Zydus Lifesciences gets 6 observations from USFDA, share gain

There were no Data Integrity related observations and no repeat observations from the previous inspection, company said.

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The share price of Zydus Lifesciences edged up in early trade on December 26 after the company received six observations without any repeats from the United States Food and Drug Administration (USFDA).

At 9:29am, Zydus Lifesciences was quoting Rs 682.00, up Rs 2.05, or 0.30 percent, on the BSE.

The USFDA conducted an inspection at the API site situated at Changodar, Ahmedabad. This PAI-cum-GMP USFDA inspection was conducted from December 14 to 22 and closed with six observations, the company said.

There were no data integrity-related observations and no repeat observations from the previous inspection, it added.

There are four drug master files of this site under approval with the USFDA and the company will work closely with the USFDA to address the observations.

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The company last week received the final approval from the USFDA to manufacture and market Lacosamide Tablets USP, 50 mg, 100 mg, 150 mg, and 200 mg, used to treat partial-onset seizures and also with other medicines to treat primary generalized tonic-clonic seizures.

Earlier this month, the company received the final approval from the USFDA for the manufacturing and marketing of Methylene Blue Injection, available in 10mg/2ml and 50mg/5ml variants.

Methylene Blue Injection is an oxidation-reduction agent used for treating pediatric and adult patients with acquired methemoglobinemia.