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 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 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

Shilpa Medicare Bio Analytical unit gets "No Action Indicated" classification from USFDA

This Unit of Shilpa Medicare is engaged in testing biological samples of clinical studies

Shilpa Medicare launches Pemetrexed injection

Pemetrexed Injection is used as a drug, in the treatment of non-small cell lung cancer in combination with other chemotherapy agents