In the US, the compassionate use approvals are provided by FDA in the form of individual patient-specific expanded-access IND
According to IQVIATM sales data for the 12-month period ending October 2024, the Vimpat Oral Solution, 10 mg/mL market achieved annual sales of approximately $57.0 million
Final decision from the European Commission is anticipated within the coming months
The successful completion of RRA assessment by the USFDA, would enable company to open up its business in the USA market
This product is indicated in coagulation disorders caused by vitamin K deficiency or interference with vitamin K activity.
The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Xalatan
The first and only immuno-oncology drug approved for the treatment of nasopharyngeal carcinoma
Glenmark's Travoprost Ophthalmic Solution USP, 0.004% is bioequivalent and therapeutically equivalent to the reference listed drug, Travatan Z Ophthalmic Solution USP, 0.004% of Sandoz
Jagsonpal Pharmaceuticals has received full consideration of Rs. 41 crore towards the sale of the facility and will now be proceeding with registration formalities
Bumetanide Injection USP (RLD Bumex) had an estimated annual sale of USD 20 million in the US
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