U.S. FDA Identifies Quality, Testing Issues At Zydus Lifesciences’ Gujarat Injectable Facility

The U.S. drug regulator has identified quality and testing issues at Zydus Lifesciences Ltd.’s injectable facility in Jarod, Gujarat.

The U.S. Food and Drug Administration inspected the company’s facility from Feb. 24 to March 10. At the end of the inspection, three observations are issued, the drugmaker had said in a March 10 exchange filing without disclosing details.

BloombergQuint has obtained a copy of these observations from the U.S. FDA through Freedom of Information Act.

Observation 1

The company has failed to complete testing within predefined time frame. There was a failure to test 250 stability sample injectables within the required days.

Observation 2

The company has failed to follow the written procedures for quality evaluations conducted annually to review approval and rejection records of representative commercial drug batches.

Observation 3

The buildings used for manufacturing and processing of products are not maintained in a good state of repair.

The regulator has retracted the names of the injectable drug products that failed testing and quality evaluations but said the site primarily manufactured for the U.S. markets.

Some of the injectables for which the facility had received approval in the past include Glycopyrrolate (a pre-surgery injection to decrease secretions from mouth, lungs and stomach), Doxycycline (used to treat or prevent bacterial infections, including pneumonia and other respiratory tract infections), and Haloperidol Decanoate injection (for schizophrenia). It’s, however, unclear which products are specifically impacted.

The company, in the exchange filing, said it was confident of addressing and resolving the issues to the satisfaction of the U.S. FDA. “We remain committed to building a quality culture across our entire manufacturing network, and are committed to remain compliant with high standards of good manufacturing practices across our network.”

Shares of Zydus Lifesciences have risen 3.95% since March 10. The stock was trading 1.07% higher as of 1 p.m. on Wednesday compared with a 1.46% rise in the Nifty 50.

The observations are benign, according to two analysts from domestic brokerages.

The company should be able to receive an establishment inspection report (inspection closure report) soon with a voluntary action indicated status, one of the analysts told BloombergQuint on the condition of anonymity as he is not authorised to speak with the media.

A VAI status means the FDA will not recommend regulatory or enforcement action because the objectionable conditions do not meet the threshold for action.

The plant, he said, was last inspected in 2018 and hence the inspection was long due. The observations are more procedural. While it is difficult to arrive at exact contribution of the plant to the top line, it is one of the important facilities for future growth as the company is increasingly focusing on injectables, he said.

According to the second analyst quoted above, the issue is expected to be resolved in the next six months.

BloombergQuint’s emailed queries to the company remain unanswered.