Beijing Second Pharmaceutical Co., Ltd. (BSPC) has received FDA approval of its ANDA 090752 for Amlodipine Besylate, a generic form of Pfizer’s Norvasc. BSPC is a China-based generic pharmaceutical company focused on manufacturing ophthalmic dosage forms and oral solid dosages targeted for cardiovascular therapies at its EU and U.S. cGMP-compliant finished product and API facilities.

With this approval, BSPC will become the first Chinese-owned pharma firm to be able to launch an FDA-approved oral solid dose product on the U.S. market. A U.S.-based distribution partner will market the product.

Working with BSPC, Frontage Laboratories, Inc. 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 BSPC on April 15th, confirming that the Amlodipine Besylate Tablets USP developed by Frontage for BSPC is bioequivalent and therapeutically equivalent to the reference drug Norvasc.