Drug Approval | April 24, 2025
Caplin Steriles gets USFDA approval for Phytonadione Injectable Emulsion
Phytonadione Injectable Emulsion possesses the same type and degree of activity as does naturally-occurring vitamin K
Phytonadione Injectable Emulsion possesses the same type and degree of activity as does naturally-occurring vitamin K
The company delivered revenues of Rs. 5,554 crore, representing 10% growth in FY25
SmartTrack aims to reduce the need for clinical studies in generic drug product approvals
The EIR was issued following an inspection of the facility conducted from June 10 to June 13, 2024
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Protein-bound Paclitaxel is indicated for the treatment of metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer and metastatic adenocarcinoma of the pancreas
This approval marks a significant milestone in OneSource’s ongoing commitment to quality and regulatory compliance
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)
Raichur site is the group’s largest API facility and part of a wider network of seven sites
NATCO has decided to price the product at Rs.15, 900 MRP consistent with the company’s stand before the court
The company expects to launch this product through its marketing partner in the near future
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