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Results For "Good-Manufacturing-Practice"

131 News Found

Lubrizol's polymer excipient Apisolex featured in Phase I candidate
News | June 11, 2025

Lubrizol's polymer excipient Apisolex featured in Phase I candidate

The use of Apisolex polymer excipient has been proven to increase the solubility of certain APIs by as much as 50,000-fold


Venus Remedies secures Ukrainian GMP renewal
News | May 23, 2025

Venus Remedies secures Ukrainian GMP renewal

Certification bolsters Venus Remedies' position in PIC/S markets, reinforcing commitment to global quality standards


Venus Remedies joins United Nations Global Compact
Sustainability | May 21, 2025

Venus Remedies joins United Nations Global Compact

This global affiliation marks a critical step in the company’s mission to create long-term value through ethical practices, scientific innovation, and inclusive healthcare delivery


Wanbury's Tanuku facility granted GMP certificate by ANVISA
Drug Approval | May 13, 2025

Wanbury's Tanuku facility granted GMP certificate by ANVISA

The inspection conducted from December 16, 2024 to December 20, 2024 by the Brazil Health Regulatory Agency (ANVISA)


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


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


Briefs: Ami Organics and Panacea Biotec
News | April 25, 2025

Briefs: Ami Organics and Panacea Biotec

Ami Organics’ Ankleshwar Unit II gets GMP compliant by PMDA Japan


OneSource secures GMP approval from Brazil for its flagship facility in Bengaluru
Drug Approval | April 11, 2025

OneSource secures GMP approval from Brazil for its flagship facility in Bengaluru

This approval marks a significant milestone in OneSource’s ongoing commitment to quality and regulatory compliance


OneSource Specialty Pharma updates on cGMP inspection by USFDA
Drug Approval | April 01, 2025

OneSource Specialty Pharma updates on cGMP inspection by USFDA

The inspection has concluded with four observations