Briefs: APL Healthcare, Biocon, USFDA, Sun Pharma and Clean Fino-Chem

USFDA determines Sun Pharma's Baska facility inspection classification as OAI

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

ImmunityBio’s ANKTIVA wins EMA nod for early EU approval in hard-to-treat bladder cancer

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

Clariant showcases VitiPure portfolio at CPHI India

VitiPure serves as essential solubilizers, emulsifiers, and bioavailability enhancers in drug formulations

Granules’ packaging facility in US completes FDA inspection with zero observations

Granules Consumer Health serves as Granules’ front-end division for OTC products in the US

Roche launches first rapid point-of-care test for whooping cough

The PCR-based test, delivered via Roche’s cobas liat system, allows results to be obtained during a patient consultation in GP practices and Emergency Rooms

Promotion of indigenous pharmaceutical manufacturing

PLI scheme for Bulk Drugs has a total budgetary outlay of Rs. 6,940 crore

SAI Parenteral's acquires Australia's Noumed Pharmaceuticals for Rs. 125 Cr

Ascendis Pharma’s FDA review of Achondroplasia drug gets 3-month delay

The FDA has classified recent submissions as a major amendment pushing the approval to its NDA for TransCon CNP back three months to February 28, 2026