Ajanta Pharma receives final approval from USFDA for Entacapone Tablets

04 Sep 2017 Evaluate

Ajanta Pharma has received final approval from US Food and Drug Administration (USFDA) for Entacapone Tablets. It is a bioequivalent generic version of Comtan Tablets. The company will be launching the product shortly in 200mg strength tablets.

Entacapone Tablets is part of an ever growing portfolio of products that Ajanta has developed for the US market. In total, Ajanta has 35 Abbreviated New Drug Application (ANDA) of which it has final approvals for 20 ANDAs; tentative approvals for 2 ANDA; and 13 ANDAs are under review with USFDA.

Ajanta Pharma is a specialty pharmaceutical formulation company with global headquarters in Mumbai, India. Over 6,500 employees are engaged in developing, manufacturing and marketing of quality finished dosages across 30+ countries.



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