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

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

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

Eiko LifeSciences to acquire 51% stake in SSM Formulations

The plant can reach an annual capacity of 300 crore tablets and 90 crore capsules

FDA completes inspection of SMS Pharma’s Vizag facility

The inspection concluded with one minor observation in Form 483

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

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

Zydus receives EIR for the injectable facility located at Jarod

This inspection was conducted following the warning letter issued by the USFDA

Sudapack breaks ground on major PharmaGuard expansion in Erolzheim

Phase one of the expansion will convert an existing hall into an ISO 7-certified cleanroom for GMP-compliant production

Exyte completes Pharmaplan integration

Pharmaplan brings a pan-European footprint of locations and specialist teams, now operating within Exyte’s Biopharma & Life Sciences division

NATCO Pharma receives 7 observations from USFDA for API unit at Manali