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USFDA inspection at Concord Biotech’s API facility at Dholka
Drug Approval | May 03, 2025

USFDA inspection at Concord Biotech’s API facility at Dholka

These observations are procedural in nature and none of them are related to data integrity


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


Neuland Laboratories completes USFDA inspection at Unit 2
Drug Approval | May 03, 2025

Neuland Laboratories completes USFDA inspection at Unit 2

The FDA issued Form 483 with one observation related to building and facility management


Sanofi Consumer Healthcare India Q1 PAT up 12.9%
News | May 03, 2025

Sanofi Consumer Healthcare India Q1 PAT up 12.9%

The Q1 2025 also witnessed a successful launch of Allegra D


Zydus receives final approval from USFDA for Niacin Extended-Release Tablets USP
Drug Approval | May 02, 2025

Zydus receives final approval from USFDA for Niacin Extended-Release Tablets USP

Niacin is indicated to reduce elevated total cholesterol, LDL cholesterol, apolipoprotein B and triglycerides (TG)


Vimta Labs posts Q4 FY25 PAT at Rs. 18.31 Cr
News | May 01, 2025

Vimta Labs posts Q4 FY25 PAT at Rs. 18.31 Cr

Vimta Labs has reported total income of Rs. 96.08 crores during the period ended March 31, 2025


Sigachi Industries signs MoU with Respilon Group
News | May 01, 2025

Sigachi Industries signs MoU with Respilon Group

This partnership marks a significant milestone in Sigachi's strategy to expand into advanced drug delivery technologies.


USFDA inspects Marksans’s subsidiary Time-Cap Laboratories' manufacturing facility
Drug Approval | May 01, 2025

USFDA inspects Marksans’s subsidiary Time-Cap Laboratories' manufacturing facility

The Subsidiary has received one inspectional observation in Form 483


Strides receives USFDA approval for anti-inflammatory Celecoxib Capsules
Drug Approval | May 01, 2025

Strides receives USFDA approval for anti-inflammatory Celecoxib Capsules

Celecoxib Capsules approval complements Strides’ existing products to serve a broader patient base


CHMP recommends EU label update for Roche’s Phesgo to allow administration outside of clinical settings
Clinical Trials | May 01, 2025

CHMP recommends EU label update for Roche’s Phesgo to allow administration outside of clinical settings

Phesgo label expansion delivers on patients’ preference for at-home administration and is an important step in freeing up cancer care capacity in clinical settings