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Results For "US"

8006 News Found

SMS Pharmaceuticals completes USFDA inspection at Central Laboratory Analytical Services
Drug Approval | June 27, 2025

SMS Pharmaceuticals completes USFDA inspection at Central Laboratory Analytical Services

The inspection concluded with zero Form 483 observations


Lupin receives USFDA approval for Prucalopride Tablets
Drug Approval | June 25, 2025

Lupin receives USFDA approval for Prucalopride Tablets

Prucalopride Tablets are indicated for the treatment of chronic idiopathic constipation in adults


Datroway approved in the US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer
News | June 24, 2025

Datroway approved in the US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer

First and only TROP2-directed therapy approved in the US for the treatment of lung cancer


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