USFDA conducts inspection at Zydus Lifesciences Ahmedabad manufacturing facility

USFDA conducts inspection at Zydus Lifesciences Ahmedabad manufacturing facility

The inspection was a pre-approval inspection (PAI) and a GMP Audit that concluded with three observations.

FPJ Web DeskUpdated: Sunday, March 26, 2023, 10:34 AM IST
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USFDA conducts inspection at Zydus Lifesciences Ahmedabad manufacturing facility | Image: Zydus (Representative)

USFDA conducted an inspection at Zydus Lifesciences Limited's manufacturing facility SEZ-1 at Pharmez, Ahmedabad from March 20 to March 24, 2023, the company announced through an exchange filing. The inspection was a pre-approval inspection (PAI) and a GMP Audit that concluded with three observations.

The company said that there were no data integrity related observations and the company is addressing these observations.

Zydus received final approval from USFDA for Lubiprostone Capsules, the company announced on March 24.

Zydus Lifesciences shares

The shares of Zydus Lifesciences on Friday closed at Rs 480.05, down by 0.47 per cent.

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