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Lupin Bioresearch Centre completes fifth successful US-FDA inspection

Lupin Bioresearch Centre (LBC) conducts the in-vivo and in-vitro bioequivalence studies for Lupin in Pune...................

C-CAMP hosts US FDA workshop for start-ups & innovators addressing anti...

The Centre for Cellular and Molecular Platforms (C-CAMP) organized a one-day workshop on ‘US FDA Regulatory Approval Process for Anti-microbials’ on 6th March 2019 at C-CAMP, Bengaluru....................

India’s Translumina becomes first company in the world to present 10-year...

Translumina Therapeutics achieved a special feat of becoming the first company in the world to demonstrate a 10-year patient safety and efficacy data of its drug eluting stent, Yukon Choice PC............

Indian medical device firms be given faster access to US-FDA: study

Indian medical device industry is worth over Rs 60,000 crore even as country’s import bill for this segment amounts to over Rs 23,000 crore while exports amount to about Rs 7,000 crore, as per the study by ASSOCHAM and MRSS India...………..

Popular antibiotic used in India for infections could be hazardous

The fluoroquinolones class of antibiotics that are commonly used to treat illnesses such as respiratory and urinary tract infections have been red flagged by the USFDA but are still available in hundreds of generic forms in India...…………...

Biocon receives EIR from USFDA for its Bengaluru facility

The US Food and Drug Administration (USFDA) has sent the report citing closure of inspection of Biocon's sterile drug product manufacturing facility in Bengaluru............

US FDA approves Mylan & Biocon’s biosimilar, Fulphila

Second FDA-approved biosimilar through the Mylan-Biocon collaboration,, Fulphila is expected to be the first biosimilar pegfilgrastim available in the U.S. to help patients with nonmyeloid cancers reduce the risk of infection...............

Metropolis Healthcare & NACO come together under PPP for HIV Viral...

Through this game-changing initiative by the government, NACO and Metropolis will together impact lives of lakhs of patients. All tests to be conducted at the Metropolis Global Reference Laboratory located in Kurla, Mumbai and other Metropolis Labs............

Sanat’s manufacturing unit in Sikandrabad undergoes successful USFDA inspection

The USFDA team thoroughly reviewed Sanat products’s herbal extract manufacturing, quality control, and quality assurance procedures during an inspection that was carried out during December 2017.............

USFDA approves Mylan & Biocon´s biosimilar for breast, gastric cancers

Mylan anticipates potentially being the first company to provide patient access to a biosimilar to Herceptin, representing a significant milestone for Mylan, Biocon and the overall healthcare system........