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
The CEP certification for Metformin Hydrochloride aligns with the company's strategy to penetrate stringently regulated markets
AstraZeneca and Daiichi Sankyo’s Enhertu followed by THP showed an improved safety profile vs. standard of care
he inspection covering the sterile drug product filling and packaging line, quality systems and quality control laboratories concluded compliance with the principles and guidelines of Good Manufacturing Practice
Tatva Chintan Pharma Chem receives export order worth $35, 55,000
IGI recently completed the dose-escalation portion of its Phase 1 clinical study in patients with heavily pretreated multiple myeloma
Topiramate is indicated as a treatment of epilepsy and migraine
This outcome reflects Innoxel Lifesciences' ongoing commitment to maintaining the highest standards of quality, compliance, and regulatory excellence
The transaction enhances Roquette’s ability to deliver high-value drug delivery solutions to pharmaceutical customers worldwide
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