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NEW DELHI: The US Food and Drug Administration (USFDA) had issued six observations to Granules India‘s Gagillapur facility in Hyderabad, following a recent inspection.
The US regulator conducted an inspection at the company’s facility between August 26 and September 6, which resulted in a Form 483 being issued. The issuance of Form 483 implies that the regulator found certain procedural lapses at the plant, and would seek corrective action from the company.
The Granules India scrip slumped by over 16% to Rs 564.70 in afternoon trade on BSE.
The Gagillapur facility is responsible for manufacturing finished dosages and pharmaceutical formulation intermediates.
The company said in a BSE filing on September 7 that it is committed to addressing the observations promptly, and will submit its response to the USFDA within the stipulated time frame.
It had also announced the completion of the USFDA inspection at the facility, and about the six observations. The recent inspection covered both current good manufacturing practice (cGMP) and pre-approval inspection (PAI) processes.
The Gagillapur facility continues to play a vital role in the company’s global operations, ensuring the supply of high-quality pharmaceutical products to markets worldwide, it added.
The US regulator conducted an inspection at the company’s facility between August 26 and September 6, which resulted in a Form 483 being issued. The issuance of Form 483 implies that the regulator found certain procedural lapses at the plant, and would seek corrective action from the company.
The Granules India scrip slumped by over 16% to Rs 564.70 in afternoon trade on BSE.
The Gagillapur facility is responsible for manufacturing finished dosages and pharmaceutical formulation intermediates.
The company said in a BSE filing on September 7 that it is committed to addressing the observations promptly, and will submit its response to the USFDA within the stipulated time frame.
It had also announced the completion of the USFDA inspection at the facility, and about the six observations. The recent inspection covered both current good manufacturing practice (cGMP) and pre-approval inspection (PAI) processes.
The Gagillapur facility continues to play a vital role in the company’s global operations, ensuring the supply of high-quality pharmaceutical products to markets worldwide, it added.
