Beijing Second Pharmaceutical Co., Ltd. has gained U.S. Food and Drug Administration (FDA) approval of ANDA 090752 for amlodipine besylate. BSPC is a China-based generic pharmaceutical company focused on manufacturing ophthalmic dosage forms and oral solid dosages targeted for cardiovascular therapies, utilizing their EU and US cGMP-compliant finished product and API facilities. The approval represents a milestone for the Chinese pharmaceutical industry, as BSPC will become the first Chinese-owned pharma firm to be able to launch an FDA-approved Oral Solid Dose product on the US market. The product will be marketed by a US-based distribution partner with harmonized vision for supplying generics in the US marketplace.
As part of the collaborative efforts between Frontage Laboratories and BSPC, Frontage developed the generic-equivalent formulation and analytical methodologies, provided GMP training and facilities commissioning services, performed technical transfer and scale-up of the developed formulation process, assisted in the execution of the submission batch manufacturing, executed the bioequivalence study, and compiled the electronic ANDA application on behalf of BSPC.
Frontage received approval from the Division of Bioequivalence for its client on April 15th, confirming that the amlodipine besylate tablets USP developed by Frontage for BSPC are bioequivalent and therapeutically equivalent to the reference listed drug Norvasc, manufactured and marketed by Pfizer, Inc.
Date: May 3, 2011
Source: Beijing Second Pharmaceutical Co., Ltd.
Filed Under: Drug Discovery
