The share price of Cipla Ltd rallied 5% on 11 April after the company announced securing approval from the US Food and Drug Administration (USFDA) for its cancer drug.
In its regulatory filing, the company said that the USFDA approved the Abbreviated New Drug Application (ANDA) for Paclitaxel Protein-bound Particles for Injectable Suspension (albumin-bound), 100 mg/vial, Single-Dose Vial (also called “Protein-bound Paclitaxel”) on 10 April 2025.
In an exchange filing, Cipla, said, “We hereby notify that the company has received final approval from the United States Food and Drug Administration (USFDA) for the Abbreviated New Drug Application (ANDA) submitted for Paclitaxel Protein-bound Particles for Injectable Suspension (albumin-bound), 100 mg/vial, Single-Dose Vial (‘Protein-bound Paclitaxel’) on 10 April, 2025.”
Nonetheless, the product is expected to debut in the United States in the first half of fiscal year 2025-2026.
Paclitaxel is prescribed for the treatment of metastatic breast cancer, metastatic pancreatic adenocarcinoma, and locally advanced or metastatic non-small cell lung cancer (NSCLC). Furthermore, Cipla’s Protein-bound Paclitaxel is an AB-rated generic medication that is equal to Bristol Myers Squibb’s Abraxane® for Injectable Suspension 100 mg/vial.
Cipla is a worldwide pharmaceutical firm with over 80 years of experience dedicated to making quality healthcare available to everyone.
With operations in more than 80 nations, the company is renowned for its wide range of pharmaceutical products, which include more than 1,500 products in several therapeutic areas.
The company is a respiratory care leader, has produced unique drug-device combinations, and has had a significant global impact with its pioneering work in HIV/AIDS treatment, particularly by decreasing the cost and boosting access to triple antiretrovirals in Africa.
Cipla is still committed to accessibility and cost, particularly in developing regions like Africa and India where it is well-established.
At 11:38 am, the shares of Cipla were trading 2.61% higher at Rs 1,452.60 on NSE.
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