Drug Approval | August 11, 2025
Shilpa Medicare receives approval of NorUDCA tablets for treatment of NAFLD in India
NorUDCA is the first?in?class treatment for Non?alcoholic Fatty Liver Disease (NAFLD) in India
NorUDCA is the first?in?class treatment for Non?alcoholic Fatty Liver Disease (NAFLD) in India
This facility is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms
This was a full GMP inspection of the entire facility with specific focus on Ondansetron Oral Film drug product
Orion will be the exclusive partner for the distribution, marketing, and sales of Shilpa's Recombinant Human Albumin in Europe
The company has posted net profit of Rs. 82.62 crores for the Financial Year ended March 31, 2025
Lupin is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity
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)
Both units of Shilpa Medicare (Unit IV and Unit VII), have now received GMP approval from Eurasia
The company has received the GMP Certification after successful closure of the inspection
IMKELDI is an advanced liquid formulation of imatinib designed to provide dosing accuracy
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