Shares of Zydus Lifesciences Ltd. ended flat after hitting a day’s high of Rs 1,070.50 on 11th October, despite the firm announcing yesterday that it has received final approval from the United States Food and Drug Administration (USFDA) to manufacture paliperidone extended-release tablets in 1.5 mg, 3 mg, 6 mg, and 9 mg doses.

Paliperidone extended-release tablets are used for the acute and maintenance treatment of schizophrenia, as well as for the acute treatment of schizoaffective disorder, both as monotherapy and in combination with mood stabilisers and antidepressants.

These tablets will be manufactured at Zydus Lifesciences’ facility in the Special Economic Zone (SEZ), Ahmedabad. According to IQVIA MAT July 2024 data, annual sales of paliperidone extended-release tablets in the United States reached $47.1 million.

Last week, the company announced that it had received an Establishment Inspection Report (EIR) from the USFDA following an inspection conducted in July 2024.

The USFDA inspected the company’s transdermal patch manufacturing facility in Pharmez, Ahmedabad, from 15th to 19th July 2024, and has classified it as ‘voluntary action indicated’ (VAI) after issuing an Establishment Inspection Report (EIR).

In August, the FDA issued a warning letter to the company’s drug manufacturing facility in Jarod, Gujarat, citing inadequate Current Good Manufacturing Practices (CGMP). The inspection in April 2024 revealed issues related to cross-contamination, particulate contamination, and poor aseptic procedures.

As of 30th June 2024, the company has received 400 approvals and has filed over 465 ANDAs (Abbreviated New Drug Applications) since starting the filing process in FY 2003-04.

At 3:30 PM, the shares of Zydus Lifesciences closed 0.74% higher at Rs 1,064.80 on NSE.

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