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USFDA issues 3 observations for Zydus Lifesciences Ahmedabad facility

The inspection was a Pre-Approval Inspection as well as a GMP Audit.

By - Ruchika Sharma
Published On 2023-03-27 08:45 GMT   |   Update On 2023-03-27 12:46 GMT

Ahmedabad: Drug major, Zydus Lifesciences, has recently announced that the US Food and Drug Administration (USFDA) has concluded an inspection with three observations at the company's manufacturing facility SEZ-1 located at Pharmez, Ahmedabad.The inspection was held from March 20 to 24, 2023."The inspection was a Pre-Approval Inspection (PAI) as well as a GMP Audit and concluded with...

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Ahmedabad: Drug major, Zydus Lifesciences, has recently announced that the US Food and Drug Administration (USFDA) has concluded an inspection with three observations at the company's manufacturing facility SEZ-1 located at Pharmez, Ahmedabad.

The inspection was held from March 20 to 24, 2023.

"The inspection was a Pre-Approval Inspection (PAI) as well as a GMP Audit and concluded with three observations. There were no Data Integrity related observations," the company said in a BSE filing.
Read also: Zydus Lifesciences wins USFDA approval for Lubiprostone Capsules to treat constipation
"The Company is addressing these observations and will respond to them within the stipulated time," Zydus added.
Medical Dialogues team had earlier reported that USFDA had concluded a Pre-Approval Inspection (PAI) with two observations at the SEZ, Ahmedabad facility of Zydus Animal Health and Investments Limited, a wholly owned subsidiary of Zydus Lifesciences Limited.
Read also: USFDA issues 2 observations for Zydus Lifesciences arm Ahmedabad facility
Zydus Lifesciences Limited, Formerly known as Cadila Healthcare Limited, is an Indian Pharmaceutical company headquartered in Ahmedabad. The company was founded in the year 1952 by Mr. Ramanbhai B. Patel (late), a first-generation entrepreneur and a doyen in the field of Indian Pharmaceuticals. It is primarily engaged in the manufacture of generic drugs.

Read also: Zydus Lifesciences Depression drug Doxepin Hydrochloride bags USFDA okay

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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