Drug Approval | May 12, 2025
Zydus receives final approval from USFDA for Glatiramer Acetate Injection
Glatiramer Acetate is the generic version of Copaxone 20 mg/ml, 40 mg/ml, Single-Dose Prefilled Syringes
Glatiramer Acetate is the generic version of Copaxone 20 mg/ml, 40 mg/ml, Single-Dose Prefilled Syringes
Lupin is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity
This Product is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension
Tolvaptan is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease
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
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