Pirfenidone is the generic version of ESBRIET, developed by Roche and approved by USFDA in 2014. It is indicated to treat Idiopathic Pulmonary Fibrosis (IPF) and has demonstrated a combined anti-inflammatory, anti-oxidant and anti-fibrotic action, consisting in the regulation of the expression of TGF-β and inhibition of fibroblast and collagen synthesis. Pirfenidone has got an Orphan designation in the USA.

5-methyl-1-phenylpyridin-2-one

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Epalrestat is the generic version of KINEDAK, developed by Ono Pharmaceutical Co Ltd and approved by PMDA in 1992. It is an aldose reductase inhibitor that is indicated to treat Diabetic Peripheral Neuropathy. As per studies, currently, plethora of drugs developed which prevents nerves damage but the most effective drugs would be inhibitors of nerve damage process like Aldose Reductase Inhibitor (ARI). These drugs could offer the advantage of being effective even with persistent hyperglycaemia. Epalrestat is a non – competitive inhibitor of aldose reductase, the rate-limiting enzyme in the polyol pathway.

2-[(5Z)-5-[(E)-2-methyl-3-phenylprop-2-enylidene]-4-oxo-2-sulfanylidene-1, 3-thiazolidin-3-yl] acetic acid

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Oxcarbazepine is the generic version of TRILEPTAL, an Anticonvulsant drug, developed by Novartis Pharmaceuticals, approved by USFDA in 2000 for treating Partial Seizures. The drug enhances slow inactivation of voltage-sensitive sodium channels, thus leading to stabilization of hyper-exited neuronal membranes and subsequently reduces the activity of rapidly firing neurons^.This drug comes with a demonstrated safety vs. efficacy profile.

5-oxo-6H-benzo[b] [1] benzazepine-11-carboxamide

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Eltrombopag is the generic version of PROMACTA. It is an orally bioavailable, small-molecule, Thrombopoietin – Receptor Agonist (TPO-RA) developed by Novartis and approved by USFDA in 2008 for the treatment of Thrombocytopenia in patients with ITP (Idiopathic Thrombocytopenia) in adults and pediatrics, Thrombocytopenia in patients with Hepatitis C, and treatment of Severe Aplastic Anemia. Eltrombopag has a good safety and efficacy profile.

3-[3-[[2-(3, 4-dimethylphenyl)-5-methyl-3-oxo-1H-pyrazol-4-yl] diazenyl]-2-hydroxyphenyl] benzoic acid

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Ticagrelor, the generic version of BRILINTA, developed by AstraZeneca and approved by USFDA in 2011. It inhibits platelet aggregation by antagonizing the P2Y12 receptor. It is indicated to reduce the rate of cardiovascular death, Myocardial Infarction, and Stroke in patients with Acute Coronary Syndrome (ACS) or a history of Myocardial Infarction (MI), it also reduces the risk of Stent Thrombosis. As per studies, Ticagrelor exhibited a more favorable efficacy vs. safety profile over the other drugs.

(1S, 2S, 3R, 5S)-3-[7-[[(1R, 2S)-2-(3, 4-difluorophenyl) cyclopropyl] amino]-5-propylsulfanyltriazolo [4, 5-d] pyrimidin-3-yl]-5-(2-hydroxyethoxy) cyclopentane-1, 2-diol

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Vilanterol, the generic version of BREO ELLIPTA, a fixed dose combination with Fluticasone furoate, it was approved by USFDA in 2013 for treating Chronic Obstructive Pulmonary Disease (COPD). Vilanterol (VI) is a long‐acting beta₂‐agonist (LABA) that binds to the beta₂‐adrenoceptor on the airway smooth muscle, producing bronchodilation. This drug has a good safety profile.

4-[(1R)-2-[6-[2-[(2, 6-dichlorophenyl) methoxy] ethoxy] hexylamino]-1-hydroxyethyl]-2-(hydroxymethyl) phenol

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Ponesimod, the generic version of PONVORY is a Sphingosine 1-Phosphate receptor modulator, developed by Janssen Pharmaceuticals and approved by USFDA in March, 2021 for treating various forms of Multiple Sclerosis. As per the innovator, Ponesimod has exhibited a superior efficacy compared to Teriflunomide and it is at par with the other S1P modulators. Hence, it forms a good NCE-1 opportunity for the generic drug manufacturers.

(5Z)-5-[[3-chloro-4-[(2R)-2, 3-dihydroxypropoxy] phenyl] methylidene]-3-(2-methylphenyl)-2-propylimino-1, 3-thiazolidin-4-one

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Fexuprazan being developed by Daewoong Pharmaceuticals is investigational Potassium-Competitive Acid Blocker (P-CAB), a next generation, novel Antiulcerative/Antacid. P-CABs work by inhibiting acid secretion by competitively blocking availability of potassium to H⁺-K⁺ ATPase in both active and resting proton pumps. Its efficacy is superior to the conventional PPIs. The innovator states that they have completed the phase III clinical trials and are looking for partnerships to commercialize Fexuprazan in global markets such as the US and China. There is no approved P-CAB in the US so far, hence Fexuprazan if approved, could capture a good share in the Antiulcerative/Antacid drugs market.

