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Results For "regulated-markets"

139 News Found

BDR plans to enter the regulated markets this year: Raheel Shah, Director, BDR Group of Companies
interviews | February 15, 2022

BDR plans to enter the regulated markets this year: Raheel Shah, Director, BDR Group of Companies

BDR Pharmaceuticals is a home-grown company with operations in India and overseas. It’s known for its formulations portfolio and has a presence in specialty medicines. The company has ambitious plans as it has ramped up capacity and looking to foray into regulated markets. Raheel Shah, Director, BDR Group of Companies shares his insights in an interview with Thomas C Thottathil, Editor, Indian Pharma Post


Gujarat Themis Biosyn to acquire anti-TB and anti-infective brands from Sanofi for EUR 158 Million
News | April 24, 2026

Gujarat Themis Biosyn to acquire anti-TB and anti-infective brands from Sanofi for EUR 158 Million

Deal includes 13 branded generic products across 55+ countries; acquisition expected to strengthen global anti-infective portfolio and expand regulated market presence


Supriya Lifescience receives USFDA EIR with VAI classification for Maharashtra API facility
News | April 22, 2026

Supriya Lifescience receives USFDA EIR with VAI classification for Maharashtra API facility

Inspection outcome reinforces company's compliance track record and strengthens its ability to serve regulated markets including the United States


Aurobindo Pharma bags USFDA nod for Glycerol Phenylbutyrate Oral Liquid
Drug Approval | April 20, 2026

Aurobindo Pharma bags USFDA nod for Glycerol Phenylbutyrate Oral Liquid

The approved product is a generic version of Ravicti, originally developed and marketed by Horizon Therapeutics


Rusan Pharma secures Japan PMDA GMP approval for API, FDF facilities
News | April 20, 2026

Rusan Pharma secures Japan PMDA GMP approval for API, FDF facilities

PMDA is regarded among the most stringent regulatory bodies globally


Morepen Laboratories secures fourth consecutive USFDA ‘NIL 483’ inspection
Drug Approval | April 17, 2026

Morepen Laboratories secures fourth consecutive USFDA ‘NIL 483’ inspection

Zero-observation outcomes strengthen global credibility and accelerate CDMO ambitions


Unichem’s US arm recalls Buspirone tablets after stability test OOS result
News | April 13, 2026

Unichem’s US arm recalls Buspirone tablets after stability test OOS result

No adverse events reported; recall involves 5 mg 500-count bottles in the US market


HRV Pharma, Shodhana join hands to build next-gen API pipeline for global markets
News | April 07, 2026

HRV Pharma, Shodhana join hands to build next-gen API pipeline for global markets

Multi-year CDMO partnership combines AI-led virtual development, precision chemistry and GMP manufacturing to accelerate five high-science APIs across regulated markets


Alembic Pharma wins USFDA nod for generic Dapagliflozin, secures 180-day exclusivity
Drug Approval | April 07, 2026

Alembic Pharma wins USFDA nod for generic Dapagliflozin, secures 180-day exclusivity

Final approval for diabetes and heart-failure drug opens access to a $10.5 billion US market opportunity, with shared exclusivity benefits.


Molbio’s digital radiology arm secures CE MDR certification for its medical imaging portfolio
Medical Device | April 02, 2026

Molbio’s digital radiology arm secures CE MDR certification for its medical imaging portfolio

Certification by TÜV SÜD Product Service GmbH reinforces the company's commitment to globally benchmarked standards in safety, quality, and performance