Alembic Pharma Receives USFDA EIR for Karakhadi Injectable Facility
New Delhi: Alembic Pharmaceuticals has announced that it has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its injectable manufacturing facility located at Karakhadi, Gujarat.
The company said the EIR was issued for its Injectable Facility (F-III) on May 13, 2026, following a USFDA inspection conducted between February 9 and February 18, 2026.
The receipt of an EIR indicates the successful closure of the inspection process by the US health regulator. The inspection was carried out at Alembic Pharmaceuticals’ injectable manufacturing unit situated at Karakhadi.
According to the company’s regulatory filing, the update follows its earlier disclosure made in February regarding the USFDA inspection at the facility.
Alembic Pharmaceuticals informed the stock exchanges that it has requested the authorities to take the development on record.
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.