Committed to maintain highest quality, FDA warning letter on Bardez plant won’t impact supplies: Glenmark

Glenmark’s current portfolio consists of 177 products authorised for distribution in the United States markets and 47 Abbreviated New Drug Applications (ANDAs) pending approval with the USFDA (Representative Image)

The US Food and Drug Administration’s (USFDA) strong-worded warning letter after inspection of Glenmark’s Bardez-based manufacturing facility in Goa, will not impact the existing supplies or revenues, said the company.

“The company believes that the warning letter will not have an impact on the existing supplies or revenues from the operations of this facility at Goa,” a company spokesperson told Moneycontrol.

The US FDA has issued a warning letter to Glenmark Pharmaceuticals Chairman and Managing Director Glenn Saldanha saying it found significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceutical products after inspecting the Bardez-based manufacturing facility in Goa.

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The company said it has informed in a disclosure statement issued on November 23 saying it received a Warning Letter issued by US FDA for its Goa (India) manufacturing facility following an inspection conducted in May 2022.

“The Warning Letter issued by the US FDA requires for some corrective and/or remediation measures to be undertaken by the Company at the facility,” the spokesperson said.

“As stated in the disclosure statement, the company is in the process of submitting the corrective and preventive action plan to the US FDA,” he added.

The US FDA in the warning letter issued after reviewing Glenmark’s response on June 12, 2022, said the firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed.

Glenmark has been asked to provide an independent assessment and remediation plan for the corrective action and preventive action (CAPA) programme.

Meanwhile, the company has said that it is committed to working along with the US FDA to implement all the necessary corrective and/or remediation measures actions required, to address the concerns at the earliest.

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“The company is committed to maintaining the highest quality and manufacturing standards at all its facilities across the globe,” the spokesperson said.

The UD FDA in its warning letter has said that Glenmark failed to establish adequate written procedures for production and process control designed to assure that the drug products it manufactures have the identity, strength, quality, and purity they purport or are represented to possess

The company has been asked to submit a detailed summary of the validation programme for ensuring a state of control throughout the product lifecycle, along with associated procedures.

“Describe your program for process performance qualification, and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control,” the warning letter said.

The warning letter also said that the Glenmark firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced.

The letter also said that Glenmark failed to establish and follow required laboratory control mechanisms.

The company has been asked to respond to FDA within 15 working days, specifying the corrective measures taken to address any violations and to prevent their recurrence.