USFDA issues EIR for Alkem Laboratories’ Baddi facility

31 Jul 2019 Evaluate

The US Food and Drug Administration (USFDA) has issued an Establishment Inspection Report (EIR) for Alkem Laboratories’ manufacturing facility located at Baddi, which was inspected from May 13, 2019 to May 17, 2019. The inspection has now been closed by the USFDA. In response to the Form 483 issued by the USFDA containing four observations, the company had submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines.

Alkem Laboratories is a leading Indian pharmaceutical company with global operations, engaged in the development, manufacture and sale of pharmaceutical and nutraceutical products. The company produces branded generics, generic drugs, active pharmaceutical Ingredients (APIs) and nutraceuticals, which it markets in India and International markets.

Alkem Laboratories Share Price

4903.15 31.75 (0.65%)
26-Apr-2024 16:01 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1504.25
Dr. Reddys Lab 6263.70
Cipla 1406.25
Zydus Lifesciences 948.20
Lupin 1615.85
View more..
© 2024 The Alchemists Ark Pvt. Ltd. All rights reserved. MoneyWorks4Me ® is a registered trademark of The Alchemists Ark Pvt.Ltd.