Zydus Gets Nil Observations On USFDA Inspection, Receives Nod For Two Drugs
On Tuesday, Zydus Lifesciences in an exchange filing revealed that the group’s injectables manufacturing facility at Zydus Biotech Park in Changodar, Ahmedabad, underwent USFDA inspection from 05 June to 13 June 2023 with the cGMP inspection concluded with nil observations.
The company also received a final USFDA approval for two drugs on Tuesday to manufacture and market Diclofenac Sodium and Misoprostol Delayed-Release Tablets and Varenicline Tablets.
Diclofenac Sodium and Misoprostol delayed-release tablets are equivalent of US Reference Listed Drug (USRLD) Arthrotec Delayed-Release Tablets. Diclofenac belongs to nonsteroidal anti-inflammatory drug (NSAID) group of medicines. It works by reducing substances in the body that cause pain and inflammation.
Misoprostol reduces stomach acid and replaces protective substances in the stomach that are reduced by NSAIDs. Misoprostol protects the lining of the oesophagus, stomach and intestines while taking diclofenac. Diclofenac Sodium and Misoprostol Delayed-Release Tablets are used to treat osteoarthritis and rheumatoid arthritis in people at high risk for developing stomach or intestinal ulcers.
The drug will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad (India). Diclofenac Sodium and Misoprostol Delayed-Release Tablets had annual sales of USD 13 million in the United States (IQVIA MAT Mar. 2023).
Whereas Varenicline tablets are indicated to treat smoking addiction. The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India.
Dr Sharvil Patel, Managing Director, Zydus Lifesciences said, "We are pleased with the approval and imminent launch of generic Verinicline which validates the agility of our supply chain as well as the focused efforts by our R&D team which will improve access and availability of the generic product for patients in the US market. This an important product which will support our growth plans in US market in the current fiscal.”
Varenicline Tablets, 0.5 mg and 1 mg had annual sales of USD 501 million in the United States (IQVIA MAT Mar. 2023).
The company's stock was trading 0.04 per cent higher on Wednesday at Rs 517.90 per share as of 11:35 IST on BSE.
