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Results For "USFDA"

1355 News Found

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


Sun Pharma to raise stake in US-based Pharmazz to 22.7%
Biopharma | May 24, 2025

Sun Pharma to raise stake in US-based Pharmazz to 22.7%

Sun Pharma will invest up to $25 million in US-based Pharmazz Inc, raising its stake to 22.7%


Briefs: Dr. Reddy's Laboratories, Relonchem,  Shilpa Pharma Lifesciences and Shanmuga Hospital
News | May 18, 2025

Briefs: Dr. Reddy's Laboratories, Relonchem, Shilpa Pharma Lifesciences and Shanmuga Hospital

Shilpa Pharma Lifesciences, Unit-1, received EIR from USFDA


Remedium Lifecare secures Rs. 182.7 crore export deal
News | May 16, 2025

Remedium Lifecare secures Rs. 182.7 crore export deal

The CDMO upgrade represents a transformational step for Remedium Lifecare


Briefs: Zydus and CuraTeQ Biologics
Drug Approval | May 14, 2025

Briefs: Zydus and CuraTeQ Biologics

CuraTeQ Biologics receives approval for biosimilar Zefylti from UK’s MHRA


Lupin launches Tolvaptan Tablets in the US with 180-day exclusivity
News | May 13, 2025

Lupin launches Tolvaptan Tablets in the US with 180-day exclusivity

Tolvaptan Tablets are indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease


Sigachi Industries receives CEP for Metformin Hydrochloride from EDQM
News | May 08, 2025

Sigachi Industries receives CEP for Metformin Hydrochloride from EDQM

The CEP certification for Metformin Hydrochloride aligns with the company's strategy to penetrate stringently regulated markets


Senores Pharmaceuticals acquires ANDA for Topiramate HCl 25, 50, 100 and 200 mg tablets
News | May 06, 2025

Senores Pharmaceuticals acquires ANDA for Topiramate HCl 25, 50, 100 and 200 mg tablets

Topiramate is indicated as a treatment of epilepsy and migraine