ANVISA certifies Next Breath as center for in-vitro pharmaceutical equivalence

Friday, May 02, 2014, 14:15 Hrs  [IST]

Next Breath, LLC, a member of Aptar Group,  has successfully completed its audit carried out by the Brazilian National Sanitary Surveillance Agency (ANVISA) and its facility is now recognised as a Center for Pharmaceutical Equivalence (EQFAR).

As a result, Next Breath is now authorized to conduct Pharmaceutical Equivalence studies for Brazil. In November 2013, ANVISA performed a week-long comprehensive audit of Next Breath’s quality systems.

The audit focused on ensuring that all quality systems, analytical capabilities, regulatory expertise and statistical expertise meet ANVISA’s rigorous standard for becoming an approved Center for Pharmaceutical Equivalence. The successful audit approves Next Breath for performing in vitro pharmaceutical equivalence and submission of Nasal Sprays, Dry Powder Inhalers (DPIs), and Pressurized Metered Dose Inhalers (pMDIs) to the Brazilian authorities.

Only ANVISA certified laboratories are authorized to perform in-vitro pharmaceutical equivalence testing for generic applications in the Brazilian market. The Center for Pharmaceutical Equivalence certification makes Next Breath the only laboratory outside Brazil certified to perform in vitro pharmaceutical equivalence testing for use in the Brazilian market.

According to Dr. Julie Suman, president, Next Breath, the recognition as an EQFAR laboratory allows us to bring our scientific expertise and know-how to advance generic drug approvals.

“ANVISA’s certification is an important milestone for Next Breath. The ability to support our partners will be greatly enhanced with Next Breath’s direct engagement of ANVISA”, stated Badre Hammond, Associate Director,  Business Development, Next Breath.

Aptar Group is a cGMP specialty Contract Research Organization (CRO) with analytical expertise for pharmaceutical, biotechnology, and consumer health product development focused on pulmonary, nasal, topical and ophthalmic delivery systems. Next Breath provides comprehensive solutions to the development processes from proof of concept to commercialization. It  has led successful submissions for pulmonary and nasal drug products and devices in the US and international markets.