Drug Approval | July 17, 2025
Shilpa Medicare receives EIR from USFDA for Unit VI, Bengaluru
This facility is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms
This facility is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms
The audit has been concluded with no major observations
Orion will be the exclusive partner for the distribution, marketing, and sales of Shilpa's Recombinant Human Albumin in Europe
Shilpa Pharma Lifesciences, Unit-1, received EIR from USFDA
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)
This program aims to develop a fully human monoclonal antibody against a novel immune checkpoint protein that enables T cell activation
Teriflunomide is a novel disease-modifying agent that was approved for use in the treatment of multiple sclerosis
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
Octreotide is synthetic peptide manufactured by Shilpa Pharma Lifesciences through solid phase synthesis
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