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Active Pharmaceutical Ingredients

Shanghai Biopharmaleader Co.,Ltd | Updated: Feb 23, 2017

The Pharmaceutical Ingredients segment has two product groups: Pharmaceutical Intermediate and Active Pharmaceutical Ingredients (APIs).

Biopharmaleader supplies APIs to many of the major generic drug companies, who we believe view Biopharmaleader as a valued partner in their effort to develop and market generic drugs. The process of introducing a new API from pipeline to market spans a number of years and begins with Biopharmaleader partnering with a generic pharmaceutical manufacturer and jointly selecting an API, several years before the expiration of a compostion of matter patent, for future genericizing. We then identify the appropriate supplier, and concurrently utilizing our global technical network, work to ensure they meet standards of quality to comply with regulations. Our client, the generic pharmaceutical company, will submit the Abbreviated New Drug Application (ANDA for U.S. Food and Drug Administration (FDA) approval or European-equivalent approval. The introduction of the API to market occurs after all the development testing has been completed and the ANDA or European-equivalent is approved and the patent expires or is deemed invalid. Biopharmaleader has a pipeline of APIs at various stages of development both in the United States and Europe. Additionally, as the pressure to lower the overall cost of healthcare increases, Biopharmaleader has focused on, and works very closely with our customers to develop API opportunities to provide alternative, more economical, second-source options for existing generic drugs. By leveraging our worldwide sourcing, regulatory and quality assurance capabilities, we provide to generic drug manufacturers an alternative, economical source for existing API products. 

Additionally, as the pressure to lower the overall cost of healthcare increases, Biopharmaleader has focused on, and works very closely with our customers to develop new API opportunities to provide alternative, more economical, second-source options for existing generic drugs. By leveraging our worldwide sourcing, regulatory and quality assurance capabilities, we provide to generic drug manufacturers an alternative, economical source for existing API products.


Shanghai Biopharmaleader Co.,Ltd is a young and innovative company specializing in the design and synthesis of organic compounds for pharmaceutical, medicinal chemistry, biotechnology, drug discovery industries and world's top universities.

We specialize in complex, multi-stage custom synthesis and process research. We are capable of supplying mg to multiple-ton quantities of key pharmaceutical intermediates and Bioactive Molecules, pre-clinical and high-throughput screening compounds, analogues, building blocks.

More information on Pharmaceutical Intermediate   http://www.biopharmaleader.net/pharmaceutical-intermediate/


Shanghai Biopharmaleader Co.,Ltd