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Results For "Good-Manufacturing-Practices"

79 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


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)


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


Briefs: Emcure and Relonchem
Drug Approval | February 27, 2025

Briefs: Emcure and Relonchem

USFDA inspection at Emcure Pharmaceuticals API facility


Briefs: Syngene International and Cipla
Drug Approval | February 23, 2025

Briefs: Syngene International and Cipla

Cipla Limited has received final approval from the USFDA for the New Drug Application submitted for ‘Nilotinib Capsules 50, 150 and 200 mg’