CIPLA LTD S/GDR 144A - CPLFY STOCK NEWS

Cipla has launched Leuprolide Acetate Injection Depot 22.5mg, approved by the US FDA via the 505(b)(2) regulatory pathway. This product is vital for the palliative treatment of advanced prostate cancer and is provided as a single-dose injection for 3-month administration. Cipla aims to enhance access to affordable treatments, aligning with their growth strategy in complex products. Previous sales of LUPRON DEPOT® 22.5mg from Abbvie reached approximately $197M in the year up to September 2022.

Cipla Limited has received final approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsules available in 5 mg, 10 mg, 15 mg, and 25 mg strengths. This approval allows Cipla to market a generic version of Revlimid®, which generated approximately $2.58 billion in US sales for the 12 months ending June 2022. Lenalidomide is indicated for various hematological malignancies in adults, though it has specific contraindications, particularly for pregnant women. The product is expected to be shipped soon.

Cipla Limited will participate in the 40th Annual J.P. Morgan Healthcare Conference on January 12, 2021. Mr. Umang Vohra, MD and Global CEO, will provide a corporate overview highlighting the company's performance and strategic priorities. The presentation is set for 19:30 IST and will also be available later on Cipla's website. Established in 1935, Cipla specializes in pharmaceuticals, focusing on sustainable growth and a diverse product portfolio across major global markets.

Cipla has received final approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Difluprednate Ophthalmic Emulsion 0.05%, a generic version of Novartis' Durezol®. This product is indicated for treating inflammation and pain due to ocular surgery and endogenous anterior uveitis. Durezol® had US sales of approximately $106 million for the 12 months ending June 2021. Cipla plans to ship the product soon, reinforcing its commitment to expanding its portfolio in key markets.

Cipla Limited announced receiving final approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Arformoterol Tartrate Inhalation Solution 15 mcg / 2 mL. This generic version is therapeutically equivalent to Sunovion Pharmaceuticals' Brovana, which had US sales of approximately $438M in the past year. The product is available for immediate shipping, enhancing Cipla's presence in the respiratory market and potentially contributing to revenue growth. Cipla remains a significant player in India and South Africa, focusing on sustainable growth and complex generics.

Cipla Therapeutics has partnered with SIGA Technologies to tackle antimicrobial resistance (AMR) and improve access to novel antibacterial drugs, particularly for biothreats. This strategic alliance aims to support the Biomedical Advanced Research and Development Authority (BARDA) in addressing public health challenges. With SIGA's expertise and Cipla's manufacturing capabilities, they plan to leverage Cipla's antibiotic ZEMDRI® to enhance health security initiatives. This partnership highlights the urgency of combating AMR, a critical global health threat recognized by the WHO.

Cipla Limited has received final approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) for the 20 mg Sumatriptan Nasal Spray. This product is a generic version of GlaxoSmithKline's Imitrex® Nasal Spray, indicated for the acute treatment of migraines in adults. According to IQVIA, the U.S. sales of Imitrex Nasal Spray and its generics reached approximately $53.3 million in the year ending December 2020. Cipla aims to leverage this approval to expand its presence in the migraine treatment market.

Cipla Limited (BSE: 500087; NSE: CIPLA EQ) announced on September 28, 2020, that it has received final FDA approval for its Abbreviated New Drug Application (ANDA) for Dimethyl Fumarate DR Capsules in 120mg and 240mg doses. This product is a generic version of Biogen IDEC's Tecfidera®, which saw US sales of approximately $3.8 billion in the 12 months ending July 2020. The generic drug is indicated for treating relapsing forms of multiple sclerosis and is available for shipping immediately, supported by Co-Pay Assistance.