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