Shilpa Medicare has received US Food and Drug Administration’s (USFDA) final approval for its ANDA, Zoledronic Acid Injection, 4 mg/5 mL on May 15, 2019. Zoledronic Acid Injection, 4 mg/5 mL is a generic equivalent of reference listed drug (RLD) Zometa.
It is a bisphosphonate indicated for the treatment of Hypercalcemia of malignancy, Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy as recommended in the label approved by USFDA.
According to IQVIA MAT Q1 2019 data, the US market for Zoledronic Acid Injection, 4 mg/5 mL is approximately $10.8 Million.
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. | 1529.55 |
Dr. Reddys Lab | 6315.00 |
Cipla | 1423.40 |
Zydus Lifesciences | 1021.00 |
Lupin | 1679.75 |
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