/50/75/100 mg), For Suspension,Oral (EQ 12.5 Acid/Packet,EQ 25 Acid/Packet)

Atazanavir Sulfate

CAS Number: 229975-97-7

Description

Atazanavir is an aza-dipeptide analogue with a bis-aryl substituent on the (hydroxethyl)hydrazine moiety with activity against both wild type and mutant forms of HIV protease.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Antiretroviral
Monograph Status	NA
Granules Product Status	Commercially Available
Regulatory Filing/Technical Package	US DMF
Innovator Brands	Capsule, Powder
Available dosage Form/Strength	Capsule(EQ 100/150/200/300 Base)/Powder(EQ 50 Base/Packet)

Cetirizine Hydrochloride, USP

CAS Number: 83881-52-1

Description

Cetirizine Hydrochloride is a synthetic phenylmethyl-piperazinyl derivative, antihistaminic Cetirizine is a metabolite of hydroxyzine and a selective peripheral histamine H1-receptor antagonist.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Antihistamine
Monograph Status	A
Granules Product Status	Commercially Available
Regulatory Filing/Technical Package	US DMF
Innovator Brands	Zyrtec, Zyrtec allergy, Quzyttir
Available dosage Form/Strength	Capsule(5/10mg), Syrup(5mg/ml), Tablet ODT(10mg), Tablet(5/10mg), Solution/Drops(EQ 0.24% BASE), Solution Intravenous(10MG/ML (10MG/ML), Tablet, Chewable(2.5/5/10mg)

Bupropion Hydrochloride, USP

CAS Number: 31677-93-7

Description

Bupropion Hydrochloride is the hydrochloride salt of the aminoketone bupropion, with antidepressant activity.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Antidepressant
Monograph Status	A
Granules Product Status	Commercially Available
Regulatory Filing/Technical Package	US DMF
Innovator Brands	Forfivo Xl/ Wellbutrin Sr/ Wellbutrin Xl/ Zyban/Wellbutrin
Available dosage Form/Strength	Tablet Extended Release(450/100/150/200/300/50mg), Tablet(50/75/100)

Fexofenadine Hydrochloride, USP

CAS Number: 138452-21-8

Description

Fexofenadine Hydrochloride is the hydrochloride salt form of fexofenadine, a carboxylated metabolic derivative of terfenadine and second generation, long-lasting selective histamine H1 receptor antagonist, with antihistaminic activity.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Antihistamine
Monograph Status	A
Granules Product Status	Commercially Available
Regulatory Filing/Technical Package	US DMF
Innovator Brands	Allegra
Available dosage Form/Strength	Suspension(30mg/ml) , Tablet(30/60/180mg), Capsule(60mg), Tablet ODT(30mg)

Fluconazole, USP

CAS Number: 86386-73-4

Description

Fluconazole is a synthetic triazole with antifungal activity. Fluconazole preferentially inhibits fungal cytochrome P-450 sterol C-14 alpha-demethylation, resulting in the accumulation of fungal 14 alpha-methyl sterols, the loss of normal fungal sterols, and fungistatic activity.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Antifungal
Monograph Status	USP-A, EP-A
Granules Product Status	Commercially Not Available
Regulatory Filing/Technical Package	US DMF, CEP
Innovator Brands	Diflucan
Available dosage Form/Strength	For Suspension(200mg/5ml, 50mg/5ml), Tablet(50/100/150/200mg), Injectable(200mg/100ml, 400mg/200ml)

Gabapentin, USP

CAS Number: 60142-96-3

Description

Gabapentin is a synthetic analogue of the neurotransmitter gamma-aminobutyric acid with anticonvulsant activity. Although its exact mechanism of action is unknown, gabapentin appears to inhibit excitatory neuron activity.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Anticonvulsant
Monograph Status	A
Granules Product Status	Commercially Not Available
Regulatory Filing/Technical Package	US DMF
Innovator Brands	Neurontin, Gralise
Available dosage Form/Strength	Tablet(100/300/400mg), Capsule(600/800mg), Solution(250mg/5ml)

Guaifenesin USP

CAS Number: 93-14-1

Description

Guaifenesin is a glyceryl guaiacolate with expectorant effects. Guaifenesin increases respiratory tract mucus secretions, acts as an irritant to gastric vagal receptors and recruits efferent parasympathetic reflexes that cause glandular exocytosis.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Expectorant
Monograph Status	A
Granules Product Status	Commercially Available
Regulatory Filing/Technical Package	US DMF
Innovator Brands	Mucinex
Available dosage Form/Strength	Tablet(600/1200mg)

