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Trials & Filings

Cirrus Receives MDI Grant

Kemwell unit to collaborate with FDA on formulation effects

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Cirrus Pharmaceuticals, a wholly owned subsidiary of Kemwell Biopharma Pvt. Ltd., has been awarded a grant by the FDA entitled, Comprehensive Evaluation of Formulation Effects on Metered Dose Inhaler Performance. The goals of the program are to investigate the effects of excipient concentrations and API particle size on the aerosolization performance of metered dose inhaler (MDI) formulations and to evaluate the sensitivity of in vitro methods in detecting those changes.

“We are very excited to collaborate with the FDA to add to the scientific knowledge base in this area and to enhance the Agency’s reviewing process under the Quality by Design (QbD) paradigm,” said Dr. Jay Holt, Sr., director for Inhalation & Analytical Testing, Cirrus Pharmaceuticals.

Cirrus was acquired by Kemwell in July 2013.

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