Biopharmaceuticals Generics FDA

 News Release - March 27, 2020

Cipla Receives Final Approval for Generic Version of AstraZeneca Pharmaceutical's Nexium(R) (Esomeprazole for Oral Suspension 10mg, 20mg and 40mg)

Cipla is the first company to file for the 10mg strength

MUMBAI, India, March 27, 2020 -- (Healthcare Sales & Marketing Network) -- Cipla Limited (BSE: 500087) (NSE: CIPLA EQ) and hereafter referred to as "Cipla") today announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Esomeprazole for Oral Suspension 10mg, 20mg and 40mg from the United States Food and Drug Administration (US FDA). Cipla is the first company to file for the 10mg strength.

Cipla's Esomeprazole for Oral Suspension 10mg, 20mg and 40mg is AB-rated generic therapeutic equivalent version of AstraZeneca Pharmaceutical's Nexium®. It is a proton pump inhibitor indicated for the following:

• Treatment of gastroesophageal reflux disease (GERD).
• Risk reduction of NSAID-associated gastric ulcer.
• H. pylori eradication to reduce the risk of duodenal ulcer recurrence.
• Pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

According to IQVIA (IMS Health), Nexium® and its generic equivalents had US sales of approximately $70M for the 12-month period ending November 2019.

The product is available for shipping immediately.

About Cipla

Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in our home markets of India, South Africa, North America, and key regulated and emerging markets. Our strengths in the respiratory, anti-retroviral, urology, cardiology, anti-infective and CNS segments are well-known. Our 46 manufacturing sites around the world produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to our 80+ markets. Cipla is ranked 3rd largest in pharma in India (IQVIA MAT Dec'19), 3rd largest in the pharma private market in South Africa (IQVIA MAT Dec'19), and is among the most dispensed generic players in the U.S. For over eight decades, making a difference to patients has inspired every aspect of Cipla's work. Our paradigm-changing offer of a triple anti-retroviral therapy in HIV/AIDS at less than a dollar a day in Africa in 2001 is widely acknowledged as having contributed to bringing inclusiveness, accessibility and affordability to the centre of the HIV movement. A responsible corporate citizen, Cipla's humanitarian approach to healthcare in pursuit of its purpose of 'Caring for Life' and deep-rooted community links wherever it is present make it a partner of choice to global health bodies, peers and all stakeholders. For more, please visit www.cipla.com .

Source: Cipla

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