Dr Reddy's Labs API Mirfield facility gets 7 USFDA observations

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-09-06 09:22 GMT   |   Update On 2025-09-06 09:22 GMT
Advertisement

Hyderabad: Dr Reddy's Labs has announced that the company has received seven observations from the United States Food & Drug Administration (USFDA) for the API Mirfield facility in West Yorkshire, UK.

The GMP inspection was conducted from September 1 to September 5, 2025.

"We have been issued a Form 483 with 7 observations, which we will address within the stipulated timeline," the company stated in a BSE filing.
Advertisement

An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

Read also: Dr Reddy's Secures CDSCO Panel Approval to Import, Market Olutasidenib for AML

Established in 1984, Dr. Reddy’s Laboratories Ltd. is a global pharmaceutical company headquartered in Hyderabad, India. The Company offers a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Its major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr Reddy's Labs major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe.

Read also: Dr Reddy's Gets CDSCO Panel Approval To Begin Phase III Trial of Tapinarof Cream


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