USFDA Cites Glenmark for Manufacturing Lapses

New Delhi, Jul 23 (PTI) The US health regulator has pulled up Glenmark Pharmaceuticals for manufacturing lapses, including failure to establish laboratory controls, at its Pithampur-based plant.

In a warning letter, the US Food and Drug Administration (USFDA) also pointed out the company's failure to follow an adequate written testing programme at the facility to assess stability characteristics of drug products.

The USFDA inspected the Pithampur, Madhya Pradesh-based manufacturing plant from February 3-14, 2025.

A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations.

"This warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals," it stated.

"Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated," it added.

Elaborating on the issues at the facility, USFDA stated that 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.


"Your firm failed to follow an adequate written testing program designed to assess the stability characteristics of drug products," it added.
The company failed to follow written stability procedure for finished drug products, it added.

"Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labelling, and drug products conform to appropriate standards of identity, strength, quality, and purity," USFDA noted.

USFDA stated that it has cited similar CGMP violations at the company's other facilities in Himachal Pradesh, Goa and the US, as well.

"These repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs is inadequate," USFDA said.

The US health regulator asked the drug firm to engage a consultant to assist in meeting CGMP requirements.

It further said, "Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP."

Failure to address any violations may also result in FDA continuing to refuse admission of articles manufactured at the plant, it added.