Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 8

Results For "compliance"

403 News Found

USFDA classifies Biocon Biologics Johor Bahru site, Malaysia as VAI
Drug Approval | January 13, 2025

USFDA classifies Biocon Biologics Johor Bahru site, Malaysia as VAI

Biocon Biologics remains committed to global standards of quality and compliance


ZIM Laboratories and Neuraxpharm granted marketing authorization for Buprenorphine Sublingual Film in Europe
News | January 10, 2025

ZIM Laboratories and Neuraxpharm granted marketing authorization for Buprenorphine Sublingual Film in Europe

According to IQVIA, the European market for Buprenorphine-based opioid dependency treatments in 2023 surpassed USD 355 million annually


Windlas Biotech’s new injectable facility receives GMP certification
News | January 10, 2025

Windlas Biotech’s new injectable facility receives GMP certification

The certification marks a new chapter in Windlas Biotech’s growth trajectory,


Carbogen Amcis successfully completed Swissmedic inspection of its Vionnaz facility
News | January 10, 2025

Carbogen Amcis successfully completed Swissmedic inspection of its Vionnaz facility

The site’s GMP Certification has been successfully renewed


Lupin receives EIR from USFDA for Pithampur Unit-1 Facility with VAI Classification
Drug Approval | January 09, 2025

Lupin receives EIR from USFDA for Pithampur Unit-1 Facility with VAI Classification

The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection of the facility from September 16 to September 27, 2024


Caplin Point receives EIR from FDA with Zero 483 observations
Drug Approval | January 07, 2025

Caplin Point receives EIR from FDA with Zero 483 observations

The inspection, which is a routine part of the FDA's regulatory oversight, evaluates compliance with Good Manufacturing Practices and other regulatory requirements.


Nutraceuticals CDMO manufacturer Crius Group to adopt 100% AI-based project implementation
Digitisation | January 07, 2025

Nutraceuticals CDMO manufacturer Crius Group to adopt 100% AI-based project implementation

NutrifyGenie AI, a leading AI-driven platform, was integral in designing scientifically differentiated formulations for a multinational client


CDSCO approves Wockhardt’s Mignaf for treatment of community acquired bacterial pneumonia
Drug Approval | January 05, 2025

CDSCO approves Wockhardt’s Mignaf for treatment of community acquired bacterial pneumonia

Wockhardt plans to launch Miqnaf in the Indian market in coming few months


Aarti Drugs receives EIR from USFDA for Tarapur API facility
Drug Approval | December 26, 2024

Aarti Drugs receives EIR from USFDA for Tarapur API facility

This facility is considered to be in a minimally acceptable state of compliance with regard to current GMP


ANVISA inspection received from Brazil Health Regulatory Agency at Wanbury Tanuku facility
Drug Approval | December 21, 2024

ANVISA inspection received from Brazil Health Regulatory Agency at Wanbury Tanuku facility

The company will receive GMP compliance certificate which will further help to accelerate the business growth across the globe