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. With successful inspection of its formulation manufacturing plant Espee becomes the 3rd Group in Gujarat to have USFDA approved plant in USA.
|Swapnil Shah – Executive Director, Espee Group|
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 observations,” said Swapnil Shah, Executive Director of Espee Group and Ashok Barot, Chairman of Aavis Pharmaceuticals.
He added that, “AAVIS Pharmaceuticals is one of the fastest growing pharmaceutical company covering a variety of therapeutic areas and dosage forms and few OTC products. Our business focuses on the development of Abbreviated New Drug Application (ANDA) which is based on generic products through our global network of development and manufacturing partners and has a robust emerging pipeline of niche pharmaceutical products.”
The group’s manufacturing facilities are approved by several leading regulatory agencies like WHO-GMP, US FDA, UK MHRA, EUGMP, Health Canada, and many MOH across the globe. The group’s robust strengths include from R&D of API to API’s development to formulation research and development to formulation manufacturing to generic distribution as well as contract manufacturing and research make it at par with all other globally renowned pharmaceutical conglomerate. Espee Group strives to be a single point contact for all these requirements of developed large scale pharmaceutical manufacturers across the world.
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).