Dr Reddys Labs: USFDA closes warning letter for three sites

In November 2015, Dr Reddy's had said it had received a warning letter from the US Food and Drug Administration (USFDA) for three of its sites -- active pharmaceutical ingredient (API) manufacturing facilities at Srikakulum, Andhra Pradesh, and Miryalguda, Telengana, and Oncology formulation manufacturing facility at Duvadda, Visakhapatnam, Andhra Pradesh.

Published On 2020-08-30 04:45 GMT   |   Update On 2022-12-08 05:47 GMT

New Delhi: Drug firm Dr Reddy's Laboratories on Friday said the US health regulator Food has "closed" warning letter issued for three of its sites in Andhra Pradesh and Telangana, following evaluation of corrective actions taken by the company.

In November 2015, the company said it had received a warning letter from the US Food and Drug Administration (USFDA) for three of its sites -- active pharmaceutical ingredient (API) manufacturing facilities at Srikakulum, Andhra Pradesh, and Miryalguda, Telengana, and Oncology formulation manufacturing facility at Duvadda, Visakhapatnam, Andhra Pradesh.

"...We have now been informed by the USFDA that based on its evaluation, we have addressed the violations and deviations contained in the said warning letter. With this, the said warning letter has been closed," Dr Reddy's Laboratories said in a regulatory filing.

Read also: Dr Reddys Launches Generic Version Of Cuprimine Capsules In US

Tags:    
Article Source : PTI

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