Methocarbamol USP

CAS Number: 532-03-6

Description

Methocarbamol is a carbamate with centrally acting muscle relaxant properties. Though the exact mechanism of action of methocarbamol was not established, it's postulated to be via a mechanism similar of carbamate, inhibition of acetylcholinesterase at synapses in the autonomic nervous system, neuromuscular junction, and central nervous system.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Muscle relaxant
Monograph Status	USP-A, EP-NA
Granules Product Status	Commercially Available
Regulatory Filing/Technical Package	US DMF, ASMF
Innovator Brands	Robaxin
Available dosage Form/Strength	Tablet(500/750mg), Solution-IM,IV(1G/10ml)

Omeprazole Magnesium, USP

CAS Number: 95382-33-5

Description

Omeprazole Magnesium is the magnesium salt form of a benzimidazole with selective and irreversible proton pump inhibitor activity. In the acidic compartment of parietal cells, omeprazole is protonated and converted into the active achiral sulfenamide.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Anti-ulcerative
Monograph Status	A
Granules Product Status	Not Available - DMF filled
Regulatory Filing/Technical Package	US DMF
Innovator Brands	Prilosec, Prilosec OTC
Available dosage Form/Strength	Tablet Delayed Release(EQ 20mg base), For Suspension DR(EQ 2.5mg Base/Packet, EQ 10mg Base/Packet)

Pazopanib

CAS Number: 444731-52-6

Description

Pazopanib is a multiple kinase inhibitor that limits tumor growth by targeting angiogenesis via inhibition of enzymes including vascular endothelial growth factor receptor (VEGFR), platelet-derived growth factor receptor, useful for treating Renal cell carcinoma.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Anticancer
Monograph Status	IH
Granules Product Status	Commercially Available
Regulatory Filing/Technical Package	US DMF
Innovator Brands	Votrient
Available dosage Form/Strength	Tablet (200/400mg)

Melphalan Hcl

CAS Number: 148-82-3

Description

Amino acid-like antineoplastic agent and chemotherapy medication used to treat multiple myeloma, ovarian cancer, melanoma, and AL amyloidosis.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Anticancer
Monograph Status	IH
Granules Product Status	Commercially Available
Regulatory Filing/Technical Package	US DMF
Innovator Brands	Alkeran
Available dosage Form/Strength	Tablet (2mg); Injectable (EQ 50MG BASE/VIAL)

Prazosin Hydrochloride, USP

CAS Number: 19237-84-4

Description

Prazosin Hydrochloride is a synthetic piperazine derivative with hypotensive antiadrenergic properties, Prazosin Hydrochloride reduces peripheral resistance and relaxes vascular smooth muscles as a selective adrenergic alpha-1 antagonist by a mechanism not completely known.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Antihypertensive
Monograph Status	A
Granules Product Status	Not Available - DMF Filied
Regulatory Filing/Technical Package	US DMF
Innovator Brands	Minipress, Minipress XL
Available dosage Form/Strength	Capsule (1/2/5 mg), Tablet Extended Release (2.5/ 5mg)

Rifaximin

CAS Number: 80621-81-4

Description

Rifaximin is an orally administered, semi-synthetic, nonsystemic antibiotic derived from rifamycin SV with antibacterial activity. Rifaximin binds to the beta-subunit of bacterial DNA-dependent RNA polymerase, inhibiting bacterial RNA synthesis and bacterial cell growth.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Antibiotic
Monograph Status	NA
Granules Product Status	NA (Process validation under progress)
Regulatory Filing/Technical Package	US DMF
Innovator Brands	Xifaxan
Available dosage Form/Strength	Tablet (200/550mg)

Acetaminophen

CAS Number: 103-90-2

Description

Acetaminophen is a nonnarcotic analgesic and antipyretic drug.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Analgesic, Antipyretic
Monograph Status	USP-A, EP-A
Granules Product Status	Commercially Available
Regulatory Filing/Technical Package	US DMF, CEP
Innovator Brands	Acephen, Neopap, Tylenol, Ofirmev
Available dosage Form/Strength	Suppository,Rectal(80/120/325/650mg); Tablet, Extended Release (650mg); Solution,Intravenous (1gm/100ml; 500gm/50ml)