1-[5-(2, 4-difluorophenyl)-1-(3-fluorophenyl) sulfonyl-4-methoxypyrrol-3-yl]-N-methylmethanamine

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Lacosamide is the generic version of VIMPAT, an Anticonvulsant drug, developed by UCB Pharma and approved by USFDA in 2008 for treating Partial Seizures. It works by selectively enhancing slow inactivation of sodium channels. This drug comes with a balanced efficacy vs. safety profile.

(2R)-2-acetamido-N-benzyl-3-methoxypropanamide

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Vibegron, the generic version of GEMTESA is the latest entrant into the Overactive Bladder therapeutic segment. It was developed by Urovant Sciences and has been approved by the USFDA in Dec, 2020. Unlike the older antimuscarinic agents that are known to cause troublesome anticholinergic adverse effects, Vibegron is a Beta 3 agonist that comes with a similar efficacy and is devoid of any such adverse drug reactions. Hence, this drug could be a good bet for the generic drug companies to look for the NCE-1 opportunity.

(6S)-N-[4-[[(2S,5R)-5-[(R)-hydroxy(phenyl)methyl]pyrrolidin-2-yl]methyl]phenyl]-4-oxo-7,8-dihydro-6H-pyrrolo[1,2-a]pyrimidine-6-carboxamide

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Rasagiline is the generic version of AZILECT, developed by Teva Pharmaceuticals and approved by EMA in 2005 and USFDA in 2006. It is an irreversible inhibitor of Monoamine Oxidase –B (MAO-B) indicated to treat Parkinson’s Disease. This drug offers a balanced safety vs. efficacy profile.

(1R)-N-prop-2-ynyl-2, 3-dihydro-1H-inden-1-amine

Piribedil, the generic version of TRIVASTAL, developed by Servier SA and approved by EMA in 1969. It is a Dopamine D2 and D3 receptor agonist indicated for treating Parkinson’s disease. The efficacy and safety of this drug is good.

2-[4-(1, 3-benzodioxol-5-ylmethyl) piperazin-1-yl] pyrimidine

Rosuvastatin, the generic version of CRESTOR, developed by AstraZeneca and approved by USFDA in 2003 is a HMG-CoA reductase inhibitor that is indicated to treat Hypercholesterolemia. Rosuvastatin has a proven efficacy record. Unlike most of the older statins which works best if taken only at night, Rosuvastatin has no such restriction and can be taken at anytime owing to its longer half life.

(E, 3R, 5S)-7-[4-(4-fluorophenyl)-2-[methyl (methylsulfonyl) amino]-6-propan-2-ylpyrimidin-5-yl]-3, 5-dihydroxyhept-6-enoic acid

Nelfinavir is an antiretroviral drug that belongs to the class of Protease inhibitors. It is the generic version of VIRACEPT, developed by GlaxoSmithKline and approved by USFDA in 1997 for treating HIV infection. This drug has a balanced safety vs. efficacy profile.

(3S, 4aS, 8aS)-N–tert-butyl-2-[(2R, 3R)-2-hydroxy-3-[(3-hydroxy-2-methylbenzoyl) amino]-4-phenylsulfanylbutyl]-3, 4, 4a, 5, 6, 7, 8, 8a-octahydro-1H-isoquinoline-3-carboxamide

Apremilast is the generic version of OTEZLA, developed by Amgen and approved by USFDA in 2014. It is a selective phosphodiesterase 4 inhibitor, indicated to treat Plaque Psoriasis and Psoriatic Arthritis. Apremilast has a reliable safety vs. efficacy profile.

N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-1, 3-dioxoisoindol-4-yl] acetamide

Cenobamate the newest entrant into the Antiepileptic drug category is the generic version of XCOPRI developed by SK Life Science Inc and approved by USFDA in 2020. This drug has shown a great efficacy in treating Partial Seizures. Cenobamate has all the potential to achieve a blockbuster status in the Antiepileptic drugs market. Hence, this drug forms a captivating NCE-1 opportunity for the generic pharma companies.

[(1R)-1-(2-chlorophenyl)-2-(tetrazol-2-yl) ethyl] carbamate

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MANUFACTURING FACILITY (UNIT IV – API & INTERMEDIATES)

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Visakhapatnam, Andhra Pradesh 531021

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Phase 1, IDA, Jeedimetla,
Hyderabad, Rangareddy, Telangana 500055

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MANUFACTURING FACILITY (UNIT C – INTERMEDIATES)

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PLOT NO:1-184.SY NO 298/PART
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Hyderabad, Rangareddy, Telangana 500055

MANUFACTURING FACILITY (UNIT I – API)

Plot No.62/C/6. Pipe Line Road,
Phase 1, IDA, Jeedimetla,
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