Sun Pharma gets FDA approval for ganirelix acetate and plans to acquire Japan’s Pola Pharma

Generics/News | Posted 25/01/2019 post-comment0 Post your comment

Sun Pharmaceutical Industries (Sun Pharma), one of India’s largest pharmaceutical company, marks the start of 2019 with two exciting new developments.

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Sun Pharma has received final approval from the US Food and Drug Administration (FDA) on its abbreviated new drug application (ANDA) for its generic version of Organon’s ganirelix acetate injection, 250 mcg/0.5 mL. The active ingredient, ganirelix, is a gonadotrophin-releasing hormone antagonist. It is used in combination with follicle stimulating hormone in assisted reproduction, and works by inhibiting premature luteinizing hormone surges in women undergoing controlled ovarian hyperstimulation.

Late in 2018, Sun Pharma announced its plans to acquire the Japanese pharmaceutical company Pola Pharma Inc, part of the POLA ORBIS Group for US$1 million. Sun Pharma will acquire Pola Pharma’s drug portfolio, which includes branded and generic drug products with a strong dermatology focus, as well as its manufacturing facilities and research and development capabilities. Pola Pharma’s two manufacturing sites in Saitama, Japan, have capabilities to produce topical products and injectables.

Sun Pharma is the leader in the generic dermatology segment in the US, and this move is aligned with the company's plans to expand its global dermatology business. ‘Pola Pharma is a leading dermatology company and it will help us to launch our speciality and generic dermatology products in the Japanese market in future’, said Kirti Ganorkar, Executive Vice President of Sun Pharm, ‘We also get access to local manufacturing capability enabling us to serve the Japanese pharmaceutical market more effectively’.

This move comes two years after Sun Pharma entered the Japanese market with the acquisition of 14 prescription brands from Novartis.

Sun Pharma will reap the financial benefits of the approval of its generic ganirelix acetate injection when it is launched in US markets, which is expected to be at the end of 2019. IQVIA reported annual sales of ganirelix acetate injection of approximately US$67 million in the US for the 12 months ending in September 2018. The acquisition of Pola Pharma is expected to be completed before the end of January 2019.

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