Bortezomib

CAS Number: 179324-69-7

Description

Bortezomib is a dipeptide Boronic acid derivative and proteasome inhibitor used to treat multiple myeloma and mantle cell lymphoma.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Oncology
Monograph Status	NA
Granules Product Status	Commercial Available
Regulatory Filing/Technical Package	US DMF
Innovator Brands	Velcade
Available dosage Form/Strength	Powder;Intravenous(3.5mg/ vial)

Dasatinib

CAS Number: 302962-49-8

Description

Dasatinib is a selective tyrosine kinase receptor inhibitor.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Oncology
Monograph Status	NA
Granules Product Status	Commercial Available
Regulatory Filing/Technical Package	US DMF
Innovator Brands	Sprycel
Available dosage Form/Strength	Tablet (20/50/70/80/100/140mg)

Dimethyl Fumarate

CAS Number: 624-49-7

Description

Dimethyl fumarate is an anti-inflammatory and role as an immunomodulator and an antipsoriatic. It is an enoate ester, a methyl ester and a diester.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Immuno modulatory agent
Monograph Status	NA
Granules Product Status	Commercial Available
Regulatory Filing/Technical Package	US DMF
Innovator Brands	Tecfidera
Available dosage Form/Strength	Capsule Delayed release (120/240 mg)

Levocetirizine Dihydrochloride USP

CAS Number: 130018-87-0

Description

Levocetirizine is an antihistamine used to relieve allergy symptoms.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Antihistamine
Monograph Status	USP-A, EP-NA
Granules Product Status	Commercial Available
Regulatory Filing/Technical Package	US DMF, ASMF
Innovator Brands	Xyzal
Available dosage Form/Strength	Tablet (5mg), Oral solution (2.5mg/ml)

Losartan Potassium USP

CAS Number: 124750-99-8

Description

Losartan potassium is an angiotensin II receptor blocker acting on the AT1 receptor subtype.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Antihypertensive
Monograph Status	USP-A, EP-A
Granules Product Status	Commercial Available
Regulatory Filing/Technical Package	US DMF, CEP
Innovator Brands	Cozaar
Available dosage Form/Strength	Tablet (25/50/100mg)

Metformin Hydrochloride USP

CAS Number: 1115-70-4

Description

Metformin is an anti-diabetic medication (biguanide). It works by lowering glucose production in the liver, delaying the absorption of sugar (glucose) from the intestines, and increasing the body's sensitivity to insulin.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Hypoglycemic
Monograph Status	USP-A, EP-A
Granules Product Status	Commercially Available
Regulatory Filing/Technical Package	US DMF, CEP
Innovator Brands	Glucophage, Glucophage XR, Glumetza, Fortamet
Available dosage Form/Strength	Tablet (500/625/750/850/1000mg), Tablet ER(500/750/1000 mg), solution (500mg/ml), For suspension ER (500mg/ml)

Metoprolol Succinate USP

CAS Number: 98418-47-4

Description

Metoprolol Succinate is the succinate salt form of metoprolol, a cardioselective competitive beta-1 adrenergic receptor antagonist with antihypertensive properties and devoid of intrinsic sympathomimetic activity.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Antihypertensive
Monograph Status	USP-A, EP-A
Granules Product Status	Commercially Available
Regulatory Filing/Technical Package	US DMF, CEP
Innovator Brands	Kapspargo Sprinkle, Toprol-Xl
Available dosage Form/Strength	Capsule ER(EQ 25/50/100/200 mg tartarate); Tablet ER (EQ 25/50/100/200 mg tartarate)

Naproxen Sodium, USP

CAS Number: 26159-34-2

Description

Naproxen Sodium is the sodium salt form of naproxen, a member of the arylacetic acid group of non-steroidal anti-inflammatory drugs (NSAIDs) with anti-inflammatory analgesic and antipyretic properties.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Anti-inflammatory agent
Monograph Status	A
Granules Product Status	Commercially Not Available
Regulatory Filing/Technical Package	US DMF
Innovator Brands	Aleve, Naprelan
Available dosage Form/Strength	Capsule (EQ 20mg Base), Tablet(Eq 220/ 250/ 500mg Base), Tablet ER (EQ 375/ 500/750mg Base)

