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Sun Pharma gets USFDA nod for generic Mesalamine extended release capsules

12 May 2022 Evaluate

Sun Pharmaceutical Industries has received final approval from USFDA for its Abbreviated New Drug Application (ANDA) for generic Mesalamine Extended Release Capsules, 500 mg. The generic product approval is based on Pentasa Extended Release Capsules, 500mg as a reference product. Pentasa Extended Release Capsules, 500mg had annualized sales of approximately $213 million in USA. 

Sun Pharmaceutical Industries is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company.

Peers
Company Name CMP
Sun Pharma. Inds. 1782.00
Dr. Reddys Labs. 1208.00
Cipla 1334.00
Lupin 2010.00
Zydus Lifesciences 1138.50
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