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Glenmark Pharma receives ANDA approval for Sodium Phenylbutyrate Tablets USP, 500 mg

Glenmark Pharma receives ANDA approval for Sodium Phenylbutyrate Tablets USP, 500 mg

Glenmark Pharmaceuticals has received final approval from the United States Food & Drug Administration (US FDA) for Sodium Phenylbutyrate Tablets USP, 500 mg, the generic version of Buphenyl 1 Tablets, 500 mg, of Horizon Therapeutics. Glenmark’s Sodium Phenylbutyrate Tablets USP, 500 mg, will be distributed in the US by Glenmark Pharmaceuticals, USA.

Glenmark’s current portfolio consists of 177 products authorised for distribution in the US marketplace and 46 ANDA’s pending approval with the US FDA. In addition to these internal filings, Glenmark continuest to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

More news about: quality / gmp | Published by Sudeep Soparkar | November - 03 - 2022 | 338

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