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Dear Readers, Welcome to the latest issue of Micro
Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as “Cipla”) and its wholly owned subsidiary Cipla USA Inc., (hereafter referred to as “Cipla”), today announced that Cipla Limited has received U.S. Food and Drug Administration (FDA) approval for its Abbreviated New Drug Application (ANDA) for Generic Advair Diskus® (fluticasone propionate and salmeterol inhalation powder) in all three strengths – 100/50 mcg, 250/50 mcg, and 500/50 mcg.
The product is a therapeutically equivalent version of Advair Diskus®, a widely prescribed combination therapy indicated for the treatment of asthma and chronic obstructive pulmonary disease (COPD). According to IQVIA, the U.S. market for fluticasone propionate and salmeterol inhalation powder is approximately $908 million. This approval represents Cipla’s first dry powder inhaler (DPI) approval from its U.S.-based manufacturing network, marking a significant milestone in the company’s continued expansion of complex respiratory capabilities in the United States.
Commenting on the approval, Achin Gupta, Managing Director & Global CEO, Cipla Limited, said, “At Cipla, we are passionate about respiratory care given our long-standing expertise. This approval reinforces our commitment to expanding access to complex therapies in the U.S. and highlights our strength in developing and scaling sophisticated inhalation products through integrated capabilities.”Marc Falkin, Chief Executive Officer – North America, Cipla Limited, added, “This approval marks our first dry powder inhaler from our New York facility and reflects our targeted investments in building differentiated inhalation manufacturing capabilities in the U.S. It strengthens our ability to provide reliable, high-quality supply in an important and competitive category.”
Commenting on the approval, Achin Gupta, Managing Director & Global CEO, Cipla Limited, said, “At Cipla, we are passionate about respiratory care given our long-standing expertise. This approval reinforces our commitment to expanding access to complex therapies in the U.S. and highlights our strength in developing and scaling sophisticated inhalation products through integrated capabilities.”
Marc Falkin, Chief Executive Officer – North America, Cipla Limited, added, “This approval marks our first dry powder inhaler from our New York facility and reflects our targeted investments in building differentiated inhalation manufacturing capabilities in the U.S. It strengthens our ability to provide reliable, high-quality supply in an important and competitive category.”
Backed by Cipla’s vertically integrated inhalation platform, the product reflects the company’s commitment to strengthening U.S. manufacturing capabilities for complex respiratory treatments.
