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Results For "Good-Manufacturing-Practices"

75 News Found

Venus Remedies awarded Saudi GMP approval for all its production facilities in Baddi
Drug Approval | February 28, 2023

Venus Remedies awarded Saudi GMP approval for all its production facilities in Baddi

The company expects the GMP approval from Saudi Food and Drug Authority (SFDA) to soon pave the way for marketing authorizations from the largest market in the GCC region


Briefs: Neuland Laboratories, Cipla and Zydus
Drug Approval | February 20, 2023

Briefs: Neuland Laboratories, Cipla and Zydus

Cipla has received 8 inspectional observations in Form 483


NIB is playing a vital role in ensuring that quality biological products reach the health system: Dr. Mandaviya
Policy | January 29, 2023

NIB is playing a vital role in ensuring that quality biological products reach the health system: Dr. Mandaviya

It will help upgrade the infrastructure and technologies of the country's biopharmaceuticals and in-vitro diagnostic industry


USFDA conducts PAI and GMP inspection of Piramal Pharma's Sellersville facility
Drug Approval | January 16, 2023

USFDA conducts PAI and GMP inspection of Piramal Pharma's Sellersville facility

The company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations


USFDA inspects Piramal Pharma Lexington facility
Drug Approval | January 12, 2023

USFDA inspects Piramal Pharma Lexington facility

The company is preparing a detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines.


CDSCO and State Drugs Control Administration commence joint inspection of drug manufacturing units
Policy | December 28, 2022

CDSCO and State Drugs Control Administration commence joint inspection of drug manufacturing units

A committee of two Joint Drugs Controllers has been constituted at CDSCO to monitor the process of inspection, reporting, and subsequent action to ensure compliance to the Drugs & Cosmetics Act, 1940


Biocon Biologics insulins facility in Malaysia receives EU GMP Certification
News | October 26, 2022

Biocon Biologics insulins facility in Malaysia receives EU GMP Certification

The company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.


PIB: Quality control of Ayush drugs
Policy | August 03, 2022

PIB: Quality control of Ayush drugs


Sun gets 10 observations from USFDA for Halol facility
News | May 10, 2022

Sun gets 10 observations from USFDA for Halol facility

The company is preparing the response to the observations, which will be submitted to the USFDA within 15 business days


GMP certification for Exothera further extends its viral vector manufacturing capacity
Biotech | March 23, 2022

GMP certification for Exothera further extends its viral vector manufacturing capacity

The expansion makes Exothera one of the largest viral vector facilities in Europe