Penicillamine USP

CAS Number: 52-67-5

Description

Penicillamine is a pharmaceutical of the chelator class. The pharmaceutical form is D-penicillamine.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Chelating agent
Monograph Status	A
Granules Product Status	Commercially Available
Regulatory Filing/Technical Package	US DMF
Innovator Brands	Cuprimine, Depen
Available dosage Form/Strength	Capsule (250/125mg), Tablet(250mg)

Pirfenidone

CAS Number: 53179-13-8

Description

Pirfenidone is an orally active synthetic antifibrotic agent structurally similar to pyridine 2,4-dicarboxylate. Pirfenidone inhibits fibroblast, epidermal, platelet-derived, and transforming beta-1 growth factors, thereby slowing tumor cell proliferation.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Antifibrotic agent
Monograph Status	USP-NA, EP-A
Granules Product Status	Commercially Available
Regulatory Filing/Technical Package	US DMF, CEP
Innovator Brands	Esbriet
Available dosage Form/Strength	Tablet(267/534/801mg), Capsule (267mg)

Vigabatrin USP

CAS Number: 68506-86-5

Description

Vigabatrin is an analog of gamma-aminobutyric acid ([GABA]), the main inhibitory neurotransmitter in the central nervous system, used in the treatment of refractory seizures and infantile spasms.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Anticonvulsant
Monograph Status	A
Granules Product Status	Commercially Available
Regulatory Filing/Technical Package	US DMF
Innovator Brands	Sabril
Available dosage Form/Strength	Tablet(500mg), Oral solution (500mg/Packet)

Tenofovir Disoproxil Succinate

CAS Number: 1637632-97-3

Description

(R)-9-(2-Phosphonylmethoxypropyl)adenine (PMPA known as tenofovir) is an antiviral drug. Diphosphate of PMPA acts as a selective inhibitor of the HIV-1 reverse transcriptase.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Antiretroviral
Monograph Status	NA
Granules Product Status	Commercially Available
Regulatory Filing/Technical Package	ASMF
Innovator Brands	Viread
Available dosage Form/Strength	Tablet (150/200/250/300 mg), Powder (40mg/ Scoopful)

Abacavir Sulfate Ph Eur

CAS Number: 188062-50-2

Description

Abacavir Sulfate is a sulfate salt form of abacavir, a nucleoside reverse transcriptase inhibitor analog of guanosine. This agent decreases HIV viral loads, retards or prevents the damage to the immune system, and reduces the risk of developing AIDS. NCI Thesaurus (NCIt).

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Antiretroviral
Monograph Status	A
Granules Product Status	Commercially Available
Regulatory Filing/Technical Package	CEP
Innovator Brands	Ziagen
Available dosage Form/Strength	Tablet(EQ 300mg Base), Oral Solution (EQ 20mg Base/ml)

Capecitabine, Ph.Eur

CAS Number: 154361-50-9

Description

Capecitabine is a non-cytotoxic fluoropyrimidine carbamate, which functions as an orally administered precursor of the cytotoxic moiety 5-fluorouracil (5-FU).

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Oncology
Monograph Status	A
Granules Product Status	Commercially Available
Regulatory Filing/Technical Package	CEP
Innovator Brands	Xeloda
Available dosage Form/Strength	Tablet (150/500 mg)

Darunavir Amorphous

CAS Number: 206361-99-1

Description

Darunavir is in a class of medications called protease inhibitors. It works by decreasing the amount of HIV in the blood.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Antiretroviral
Monograph Status	NA
Granules Product Status	Commercially Available
Regulatory Filing/Technical Package	ASMF
Innovator Brands	Xeloda
Available dosage Form/Strength	Tablet (75/150/300/400/600/800 mg); Suspension Oral(100mg/ml)

Naproxen Sodium

CAS Number: 26159-34-2

Description

Naproxen Sodium is the sodium salt form of naproxen, a member of the arylacetic acid group of non-steroidal anti-inflammatory drugs (NSAIDs) with anti-inflammatory analgesic and antipyretic properties.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Anti-inflammatory agent
Monograph Status	A
Granules Product Status	Commercially Available
Regulatory Filing/Technical Package	Technical Package Available
Innovator Brands	Aleve, Naprelan
Available dosage Form/Strength	Capsule (EQ 20mg Base), Tablet(Eq 220/ 250/ 500mg Base), Tablet ER (EQ 375/ 500/750mg Base)

Penicillamine

CAS Number: 52-67-5

Description

Penicillamine is a pharmaceutical of the chelator class. The pharmaceutical form is D-penicillamine.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Chelating Agent
Monograph Status	A
Granules Product Status	Commercially Not Available
Regulatory Filing/Technical Package	Technical Package Available
Innovator Brands	Cuprimine, Depen
Available dosage Form/Strength	Capsule (250/125mg), Tablet(250mg)

Compresso PAP 90 CPC

Description

White, free flowing granules containing 90% of Acetaminophen/Paracetamol USP active ingredient and required quantities of excipients.

