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Results For "ANDA"

2088 News Found

Jagsonpal Pharmaceuticals posts Q4 FY25 PAT at Rs. 6.58 Cr
News | May 12, 2025

Jagsonpal Pharmaceuticals posts Q4 FY25 PAT at Rs. 6.58 Cr

The company has posted net profit of Rs. 55.36 crores for the Financial Year ended March 31, 2025


Zydus receives final approval from USFDA for Glatiramer Acetate Injection
Drug Approval | May 12, 2025

Zydus receives final approval from USFDA for Glatiramer Acetate Injection

Glatiramer Acetate is the generic version of Copaxone 20 mg/ml, 40 mg/ml, Single-Dose Prefilled Syringes


Lupin launches Eslicarbazepine Acetate tablets in US
Drug Approval | May 08, 2025

Lupin launches Eslicarbazepine Acetate tablets in US

Lupin is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity


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


AstraZeneca's enhertu improved pCR in early-stage breast cancer
News | May 07, 2025

AstraZeneca's enhertu improved pCR in early-stage breast cancer

AstraZeneca and Daiichi Sankyo’s Enhertu followed by THP showed an improved safety profile vs. standard of care


Innoxel Lifesciences completes USFDA inspection
Drug Approval | May 06, 2025

Innoxel Lifesciences completes USFDA inspection

This outcome reflects Innoxel Lifesciences' ongoing commitment to maintaining the highest standards of quality, compliance, and regulatory excellence


Europe (AGES, Austria) inspects Shilpa Biologicals’ Dharwad site
Drug Approval | May 06, 2025

Europe (AGES, Austria) inspects Shilpa Biologicals’ Dharwad site

he inspection covering the sterile drug product filling and packaging line, quality systems and quality control laboratories concluded compliance with the principles and guidelines of Good Manufacturing Practice


Vanta Bioscience receives GLP compliance re-certification
News | May 03, 2025

Vanta Bioscience receives GLP compliance re-certification

This recertification of Company's OECD GLP is testimony to company's unwavering commitment to maintain international quality standards at the facility


RPG Life Sciences posts Q4 FY25 net profit at Rs. 117.35 Cr
News | May 03, 2025

RPG Life Sciences posts Q4 FY25 net profit at Rs. 117.35 Cr

RPG Life Sciences has reported total income of Rs. 148.15 crores during the period ended March 31, 2025


Thyrocare launches diagnostic lab in Bhagalpur
Healthcare | May 03, 2025

Thyrocare launches diagnostic lab in Bhagalpur

30th Lab in Thyrocare’s expanding network to bring advanced, affordable diagnostics in Bihar and beyond