Aavis Pharmaceuticals — an arm of Gujarat-based Espee Group — on Tuesday announced that it has received clearance from the US Food and Drug Administration (USFDA), for its facility in Hoschton, Georgia, with ‘Zero 483 observations’.
The company, which has already commissioned the facility, plans to serve as a Contract Development and Manufacturing Organisation (CDMO), offering a variety of pharmaceutical development and manufacturing solutions .
“With the successful inspection of its formulation manufacturing plant, Espee has become one of the top groups from Gujarat to have a USFDA-approved plant in the US. 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 said.
Production from April
As a CDMO, Aavis is engaged in manufacturing generic pharmaceuticals including controlled substances (Category II-V) and looks to be an innovator and generic drug maker for the global market.
“We invested about $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 garner a sizeable market share in the existing $45-million market for molecules. “Our first-year revenue target for this operations is $40 million for 2019,” said Shah.
The Espee Group has total revenues of over $125 million, with presence in more than 30 countries with facilities in the US, UK, Canada, China, Australia, Japan and Brazil. About 15 per cent of the revenues come from the India business, which includes two API manufacturing facilities in Visakhapatnam and one intermediate facility in Hyderabad.
“We have used our internal accruals to meet the immediate funding requirements. We will look for other options to raise funds as and when a possibility arises,” added Shah.