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Shilpa Medicare gets USFDA’s nod for Erlotinib Tablets

06 Nov 2019 Evaluate

Shilpa Medicare has received the US Food and Drug Administration (USFDA) final approval for its ANDA, Erlotinib Tablets, 25 mg, 100 mg, and 150 mg on November 05, 2019.

Erlotinib Tablets, 25 mg, 100 mg, and 150 mg is a generic equivalent of reference listed drug (RLD) TARCEVA used in the treatment of patients with metastatic non-small cell lung cancer (NSCLC) and locally advanced, unresectable or metastatic pancreatic cancer as recommended in the label approved by USFDA.

According to IQVIA MAT Q2 2019 data, the US market for Erlotinib Tablets is approximately $172 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.

Peers
Company Name CMP
Sun Pharma. Inds. 1760.00
Dr. Reddys Labs. 1231.85
Cipla 1325.00
Lupin 1955.80
Zydus Lifesciences 1124.30
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