“US FDA conducted good manufacturing practices (GMP) inspection of the company’s finished dosage formulation facility (sterile and non-sterile) from 13-25, February 2020,” the company said in a BSE filing.
The facility is located at S-20 to S-26, pharmaceutical formulations SEZ, TSIIC, Jadcherla, Telangana State, India.
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The company is preparing responses to the observations, which will be submitted to the agency within 15 business days.
The company is committed to addressing these observations promptly.