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Results For "compliance"

544 News Found

Lupin signs exclusive licensing pact with Neopharmed for Plasil in Philippines and Brazil
News | December 19, 2025

Lupin signs exclusive licensing pact with Neopharmed for Plasil in Philippines and Brazil

This agreement will enhance Lupin’s gastroenterology portfolio and expand its presence in emerging markets


SABIC launches first fluorine-free polycarbonate resin to boost medical device safety
Medical Device | December 19, 2025

SABIC launches first fluorine-free polycarbonate resin to boost medical device safety

The NP resin portfolio, indicated by its UL746G-certified prefix, equips manufacturers across industries to meet increasingly stringent regulatory and performance standards


Eli Lilly re-elects Nobel Laureate Carolyn Bertozzi to Board
People | December 17, 2025

Eli Lilly re-elects Nobel Laureate Carolyn Bertozzi to Board

Bertozzi currently serves as the Baker Family Director of Sarafan ChEM-H, Anne T. and Robert M. Bass Professor at Stanford University, and Investigator of the Howard Hughes Medical Institute


Lupin receives EIR from USFDA for Nagpur injectable facility
Drug Approval | December 17, 2025

Lupin receives EIR from USFDA for Nagpur injectable facility

The EIR was issued following an inspection of the facility from September 8 to September 16, 2025


FDA accepts Sentynl Therapeutics CUTX-101 NDA resubmission
Biopharma | December 16, 2025

FDA accepts Sentynl Therapeutics CUTX-101 NDA resubmission

If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease


Indoco receives EIR from the USFDA for its API manufacturing facility at Patalganga
News | December 15, 2025

Indoco receives EIR from the USFDA for its API manufacturing facility at Patalganga

Indoco received the Establishment Inspection Report from the USFDA for its API manufacturing facility


FDA completes inspection of SMS Pharma’s Vizag facility
Drug Approval | December 14, 2025

FDA completes inspection of SMS Pharma’s Vizag facility

The inspection concluded with one minor observation in Form 483


Granules Life Sciences facility receives EIR from USFDA
News | December 12, 2025

Granules Life Sciences facility receives EIR from USFDA

This approval confirms the facility's compliance with FDA quality standards and regulatory requirements


Shilpa Medicare receives initial authorization for Rotigotine transdermal patch from Europe
News | December 12, 2025

Shilpa Medicare receives initial authorization for Rotigotine transdermal patch from Europe

This is the first approval of a prescription transdermal dosage Form in the European markets from this facility


Only 4-5 Indian pharma companies have a strong presence in Russia but the opportunity is far bigger now: Manish Kumar, Vice-Chairman, Moscow Chamber of Commerce, Indian Commission; and President, Soltex Group
interviews | December 10, 2025

Only 4-5 Indian pharma companies have a strong presence in Russia but the opportunity is far bigger now: Manish Kumar, Vice-Chairman, Moscow Chamber of Commerce, Indian Commission; and President, Soltex Group

India has deep strengths in reverse engineering and API development, while Russia has strong capabilities in certain vaccines, biologicals, and niche therapeutic segments. Collaboration can significantly shorten R&D timelines