PFI TYPE	NA
Quality	ICH
Therapeutic Category	Analgesic, Antipyretic
Monograph Status	NA
Granules Product Status	Commercial Available
Regulatory Filing/Technical Package	GGP - US, Canada, and Australia
Innovator Brands	NA
Dosage Form	NA

Compresso PAP 90 CPC

Description

White, free flowing granules containing 90% of Acetaminophen/Paracetamol USP active ingredient and required quantities of excipients.

PFI TYPE	NA
Quality	ICH
Therapeutic Category	Analgesic, Antipyretic
Monograph Status	NA
Granules Product Status	Commercial Available
Regulatory Filing/Technical Package	JDM - Australia and Australia
Innovator Brands	NA
Dosage Form	NA

Compresso PAP 90 CPF

Description

White, free flowing granules containing 90% of Acetaminophen active ingredient and required quantities of excipients.

PFI TYPE	NA
Quality	ICH
Therapeutic Category	Analgesic, Antipyretic
Monograph Status	NA
Granules Product Status	Commercial Available
Regulatory Filing/Technical Package	US, Canada, and Australia
Innovator Brands	NA
Dosage Form	NA

Compresso PAP 90 CPL

Description

White, free flowing granules containing 90% of Acetaminophen active ingredient and required quantities of excipients.

PFI TYPE	NA
Quality	ICH
Therapeutic Category	Analgesic, Antipyretic
Monograph Status	NA
Granules Product Status	Commercial Available
Regulatory Filing/Technical Package	US DMF
Innovator Brands	NA
Dosage Form	NA

Compresso PAP 83.3 S

Description

White free flowing directly compressible granules containing Paracetamol Ph.Eur and required quantities of excipients.

PFI TYPE	NA
Quality	ICH
Therapeutic Category	Analgesic, Antipyretic
Monograph Status	NA
Granules Product Status	Commercial Available
Regulatory Filing/Technical Package	Europe
Innovator Brands	NA
Dosage Form	NA

Compresso PAP 77 P

Description

White free flowing directly compressible granules containing Paracetamol and required quantities of excipients.

PFI TYPE	NA
Quality	ICH
Therapeutic Category	Analgesic, Antipyretic
Monograph Status	NA
Granules Product Status	Commercial Available
Regulatory Filing/Technical Package	Europe
Innovator Brands	NA
Dosage Form	NA

Compresso MF 95 P

Description

White, free flowing granules containing 95% of Metformin HCl active ingredient and required quantities of excipients.

PFI TYPE	NA
Quality	ICH
Therapeutic Category	Analgesic, Antipyretic
Monograph Status	NA
Granules Product Status	Commercial Available
Regulatory Filing/Technical Package	US, and Canada
Innovator Brands	NA
Dosage Form	NA

Compresso MF 90 P

Description

White, free flowing directly compressible granules containing Metformin Hydrochloride USP/Ph. Eur. and required quantities of excipients.

PFI TYPE	NA
Quality	ICH
Therapeutic Category	Analgesic, Antipyretic
Monograph Status	NA
Granules Product Status	Commercial Available
Regulatory Filing/Technical Package	Tech Pack
Innovator Brands	NA
Dosage Form	NA

Metho 90 DC

Description

White, to off white free flowing directly compressible granules consisting of Methocarbamol and other required quantity of excipients.

PFI TYPE	NA
Quality	ICH
Therapeutic Category	Analgesic, Antipyretic
Monograph Status	NA
Granules Product Status	Commercial Available
Regulatory Filing/Technical Package	Canada
Innovator Brands	NA
Dosage Form	NA

Compresso IBU 90 CP

Description

White, to off white free flowing directly compressible granules consisting of Methocarbamol and other required quantity of excipients.

