Espee Group’s US arm gets USFDA nod for Hoschton facility

Our Bureau | Updated on February 26, 2019 Published on February 26, 2019

To operate as a CDMO offering generic drug products in the US market

Ahmedabad, Feb 26 Aavis Pharmaceuticals, an arm of Gujarat-based Espee Group has received US Food and Drug Administration’s (USFDA) clearance for its facility in Hoschton, Georgia (US) with 'Zero 483 observations.'

The company has already commissioned the facility and plans to serve as a Contract Development and Manufacturing Organisation (CDMO) offering a variety of pharmaceutical development and manufacturing solutions as an integrated service provider.

"With successful inspection of its formulation manufacturing plant, Espee becomes among the top Groups from Gujarat to have USFDA approved plant in the USA. The company’s formulations facility was inspected by the USFDA for good manufacturing practices and PAI (Pre-Approval Inspection) in January 2019. The company received the Establishment Inspection Report (EIR) in February 2019, which concludes the inspection process," the company informed.

Aavis, having 45 per cent stake from Espee Group, is engaged CDMO activity for Generic pharmaceuticals including controlled substances (Category II – V) and looks to be an innovator and generic drug maker for the world market.

"We had invested about US $ 25-28 million for the plant. We look to bring our first commercial product in April this year. The plant will have the capacity to make 1.2 million tablets per batch with a total capacity to make about 250 batches per year," said Swapnil Shah, Executive Director, Espee Group.

He further added that the company is also looking to achieve a sizeable market share in the existing US $ 45-million market for molecules. "Our first year revenue target for this operations is US $ 40 million for 2019," said Shah.

The Espee Group has an overall revenues of over $125 mn with presence in more than 30 countries with locations in USA, UK, Canada, China, Australia, Japan & Brazil. About 15 per cent of the revenues come from India business, which includes two API manufacturing facilities in Visakhapatnam and one intermediates facility in Hyderabad.

"Currently, we have used our internal accruals to meet the immediate funding requirements. However, we will look for other options to raise funds as and when a possibility arises," added Shah.

Published on February 26, 2019
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