Natco Pharma turns green on USFDA approval
DSIJ Intelligence / 24 Nov 2016
Natco Pharma has bagged final approval for its generic Budesonide capsules, 3 mg, for the US market. The company received Abbreviated New Drug Application (ANDA) from the US Food and Drug Administration (FDA) for generic version of Budesonide capsules (Enteric coated), 3 mg.
Natco Pharma has bagged final approval for its generic Budesonide capsules, 3 mg, for the US market. The company received Abbreviated New Drug Application (ANDA) from the US Food and Drug Administration (FDA) for generic version of Budesonide capsules (Enteric coated), 3 mg. Natco Pharma and its marketing partner Alvogen plan to launch this product in the US market immediately.
Perrigo Pharma International DAC sells Budesonide capsules under their brand Entocort EC in the US market. Entocort EC capsules, 3 mg, and its generic versions had US sales of about USD 370 million (Rs 2,541 crore) for 12 months ending December 2015, according to IMS Health.
Natco Pharma has a pipeline of niche and complex generics products in the US. The company has 38 ANDA filings, including 16 Para IV filings with USFDA at the end of FY16, targeting a combined market of over USD 16.3 billion (Rs 111,917 crore). It has received 16 approved ANDAs (including 3 tentative approvals).
The share price of Natco Pharma increased 1.83 per cent on the bourses in early trades and is trading at Rs 590.3 on intraday basis.
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