Launch of 2nd NDA Bortezomib for injection3.5mg/1.4ml in US
SHILPAMED · price
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Awaiting price reaction for this filing.
Shilpa Medicare has received USFDA approval and is launching its second NDA (New Drug Application) for Bortezomib injection at the 3.5mg/1.4ml strength in the US market. Bortezomib is a key chemotherapy drug used to treat multiple myeloma and mantle cell lymphoma. This is the company's second approved Bortezomib product, strengthening its oncology injectable portfolio in the world's largest pharmaceutical market. The launch positions Shilpa to capture additional share in a high-value, niche oncology segment with limited generic competition.
Positive for the stock — a new product launch in the US, a hard-currency export market, broadens the company's approved oncology range and supports future revenue growth from its CDMO/finished dosage business.