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Results For "US-FDA"

344 News Found

Sun Pharmaceutical Q1 FY26 consolidated PAT falls by 20% to Rs. 2,278 Cr
News | August 02, 2025

Sun Pharmaceutical Q1 FY26 consolidated PAT falls by 20% to Rs. 2,278 Cr

India Formulation sales accounted for 34.2% of total consolidated sales for the quarter


Panacea Biotec reaches settlement with Apotex
News | July 12, 2025

Panacea Biotec reaches settlement with Apotex

Apotex will also pay US$ 2.5 million upon receipt of final USFDA approval of the ANDA that is the subject of the Collaboration Agreement for Paclitaxel Protein-Bound Particles for Injectable Suspension


Briefs: Neuland Laboratories and Granules India
Drug Approval | June 29, 2025

Briefs: Neuland Laboratories and Granules India

Granules India receives 1 observation from USFDA for Chantilly facility


Briefs: J B Chemicals and Pharmaceuticals, Concord Biotech and Gland Pharma
Drug Approval | June 25, 2025

Briefs: J B Chemicals and Pharmaceuticals, Concord Biotech and Gland Pharma

J B Chemicals and Pharmaceuticals receives ANDA approval for Amitriptyline Hydrochloride Tablets from USFDA


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


Briefs: Hikal and Sun Pharma
Drug Approval | June 17, 2025

Briefs: Hikal and Sun Pharma

Sun Pharma gets 8 observations from USFDA for Halol facility


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


Zydus receives EIR for the API manufacturing facility at Ankleshwar and Dabhasa
Drug Approval | June 12, 2025

Zydus receives EIR for the API manufacturing facility at Ankleshwar and Dabhasa

Zydus receives EIR for the API manufacturing facility at Ankleshwar


Granules India posts Q4 FY25 PAT at Rs. 152 Cr
News | May 28, 2025

Granules India posts Q4 FY25 PAT at Rs. 152 Cr

The company reported sustained increase in formulations' share despite slowdown in productivity of Gagillapur facility