Active Pharmaceutical Ingrediants - Overview

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Overview

"Morepen is a well-known pharma company having well equipped Research & Development Centre and is all set to seize the Generic revolution in pharma industry, by filing multiple DMFs and COS for new APIs. This is a highly focused and dynamic business model that allows Morepen to optimize its core competencies and also allows focus on products that have synergies with respect to the Company’s current chemistry skills. The R&D center at Masulkhana, Parwanoo and Baddi is well equipped and hi-technology based with over 20 scientists working on various projects primarily for new innovative non-infringing processes and development of cost effective proprietary technologies. The company has filed 72 patents/patents Applications and more than 23 DMFs/ COS. Morepen’s Masulkhana facility is approved by USFDA for Loratadine and Desloratadine along with EDQM approval for Montelukast Sodium and Desloratadine. Morepen is world’s largest generic player of Loratadine with over 80% US generics market share. Morepen was recently granted TGA approval for Loratadine also. Apart from this, Morepen’s Baddi facility is also approved by EDQM for Atorvastatin calcium.

Morepen has been granted an international patent on process for amorphous form of the cholesterol-reducing world’s largest selling drug Lipitor (Atorvastatin Calcium) in US & Canada. Morepen has USDMF, COS & TDMF for Atorvastatin Calcium Crystalline Trihydrate.



Morepen has been recently granted patent on another complex block buster molecule Montelukast Sodium in US, Europe & Canada for recently developed non-infringing process. Morepen has USDMF, COS & IDL China for Montelukast Sodium also.

Morepen is among the top players in the production of Block Buster drugs, Atorvastatin (Lipitor) and Montelukast (Singulair). Morepen has also filed COS for Fexofenadine. Morepen is also selling key Intermediates of Loratadine, Atorvastatin & Fexofenadine to top Generics companies.

Towards its journey of profitable growth and technological advancement & strengthening the company, various process as well as polymorph patent applications have been filed by Morepen for various products like Rosuvastatin calcium, Sitagliptin Phosphate, Fexofenadine Hydrochloride, Loratadine, Atorvastatin calcium. Morepen has developed New polymorphs of Rosuvastatin calcium and Sitagliptin Phosphate followed by filing of their polymorph patents. Rosuvastatin calcium & Sitagliptin Phosphate have also been commercialized. The COS for Rosuvastatin has been filed whereas COS filing for Sitagliptin is planned for the current year. Apart from this, anti-hypersensitive drug Olmesartan Medoxomil has also been commercialized.

During the current year, other new products which were recently developed in R&D are alternative cost effective route of Sitagliptin Phosphate, Linagliptin and Candesartan Cilexetil. This new product basket has recorded sales revenue of Rs. 1,797 Lacs in the last financial year, which speaks immensely about potential of R&D. Morepen, is also working for capturing of highly sophisticated Japanese market for Loratadine, Montelukast, Atorvastatin, Fexofenadine & Olmesartan.

Other highly sensitive complex new products in the pipelines are Dapagliflozin, Canagliflozin, Empagliflozin, Apripitant, Fingolimod, Esomeprazole, Orlistat, Flibansarin etc.

Sophisticated, state-of-the art instruments like HPLC, GC, FTIR, UV spectrophotometer, XRD, 1H & 13C NMR and Mass instruments are used for standardization of manufacturing processes of APIs.

Morepen was awarded prestigious “Pharmexcil Patent Award” three times in 2010-11, 2011-12 & 2013-14” for granted patents of Montelukast Sodium & Atorvastatin calcium in US, Canada and Europe.

Furthermore, Morepen has chemistry skills for handling of complex chemical reactions including Grignard reaction, High pressure hydrogenation, Low temperature stereo specific reduction, Friedel craft alkylation/acylation, Vilsmair Haack reaction, Meerwin Arylation, Acetylation, Amino acid coupling, Amine/ hydroxy Deprotection, Cyanation, Hetero cyclization, Nucleophilic substitution, Condensation etc. at lab as well as at plant scale. Non-infringing processes for various APIs are developed for regulated markets. Study of Polymorphism for APIs is another chemistry strength which is used to develop new polymorphic forms as well as process for various APIs."