Latest news and insights on the pharmaceutical industry | Indian Pharma Post

Results For "US-FDA-inspection"

24 News Found

Alkem Laboratories receives 7 observations following US FDA inspection at Daman facility
Drug Approval | May 04, 2026

Alkem Laboratories receives 7 observations following US FDA inspection at Daman facility

The US regulator conducted an inspection at the Amaliya manufacturing plant between April 20 and May 1, 2026


Solara announces closure of US FDA inspection at Puducherry facility
Drug Approval | April 30, 2026

Solara announces closure of US FDA inspection at Puducherry facility

The Puducherry facility, dedicated to Ibuprofen and its derivatives, is equipped with advanced infrastructure to serve both domestic and international markets


US FDA inspection at Gland Pharma's Dundigal facility, Hyderabad
News | August 26, 2022

US FDA inspection at Gland Pharma's Dundigal facility, Hyderabad

The company has received 1 (ONE) observation on Form 483 with respect to ANDA filed for the product to be manufactured at the said Facility.


US FDA Inspection at Alkem's Indore manufacturing facility
Drug Approval | July 08, 2022

US FDA Inspection at Alkem's Indore manufacturing facility

This GMP and Pre-Approval Inspection is part of the routine business operations and the company shall submit to US FDA within the stipulated timeline


Saharsh Davuluri takes over as CEO & MD of Neuland  Laboratories
Appointment | April 02, 2026

Saharsh Davuluri takes over as CEO & MD of Neuland Laboratories

18-year veteran Saharsh will position the CDMO as a premier global API process development and commercial manufacturing specialist


Granules India’s facility secures FDA EIR with 'VAI’
Drug Approval | October 30, 2025

Granules India’s facility secures FDA EIR with 'VAI’

The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection conducted in June 2025


FDA prohibits Sun Pharma's Halol Plant from exporting drugs to US
Drug Approval | September 10, 2025

FDA prohibits Sun Pharma's Halol Plant from exporting drugs to US

Sun Pharma's Halol plant gets OAI classification from US FDA inspection


Granules India receives Form 483 with 1 observation from USFDA for Bonthapally API unit 1
Drug Approval | June 23, 2025

Granules India receives Form 483 with 1 observation from USFDA for Bonthapally API unit 1

Bonthapally facility is one of the world's largest single-site Paracetamol API manufacturing plants by volume


USFDA concludes inspection of NATCO’s  Pharma Division, Kothur
Drug Approval | June 20, 2025

USFDA concludes inspection of NATCO’s Pharma Division, Kothur

The company received seven observations in the Form-483