Frontage & BSPC Receive FDA Approval for Generic Norvasc

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.

Beijing Second Pharmaceutical Co., Ltd. (BSPC), a China-based generic pharmaceutical company, has received FDA approval of its ANDA 090752 for Amlodipine Besylate, a generic form of Pfizer’s Norvasc.

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.

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 electron