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About 816 results for "cgmp"

Making Ranbaxy units cGMP compliant time consuming: Sun Pharma
Money Control

Working on making plants global cGMP compliant: Sun Pharma

Drug major Sun Pharmaceutical Industries is working on making its manufacturing facilities compliant with good manufacturing norms and has asked the US health regulator to re-inspect its Halol plant. "We have undertaken a detailed remediation ... Business Standard, 1 week ago

44 images for cgmp

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Compliance Or Adherence? How To Approach cGMP Regulations In The 21st Century

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 Pharmaceutical Online5 days ago
Money Control

Pan Drugs Production Manager Fabricated Signatures, FDA Says in Warning Letter

Sept. 13, 2016 Pan Drugs, located in India, has received a warning letter due to a series of cGMP violations found during an inspection last year. The inspection revealed a failure to establish an adequate quality control unit, and the ...
 FDA News2 weeks ago USFDA warns Pan Drugs for violations of CGMP norms  Money Control2 weeks ago Unsafe Conditions at Vitalife, Website Claims Draw FDA Warning  FDA News2 weeks ago

CDSCO to recruit 500 drug inspectors to enhance cGMP compliance

The Central Drug Standards Control Organization (CDSCO) is planning to recruit 500 more drug inspectors in the coming one year going by its mandate to double the manpower by the end of 2017. Meanwhile CDSCO has already concluded the process of ...
 PharmaBiz3 weeks ago

USFDA issues warning letter to ex-Sun Pharma US facility

The USFDA has found significant violations of current good manufacturing practice (CGMP) norms at a plant in Philadelphia that was earlier owned by Sun Pharmaceutical and has issued a warning letter to its current owner, Frontida BioPharm. The ...
 Business Standard1 month ago

Lannett Says FDA Completes CGMP Inspections Of Three Facilities - Quick Facts

The inspections concluded with two minor 483 observations at the company's facility in Philadelphia and zero observations at the laboratories in Armenia. Arthur Bedrosian , chief executive officer of Lannett, said, "At a time of particularly ...
 Nasdaq1 week ago Lannett Announces Successful FDA Inspections of Three Facilities  CPhI.cn6 days ago Lannett announces US FDA completes cGMP inspection of its 3 manufacturing facilities  PharmaBiz1 week ago LANNETT : Announces Successful FDA Inspections of Three Facilities  4 Traders1 week ago

PCI Synthesis Obtains DEA Registration for Controlled Substance Dev't and Mnfg

Expands capabilities to handle cGMP development for schedule II, III, IV and V Related Breaking News PCI Synthesis, a drug substance contract manufacturing organization (CMO) of new chemical entities (NCEs) and generic active pharmaceutical ...
 Contract Pharma1 week ago PCI Synthesis Obtains Registration For Controlled Substance Development And Manufacturing  BioSpace1 week ago PCI SYNTHESIS : Obtains DEA Registration for Controlled Substance Development and Manufacturing  4 Traders1 week ago

FDC receives two observations from USFDA for Waluj plant

USFDA carried out the audit in relation to cGMP norms and the ANDA filed by the company for dorzolamide ophthalmic solution from the unit
 Business Standard2 months ago

WuXi Biologics completes construction of Asia s largest perfusion biologics manufacturing facility

ility accommodates two 1000L disposable bioreactors WuXi Biologics has opened its new commercial-scale cGMP biologics perfusion manufacturing facility in Wuxi city, China. In April 2015 the firm announced plans to build a $150 million ...
 Manufacturing Chemist1 day ago WuXi AppTec Completes First Phase Of $125 Million Biologics Manufacturing Facility  BioSpace4 days ago WuXi Biologics Opens Largest PerfusionBiologics Manufacturing Facility in Asia Using Disposable Bioreactors  Converter News4 days ago
Manufacturing Chemist

New FDA guidance on data integrity and cGMP compliance

In light of 21 CFR Part 11 violations related to the reliability and accuracy of dynamic electronic records, this article outlines the security and procedural controls needed to maintain unobscured and reliable analytical data throughout the
 Manufacturing Chemist1 day ago
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