Shilpa Medicare has received the approval for its second NDA (505(b)(2)), injectable product - Bortezomib Injection, from USFDA. Bortezomib Injection is approved for subcutaneous or intravenous use. It is available as a single dose vial of 3.5 mg/1.4 mL (2.5 mg/mL).
This is the first liquid injection for Bortezomib, approved for both subcutaneous and intravenous administration by the USFDA. The Injection is ‘ready to use’ for subcutaneous administration, offering significant advantages to the health care providers. The Injection has to be diluted for intravenous use. The reference product Velcade is a lyophilized injection which requires reconstitution prior to administration.
Bortezomib Injection, a proteasome inhibitor, contains bortezomib which is an antineoplastic agent. This NDA provides for the use of Bortezomib injection for the treatment of adult patients with multiple myeloma and for the treatment of adult patients with mantle cell lymphoma.
Shilpa Medicare produces and exports consistently high-quality Active Pharmaceutical Ingredients Fine Chemicals, intermediates, herbal products and speciality chemical products using sophisticated technology, meticulously following international specifications.
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1669.20 |
| Dr. Reddys Lab | 1233.50 |
| Cipla | 1232.25 |
| Zydus Lifesciences | 937.65 |
| Lupin | 2327.60 |
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