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kilitch healthcare: USFDA issues warning letter to Kilitch Healthcare for Navi-Mumbai plant

The US Food and Drug Administration (USFDA) has issued a warning letter to Kilitch Healthcare India for manufacturing lapses at its plant in Maharashtra. The letter highlights various violations of current good manufacturing practice (CGMP) regulations, including packing drugs in insanitary conditions and failing to establish proper procedures to prevent contamination. The USFDA observed that the facility was poorly cleaned and maintained, posing risks of contamination. Kilitch Healthcare has committed to suspending production of all drugs for the US market. The company must address the violations and provide a plan for corrective action.

Mumbai , Maharashtra , India , Paresh-mehta , Drug-administration , Kilitch-healthcare-india , Managing-director-paresh-mehta , Kilitch-healthcare , Usfda , Cgmp , Us-food-and-drug-administration , Fda

Successful biopharma production and quality control

Kaneka Eurogentec produce biopharmaceutical critical raw materials with quality control

Belgium , Kaneka-eurogentec , Agilent-technologies , Case-study , Cgmp , Uality-control , Iomolecules , Iopharma ,

USFDA issues warning letter to Intas over 'quality lapses'

India Business News: US FDA issues warning letter to Intas for violations at Ahmedabad facility, citing lapses in CGMP regulations. The letter highlights identity, strengt

Ahmedabad , Gujarat , India , Drug-administration , Current-good-manufacturing-practice , Federal-food , Cosmetic-act , Business-news , Usfda , Intas , Fda

usfda: USFDA issues warning letter to Intas Pharma for Sanand plant

Intas Pharmaceuticals has been criticised by the USFDA for multiple manufacturing faults, including deficiencies in its quality control systems at its Sanand-based manufacturing plant. The US health regulator issued a warning letter saying the faults mean the company's drug products are adulterated.

Sanand , Gujarat , India , Drug-administration , Intas-pharmaceuticals , Intas-pharma-warning-letter , Cgmp , Usfda , Us-food-and-drug-administration ,

Top 10 cGMP violations for FY22 | Natural Products INSIDER

A deep dive into FDA regulations intended to ensure dietary supplement products are made to quality standards.

Appropriations-committee , Importers-program , Consumer-healthcare-products-association , Information-act , Foreign-supplier-verification-programs , Voluntary-qualified-importers-program , Cgmp ,

USFDA pulls up Sun Pharma for lapses in Halol plant

USFDA pulls up Sun Pharma for lapses in Halol plant

Mumbai , Maharashtra , India , Gujarat , Halol , Sun-pharma , Drug-administration , Sun-pharmaceutical-industries-ltd , Current-good-manufacturing-practice , Sun-pharmaceutical-industries , Usfda- , Alol-plant

MAHE sets up Centre for cGMP - The Hindu BusinessLine

MAHE sets up Centre for cGMP
March 10, 2021
A view of the administrative block of the Manipal Academy of Higher Education (MAHE) in Manipal. - The Hindu
A view of the administrative block of the Manipal Academy of Higher Education (MAHE) in Manipal. - The Hindu×
Manipal Academy of Higher Education (MAHE) has established a Centre for current Good Manufacturing Practices (cGMP) at Manipal College of Pharmaceutical Sciences in Manipal.
Quoting Girish Pai Kulyadi, coordinator of the centre, in a media release said, “There is a huge industry-academia gap with respect to GMP concepts in academic curriculum and actual industry practice, and therefore academia has a major role to inculcate a strong GMP foundation in young brains.”

Manipal , Karnataka , India , Girish-thunga , Ravindrau-shenoy , Harishk-jain , Vasudevr-pai , Girish-pai-kulyadi , Arvind-pai , Embiotic-laboratoriesp-ltd , Pharmqa-compliance-services , Manipal-academy-of-higher-education

CS Analytical Laboratory Announces Formation of New C&C Solutions Group

CS Analytical Laboratory Announces Formation of New C&C Solutions Group
PRWeb
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CLIFTON, N.J. (PRWEB) February 24, 2021
CS Analytical Laboratory, the world’s only cGMP, FDA-registered and inspected contract laboratory exclusively designed and dedicated to container testing for the pharmaceutical, biotechnology, and medical device industries, officially announced today the formation of a new service unit: Comprehensive & Complementary (C&C) Solutions to offer clients unique services and custom-built qualification testing packages to address specific client challenges in a comprehensive manner. C&C Services include those analytical capabilities that Complement CS Analytical’s standard compendial test offerings or tie together numerous compendial and non-compendial methods to provide a Comprehensive solution to a given challenge.

Brian-mulhall , C-solutions , C-services , Complementarycc-solutions , Cs-analyticalcc-solutions , Cs-analytical-team , Cs-analytical-advisory-services , Cs-analytical-laboratory , Laboratory-announces-formation , Newcc-solutions , Advisory-services , Camp