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 Pharma Lifesciences receives CEP from EDQM for API, Desmopressin

This is used to treat central diabetes insipidus and bedwetting

Shilpa Biologicals appoints Dr. Sridevi Khambhampaty as CEO

She brings an overall Techno Commercial experience of 22+ Years in various Organizations

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

Shilpa Pharma Lifesciences received CEP from EDQM for ursodeoxycholic acid

Ursodeoxycholic acid or ursodiol is a naturally occurring bile acid that is used dissolve cholesterol gall stones

Shilpa Biologicals receives registration approval for Adalimumab from Morocco, MoH

Shilpa Biologicals has developed high concentration adalimumab (100 mg/mL)

Shilpa Pharma Lifesciences’ Unit 2 Raichur has cleared the ANVISA-Brazil GMP inspection

The Unit has been issued GMP Certification from ANVISA-Brazil

Shilpa's CDMO customer placed binding purchase order