PFI TYPE	NA
Quality	ICH
Therapeutic Category	Analgesic, Antipyretic
Monograph Status	NA
Granules Product Status	Commercial Available
Regulatory Filing/Technical Package	Singapore
Innovator Brands	NA
Dosage Form	NA

Compresso IBU 66 S

Description

White, free flowing directly compressible granules consisting of Ibuprofen and other required Quantity of excipients.

PFI TYPE	NA
Quality	ICH
Therapeutic Category	Analgesic, Antipyretic
Monograph Status	NA
Granules Product Status	Commercial Available
Regulatory Filing/Technical Package	US DMF
Innovator Brands	NA
Dosage Form	NA

Compresso GGF 95 SA

Description

White, free flowing granules containing 95% Guaifenesin active ingredient and required quantities of excipients.

PFI TYPE	NA
Quality	ICH
Therapeutic Category	Analgesic, Antipyretic
Monograph Status	NA
Granules Product Status	Commercial Available
Regulatory Filing/Technical Package	US DMF
Innovator Brands	NA
Dosage Form	NA

Compresso PAP 96 P

Description

White to Off-white free flowing granules containing 96% of Paracetamol Ph. Eur active ingredient and required quantities of excipients.

PFI TYPE	NA
Quality	ICH
Therapeutic Category	Analgesic, Antipyretic
Monograph Status	NA
Granules Product Status	Commercial Available
Regulatory Filing/Technical Package	Tech Pack
Innovator Brands	NA
Dosage Form	NA

Compresso PAP 90 CPP

Description

White, free flowing directly compressible granules containing Acetaminophen/Paracetamol and required quantities of excipients.

PFI TYPE	NA
Quality	ICH
Therapeutic Category	Analgesic, Antipyretic
Monograph Status	NA
Granules Product Status	Commercial Available
Regulatory Filing/Technical Package	US, Canada, and Australia
Innovator Brands	NA
Dosage Form	NA

Compresso PAP 90 CPU

Description

White, free flowing directly compressible granules containing Acetaminophen / Paracetamol and required quantities of excipients.

PFI TYPE	NA
Quality	ICH
Therapeutic Category	Analgesic, Antipyretic
Monograph Status	NA
Granules Product Status	Commercial Available
Regulatory Filing/Technical Package	Tech Pack
Innovator Brands	NA
Dosage Form	NA

Compresso PAP 90 CPM

Description

White, free flowing directly compressible granules containing Acetaminophen/Paracetamol USP/Ph.Eur and Chlorpheniramine Maleate USP. and required quantities of excipients.

PFI TYPE	NA
Quality	ICH
Therapeutic Category	Analgesic, Antipyretic
Monograph Status	NA
Granules Product Status	Commercial Available
Regulatory Filing/Technical Package	Tech Pack
Innovator Brands	NA
Dosage Form	NA

Compresso PAP 90 P

Description

White, free flowing granules containing Paracetamol required quantities of excipients.

PFI TYPE	NA
Quality	ICH
Therapeutic Category	Analgesic, Antipyretic
Monograph Status	NA
Granules Product Status	Commercial Available
Regulatory Filing/Technical Package	Tech Pack
Innovator Brands	NA
Dosage Form	NA

Compresso PAP 87S

Description

White odourless crystalline powder.

PFI TYPE	NA
Quality	ICH
Therapeutic Category	Analgesic, Antipyretic
Monograph Status	NA
Granules Product Status	Commercial Available
Regulatory Filing/Technical Package	Tech Pack
Innovator Brands	NA
Dosage Form	NA

Compresso IBU 85

Description

White to off white granules containing Ibuprofen and required quantities of excipients.

PFI TYPE	NA
Quality	ICH
Therapeutic Category	Analgesic, Antipyretic
Monograph Status	NA
Granules Product Status	Commercial Available
Regulatory Filing/Technical Package	Tech Pack
Innovator Brands	NA
Dosage Form	NA

Compresso IBU 66

Description

White, free flowing directly compressible granules consisting of Ibuprofen and other required Quantity of excipients.

PFI TYPE	NA
Quality	ICH
Therapeutic Category	Analgesic, Antipyretic
Monograph Status	NA
Granules Product Status	Commercial Available
Regulatory Filing/Technical Package	Tech Pack
Innovator Brands	NA
Dosage Form	NA

Compresso IBU 56 SE

Description

Ibuprofen: White to off-white, crystalline powder, having a slight, characteristic odour.

