Granules unit in Andhra Pradesh gets U.S. FDA inspection report with NAI status
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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 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 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 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 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 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 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 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 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 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 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) |
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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) |
(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 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 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 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 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 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) |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
Ibuprofen: White to off-white, crystalline powder, having a slight, characteristic odour.
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 |
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 |
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 |
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 |
(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 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 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 | -- |
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 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 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 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 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 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 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 | -- |
| 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 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 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 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 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 | -- |
