Cirrus -Kemwell Receives FDA Grant to Evaluate Formulation Effects on MDI Performance
MORRISVILLE, North Carolina, October 10, 2013 /PRNewswire/ --
Cirrus Pharmaceuticals, Inc., NC, USA, a wholly owned subsidiary of Kemwell Biopharma Pvt. Ltd., announced that it was awarded a grant by the U.S. Food and Drug Administration 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 has a long tradition of providing services in the highly specialized field of respiratory product development. In addition to MDIs, Cirrus provides development services for dry powder inhalers (DPIs), nebulized solutions and suspensions, and nasal sprays.
Cirrus was acquired by Kemwell in July 2013 to give the best geographical advantage to the customer from cutting-edge development in the US to cost-effective manufacturing in India.
Cirrus Pharmaceuticals is based in Research Triangle Park, North Carolina and specializes in development of inhalation, parenteral, transdermal, topical, and liquid dosage forms. Cirrus supports the full range of regulatory filings and pathways globally, including IND, IMPD, NDA, 505(b)(2), 510(k), and aNDA. Cirrus applies advanced scientific knowledge and technological expertise to develop robust products that meet its clients' design criteria.
Read more about Cirrus at http://www.cirruspharm.com
Kemwell Biopharma Pvt Ltd with its head office in Bangalore, India is a pure-play contract development and manufacturing company. The company develops and manufactures bio/pharmaceuticals for some of the world's top pharmaceutical companies, including Bayer, Boehringer Ingelheim, GlaxoSmithKline, Merck KGaA, Novartis, and Pfizer. Kemwell is one of India's largest CDMOs for bio/ pharmaceuticals with over 30 years' experience. The company employs more than 1200 employees worldwide and has seven production facilities and state-of-the art research and development laboratories in India, Sweden and USA. Kemwell is an approved bio/pharmaceutical manufacturer in over 80 countries including the American, European, Japanese and Indian markets.
Read more about Kemwell at http://www.kemwellbiopharma.com
SOURCE Kemwell Biopharma Pvt Ltd