Pseudoephedrine Hydrochloride

Fine, White to off-white, crystalline or powder, having a faint characteristic odour.

PFI TYPE	NA
Quality	ICH
Therapeutic Category	Analgesic, Antipyretic
Monograph Status	NA
Granules Product Status	Commercial Available
Regulatory Filing/Technical Package	Tech Pack
Innovator Brands	NA
Dosage Form	NA

Compresso NAP 73.3

Description

White to off white, free flowing granules and free from any visible extraneous matter.

PFI TYPE	NA
Quality	ICH
Therapeutic Category	Analgesic, Antipyretic
Monograph Status	NA
Granules Product Status	Commercial Available
Regulatory Filing/Technical Package	Tech Pack
Innovator Brands	NA
Dosage Form	NA

Compresso GEM 70

Description

White, free flowing directly compressible granules containing Gemfibrozil and required quantities of excipients.

PFI TYPE	NA
Quality	ICH
Therapeutic Category	Analgesic, Antipyretic
Monograph Status	NA
Granules Product Status	Commercial Available
Regulatory Filing/Technical Package	Tech Pack
Innovator Brands	NA
Dosage Form	NA

Compresso CIP 65

Description

Faintly yellowish to light yellowish free flowing directly compressible granules containing Ciprofloxacin HCl equivalent to Ciprofloxacin and required quantities of excipients.

PFI TYPE	NA
Quality	ICH
Therapeutic Category	Analgesic, Antipyretic
Monograph Status	NA
Granules Product Status	Commercial Available
Regulatory Filing/Technical Package	Tech Pack
Innovator Brands	NA
Dosage Form	NA

Tenofovir Disoproxil Succinate

Description

(R)-9-(2-Phosphonylmethoxypropyl)adenine (PMPA known as tenofovir) is an antiviral drug. Diphosphate of PMPA acts as a selective inhibitor of the HIV-1 reverse transcriptase.

API TYPE	Synthetic chemistry
Quality	ICH
Therapeutic Category	Antiretroviral
Monograph Status	NA
Granules Product Status	Commercial Available
Regulatory Filing/Technical Package	ASMF
Innovator Brands	--
Dosage Form	Tablet (12.5/25/50/75/100mg),For suspension(12.5/25mg Packet)

Methocarbamol USP

Description

Methocarbamol is a carbamate with centrally acting muscle relaxant properties. Though the exact mechanism of action of methocarbamol was not established, it's postulated to be via a mechanism similar of carbamate, inhibition of acetylcholinesterase at synapses in the autonomic nervous system, neuromuscular junction, and central nervous system.

API TYPE	Synthetic chemistry
Quality	ICH
Therapeutic Category	Muscle relaxant (Skeletal)
Monograph Status	NA
Granules Product Status	Not Available
Regulatory Filing/Technical Package	ASMF
Innovator Brands	--
Dosage Form	Tablet (12.5/25/50/75/100mg),For suspension(12.5/25mg Packet)

Abacavir Sulfate Ph Eur

CAS Number: 188062-50-2

Description

Abacavir Sulfate is a sulfate salt form of abacavir, a nucleoside reverse transcriptase inhibitor analog of guanosine. This agent decreases HIV viral loads, retards or prevents the damage to the immune system, and reduces the risk of developing AIDS. NCI Thesaurus (NCIt).

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Antiretroviral
Monograph Status	A
Granules Product Status	Commercially Available
Regulatory Filing/Technical Package	CEP
Innovator Brands	--
Dosage Form	--

Paracetamol, Ph. Eur

CAS Number: 103-90-2

Description

Acetaminophen is a nonnarcotic analgesic and antipyretic drug.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Analgesic, Antipyretic
Monograph Status	A
Granules Product Status	Commercially Available
Regulatory Filing/Technical Package	CEP
Innovator Brands	--
Dosage Form	--

Capecitabine, Ph.Eur

CAS Number: 154361-50-9

Description

Capecitabine is a non-cytotoxic fluoropyrimidine carbamate, which functions as an orally administered precursor of the cytotoxic moiety 5-fluorouracil (5-FU).

