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8889 News Found

Unichem receives Form 483 from USFDA with 3 observations for Roha API facility
Drug Approval | June 23, 2025

Unichem receives Form 483 from USFDA with 3 observations for Roha API facility

The company will provide the necessary response to USFDA within stipulated 15 days


BASF opens new GMP Solution Center in US
News | June 23, 2025

BASF opens new GMP Solution Center in US

BASF strengthens its commitment to the biopharma and pharmaceutical ingredients industries through a new investment in North America


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


Emcure to acquire remaining stake in Zuventus Healthcare
News | June 23, 2025

Emcure to acquire remaining stake in Zuventus Healthcare

The transaction is expected to close in Q2 FY 2026


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


Sanner commences manufacturing critical injection-molded components in USA
Packaging | June 20, 2025

Sanner commences manufacturing critical injection-molded components in USA

The GMP-compliant facility with automated environmental monitoring accommodates both white room and class 7 and 8 cleanroom space


USFDA inspection at the API manufacturing plant located in Mekaguda, Hyderabad
Drug Approval | June 17, 2025

USFDA inspection at the API manufacturing plant located in Mekaguda, Hyderabad

The company received one observation in the Form-483


USFDA conducts GCP inspection at Syngene's facility at Semicon Park, Bengaluru
Drug Approval | June 17, 2025

USFDA conducts GCP inspection at Syngene's facility at Semicon Park, Bengaluru

The inspection concluded successfully, with the facility found to be in compliance with the required regulations


Novo Nordisk to advance subcutaneous and oral amycretin for weight management into phase 3 clinical development
News | June 16, 2025

Novo Nordisk to advance subcutaneous and oral amycretin for weight management into phase 3 clinical development

The decision to advance subcutaneous and oral amycretin into phase 3 is based on feedback received from regulatory authorities