Why Glenmark Pharma Shares Fell 5%

Shares of Glenmark Pharmaceuticals Ltd. fell 5% on Monday after red flags were raised against its Goa formulation-manufacturing facility by the U.S. Food and Drug Administration.

On Nov. 22, the FDA sent a warning letter to Glenn Saldanha, managing director and chief executive officer at Glenmark Pharma.

"This warning letter summarises significant violations of current good manufacturing practise regulations for finished pharmaceuticals...Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated," the letter accessible on the FDA website said.

In its Nov. 23 disclosure, the company said, "The company does not believe that the warning letter will have an impact on the disruption of supplies or the existing revenues from the operations of this facility."

They are committed to working with the U.S. FDA to implement all the necessary corrective actions required to address the concerns at the earliest, it said.

The U.S. FDA said that they had reviewed in detail the company's June 12, 2022, response to the FDA Form 483, issued following the inspection of its facility from May 12, 2022, through May 20, 2022.

The investigators observed certain specific violations, and the responses to the findings were inadequate.

• Failure 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 had already been distributed: While the company on re-investigation did initiate a voluntary recall of a batch in June 2022, the response did not adequately address the failure to investigate the failure and its market impact at the time of occurrence, nor did it include an overall management strategy for improving all phases of investigations.

• Failure to establish adequate written procedures for production and process control designed to assure that the drug products have quality and purity: The regulator has asked the company to provide a detailed programme for designing, validating, maintaining, controlling, and monitoring each of the company's manufacturing processes and a detailed summary of its validation programme for ensuring a state of control throughout the product lifecycle, along with associated procedures.

• Failure to establish and follow required laboratory control mechanisms—integration of chromatographic peaks and for the review of chromatographic data processing: The company's response to this was inadequate since it did not commit to performing a retrospective review of all chromatographic data associated with the raw materials, active pharmaceutical ingredients, and drug products subject to chromatographic testing.

• Failure to prepare batch production and control records with complete information relating to the production and control: The company did not contain batch-specific data for compression machine reject limits. The response did not review the programmable logic control recipe data to ensure the reject limits were properly calculated and entered for all U.S.-distributed batches within expiration.

In addition to the following gaps identified by the FDA in the response given by Glenmark Pharma for the Form 483 observations, the regulator said, "The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations."

BQ Prime is awaiting a response to detailed email queries sent to the company around the U.S. revenue contribution from the facility to the overall revenue, pending product approvals from the facilities, revised timelines, the corrective actions being taken, and revised response filing timelines.

The stock was trading 2.66% lower at end of trading hours compared to the benchmark Sensex, which was down 0.08%.