Shilpa Medicare receives US approval for Varenicline Tablets, 0.5 mg and 1 mg

Shilpa’s product has been approved as a generic version to the innovator - Chantix Tablets, 0.5 mg and 1 mg, of PF Prism C.V. (PF Prism)

Shilpa Medicare's Unit IV receives Eurasia GMP approval

Both units of Shilpa Medicare (Unit IV and Unit VII), have now received GMP approval from Eurasia

Shilpa Medicare’s Unit VII, Nacharam, Hyderabad receives GMP certificate from EMA, Austria

The company has received the GMP Certification after successful closure of the inspection

Shilpa Medicare’s JV Oncosol gets USFDA approval for IMKELDI

IMKELDI is an advanced liquid formulation of imatinib designed to provide dosing accuracy

Shilpa Medicare Q2 FY25 consolidated PAT up 1,008% at Rs. 18 Cr

Shilpa Medicare’s acceptance by USFDA of NDA filed by its CDMO partner Unicycive for Oxylanthanum Carbonate

USFDA inspection of Shilpa Medicare Unit VI at Bengaluru

The inspection concluded with the issuance of Form 483 with four observations which are procedural in nature

Shilpa Medicare’s CDMO customer gets fast-track designation for its investigational drug candidate

GBM affects nearly 13,000 patients annually in the US and approximately 300,000 globally

Shilpa Medicare receives USFDA approval for Bortezomib injection

Bortezomib Injection is approved for subcutaneous or intravenous use. It is available as a single dose vial of 3.5 mg/1.4 mL (2.5 mg/mL)

Shilpa Medicare announces positive outcome of Phase 3 studies of NorUDCA

Nor UDCA is likely to be a first-in-class treatment option for NAFLD in India