Concord Biotech's Valthera unit completes US FDA audit with one procedural observation

In a regulatory filing made during market hours today, the company stated that the US FDA had conducted an inspection at its formulation facility located at Unit II, Valthera., Dholka Taluka, Ahmadabad district, Gujarat.

The inspection has been successfully concluded with one minor procedural observation which is not related to GMP. The company will submit a comprehensive response to the observation within the stipulated timeline.

We do not expect this development to have any material impact on the current business operations or existing supplies from this facility, Concord Biotech said in a statement.

Concord Biotech is an R&D-driven biopharma company that manufactures Active Pharmaceutical Ingredients (APIs) through fermentation & semi-synthetic processes and finished formulations. It has a presence in more than 70 countries worldwide.

The company had reported 32.84% rise in consolidated net profit to Rs 58.53 crore on a 26.23% increase in revenue to Rs 257.49 crore in Q1 FY27 as compared with Q1 FY26.

The scrip rose 1.36% to currently trade at Rs 1481.95 on the BSE.

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