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Antineoplastic
Monograph Status	A
Granules Product Status	Commercially Available
Regulatory Filing/Technical Package	CEP
Innovator Brands	--
Dosage Form	--

Darunavir Amorphous

CAS Number: 206361-99-1

Description

Darunavir is in a class of medications called protease inhibitors. It works by decreasing the amount of HIV in the blood.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Antiretroviral
Monograph Status	NA
Granules Product Status	Commercially Available
Regulatory Filing/Technical Package	ASMF
Innovator Brands	--
Available dosage Form/Strength	--

Fluconazole

CAS Number: 86386-73-4

Description

Fluconazole is a synthetic triazole with antifungal activity. Fluconazole preferentially inhibits fungal cytochrome P-450 sterol C-14 alpha-demethylation, resulting in the accumulation of fungal 14 alpha-methyl sterols, the loss of normal fungal sterols, and fungistatic activity.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Antifungal
Monograph Status	A
Granules Product Status	Commercially Available
Regulatory Filing/Technical Package	CEP
Innovator Brands	--
Available dosage Form/Strength	--

Levocetirizine

CAS Number: 130018-87-0

Description

Levocetirizine is an antihistamine used to relieve allergy symptoms.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Antihistamine
Monograph Status	NA
Granules Product Status	Commercially Available
Regulatory Filing/Technical Package	ASMF
Innovator Brands	--
Available dosage Form/Strength	--

Losartan Potassium, Ph.Eur

CAS Number: 124750-99-8

Description

Losartan potassium is an angiotensin II receptor blocker acting on the AT1 receptor subtype.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Antihypertensive
Monograph Status	A
Granules Product Status	Commercially Available
Regulatory Filing/Technical Package	CEP
Innovator Brands	--
Available dosage Form/Strength	--

Metformin Hydrochloride (BPL Site)

CAS Number: 1115-70-4

Description

Metformin is an anti-diabetic medication (biguanide). It works by lowering glucose production in the liver, delaying the absorption of sugar (glucose) from the intestines, and increasing the body's sensitivity to insulin.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Hypoglycemic
Monograph Status	A
Granules Product Status	Commercially Available
Regulatory Filing/Technical Package	CEP
Innovator Brands	--
Available dosage Form/Strength	--

Metformin Hydrochloride

CAS Number: 1115-70-4

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Hypoglycemic
Monograph Status	A
Granules Product Status	Commercially Available
Regulatory Filing/Technical Package	CEP
Innovator Brands	--
Available dosage Form/Strength	--

Metoprolol Succinate

CAS Number: 98418-47-4

Description

Metoprolol Succinate is the succinate salt form of metoprolol, a cardioselective competitive beta-1 adrenergic receptor antagonist with antihypertensive properties and devoid of intrinsic sympathomimetic activity.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Antihypertensive, Antianginal & Heart Failure
Monograph Status	A
Granules Product Status	Commercially Unavailable
Regulatory Filing/Technical Package	CEP
Innovator Brands	--
Available dosage Form/Strength	--

Naproxen Sodium

CAS Number: 26159-34-2

Description

Naproxen Sodium is the sodium salt form of naproxen, a member of the arylacetic acid group of non-steroidal anti-inflammatory drugs (NSAIDs) with anti-inflammatory analgesic and antipyretic properties.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Anti-inflammatory agent with analgesic and antipyretic
Monograph Status	A
Granules Product Status	Commercially Unavilable
Regulatory Filing/Technical Package	Technical Package Available
Innovator Brands	--
Available dosage Form/Strength	--

Penicillamine

CAS Number: 52-67-5

Description

Penicillamine is a pharmaceutical of the chelator class. The pharmaceutical form is D-penicillamine.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	For treatment of Wilson's disease, cystinuria and active rheumatoid arthritis
Monograph Status	A
Granules Product Status	Commercially Unavialable
Regulatory Filing/Technical Package	Technical Package Available
Innovator Brands	--
Available dosage Form/Strength	--

Pirfenidone

CAS Number: 53179-13-8

Description

Pirfenidone is an orally active synthetic antifibrotic agent structurally similar to pyridine 2,4-dicarboxylate. Pirfenidone inhibits fibroblast, epidermal, platelet-derived, and transforming beta-1 growth factors, thereby slowing tumor cell proliferation.

API Type	Synthetic chemistry
Quality	ICH
Therapeutic Category	Antifibrotic agent
Monograph Status	USP-NA, EP-A
Granules Product Status	Commercially Available
Regulatory Filing/Technical Package	CEP
Innovator Brands	--
Available dosage Form/Strength	--

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