Alembic Pharma gets one procedural observation for Vadodara facility

Published On 2025-03-07 12:13 GMT | Update On 2025-03-07 12:13 GMT

Vadodara: Alembic Pharma has announced that the United States Food and Drug Administration (USFDA) has concluded an inspection with one procedural observation at the Company's Bioequivalence Facility located at Vadodara.

The inspection was conducted from 3rd March, 2025 to 7th March, 2025.

This was a scheduled inspection. The USFDA issued a Form 483 with one procedural observation.

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.

"The Company will provide comprehensive response to USFDA for the observations within the stipulated period. The Company is committed to maintain the highest quality standards and compliance at all times," Alembic stated in a filing.

Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.

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.

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

Comments Policy

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 .

Alembic Pharma gets one procedural observation for Vadodara facility

Similar News

Bayer Canada partners with Mint Pharma for distribution of ADALAT XL 30 mg tablets in Canada

AstraZeneca Koselugo recommended for approval in EU for plexiform neurofibromas in adults with neurofibromatosis type 1

AbbVie submits new drug application to USFDA for Tavapadon for Parkinsons disease

Patna Shocker: Pharma Representative Brutally Murdered, Probe Underway

Delhi ITAT Deletes Rs 14.98 Cr Ad-Hoc Disallowance on Mankind Pharma's Travel Expenses

Delhi Govt Bans Genetic Sample Transfers, Tightens Abortion Pill Sales to Curb Sex-Selective Practices

CDSCO Panel Recommends Updating Prescribing Information for Sanofi's Vaccine

Eli Lilly Kisunla gets marketing authorization from European Commission for early symptomatic Alzheimer's disease