Zydus gets USFDA EIR for Ankleshwar API facility

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-06-12 06:24 GMT   |   Update On 2025-06-12 06:24 GMT
Advertisement

AhmedabadZydus has announced that the company has received the Establishment Inspection Report (EIR) report from the US Food and Drugs Administration (US FDA) for the inspection conducted at its API manufacturing facility located at Ankleshwar.

This facility underwent an inspection from 10th to 14th March 2025, and the inspection has been classified as No Action Indicated (NAI). NAI means no objectionable conditions or practices were found during the inspection.

Advertisement

The USFDA has concluded that this inspection is “closed”. 

Read also: Zydus Lifesciences venture capital arm to acquire stake in Agenus for USD 16 million

Zydus Lifesciences Ltd. is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs 27,000 people worldwide, including 1,400 scientists engaged in R & D. Over the last decade, Zydus has introduced several innovative, first-in-class products in the market for treating unmet healthcare needs with vaccines, therapeutics, biologicals and biosimilars.

Read also: Zydus Lifesciences to acquire India, Sri Lanka rights for Agenus cancer immunotherapy BOT/BAL


Tags:    

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News