Gujarat based Espee Group gets USFDA approval for their manufacturing plant in USA

Gandhinagar: Aavis Pharmaceuticals, part of Espee Group, located in Hoschton, GA, completed an inspection by the US Food and Drug Administration at the company’s primary manufacturing facility with Zero 483 observations said company’s statement.

The statement added that: With successful inspection of its formulation manufacturing plant Espee becomes the 3rd Group in Gujarat to have USFDA approved plant in USA.

The company’s formulations facility was inspected by the USFDA for good manufacturing practices and PAI (Pre-Approval Inspection) in January 2019.

Aavis Pharma said it received the Establishment Inspection Report (EIR) in February 2019, which concludes the inspection process.

“It is a moment of great pride and a massive step forward towards the long-term strategy of our group and we congratulate the entire team at Aavis for successfully clearing its first inspection with zero 483 observation”, said Swapnil Shah, Executive Director of Espee Group and Ashok Barot, Chairman of Aavis Pharmaceuticals.

Closure of an inspection with zero observations is considered an achievement as a large number of inspections tend to generate one or two observations, which are subsequently addressed using mitigation measures.

Aavis is engaged in Contract Development and Manufacturing of Generic pharmaceuticals including controlled substances (Category II – V).
Espee Group with turnover of over $125 Million, has presence in more than 30 countries with locations in USA, UK, Canada, China, Australia, Japan & Brazil. Group has 3 Manufacturing Facilities (1 – Formulation facility in USA, 1 – API manufacturing in Vizag and 1 – Intermediates manufacturing in Hyderabad.)