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Zydus' largest formulations unit in Moraiya gets EIR from the USFDA

Zydus' largest formulations unit in Moraiya gets EIR from the USFDA

Zydus' largest formulations unit in Moraiya gets EIR from the USFDA
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By CNBCTV18.com Nov 7, 2022 3:35:46 PM IST (Published)

Moraiya facility is the company’s largest formulations manufacturing unit.

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Zydus Lifesciences Ltd. has received an establishment inspection report (EIR) from the United States Food and Drug Administration (USFDA) for its formulations manufacturing unit at Moraiya, near Ahmedabad in Gujarat.


The USFDA classified the inspection as a Voluntary Action Indicated (VAI). The facility was inspected between July 26 - August 5 and concluded with four observations. The inspection has now been declared closed.

Moraiya facility is the company’s largest formulations manufacturing unit and it was issued a Warning Letter in November 2019 by USFDA.  An approval with Voluntary Action Indicated (VAI) means objectionable conditions or practices were found at the manufacturing unit but USFDA does not recommend any administrative or regulatory action.

The EIR nod from USFDA for the Moraiya plant could pave the way for more approvals from the US drug regulator for a higher number of transdermal products and some limited competition products from Zydus Lifesciences in the coming months.

Zydus Lifesciences, the Ahmedabad headquartered company, develops, manufactures, and markets a broad range of healthcare therapies. The Zydus group has research facilities across Gujarat, Maharashtra, Goa, Himachal Pradesh, and Sikkim. It also has manufacturing and research units in the US and Brazil.

Shares of Zydus ended 2.4 percent higher at Rs 450.4.
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