Natco Pharma receives USFDA approval for generic version of Budesonide Capsules

24 Nov 2016 Evaluate

Natco Pharma has received final approval of Abbreviated New Drug Application (ANDA) from the US Food and Drug Administration (USFDA) for generic version of Budesonide Capsules (Enteric Coated), 3 mg. The pharma major and its marketing partner Alvogen plan to launch this product in the USA market immediately.

Perrigo Pharma International DAC sells Budesonide Capsules under their brand ENTOCORT in the USA market. ENTOCORT EC Capsules, 3 mg and its generic versions had US sales of approximately $ 370 million for twelve months ending December 2015, as per IMS Health.

Natco Pharma was promoted as a private company to be in the business of research, developing, manufacturing and marketing of pharmaceutical substances and finished dosage forms for Indian and International markets.


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