“Shilpa Medicare Limited formulation division has received U.S Food and Drug Administration final approval for its ANDA, Docetaxel Injection USP, 20 mg/mL, 80 mg/4 mL (20 mg/mL), and 160 mg/8 mL (20 mg/mL) on 16.05.2019. Docetaxel Injection USP, 20 mg/mL, 80 mg/4 mL and 160 mg/8 mL is a generic equivalent of reference listed drug (RLD) TAXOTERE used in the treatment of Breast Cancer, Non-Small Cell Lung Cancer, Prostate Cancer, Gastric Adenocarcinoma, Head and Neck Cancer as recommended in the label approved by FDA.”
Shilpa Medicare Ltd formulation division has also received U.S Food and Drug Administration final approval for its ANDA, Zoledronic Acid Injection, 4 mg/5 mL on 15.05.2019. 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 FDA.
About Shilpa Medicare Limited Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.