Introduction
Founded in 2016, BL Pharma is an innovative pharmaceutical company for the research and development, manufacture, commercialization of high technology generic drug, MAH licensed services, the introduction of imported APIs, formulations, etc. into the Chinese market. By fully utilizing cutting-edge formulation technologies, and with in-depth cooperation with strategic customers, BL Pharma now has 100+ generic projects in the pipeline currently being developed to commercialization. In total 8 drugs have approved.
At the same time, BL Pharms also holds advanced CRO/CMO capabilities, to provide the biotech customers one-shop services and solutions on drug bio-equivalency (BE) studies, drug formulation studies, API process optimization, and drug quality upgrading activities. As we are experts on drug regulatory affairs, drug application and registration are also within out service scope.
So far, BL Pharma has kept strong business links with some big pharmaceutical companies, contributing to their projects which on both of the clinical phase and launched stage.
In addition, BL Pharma can provide the service to import the drugs, and perform the registration of API to the customers. A very professional and experienced drug filing team, from both of technical and regulatory perspectives, is the key to the high success rate. As a result, a global API supplier network and strategic partnership has been well established with the global pharmaceutical companies from Europe, the United States, Japan, India.
BL Pharma is located in Baoshan city industrial park, with a fully capable R&D center in about 1000 m2 dedicated building. This center is equipped with essential facilities, which are managed under cGMP. Projects are undertaken by multi-functional teams who are working at department of drug product, drug substances, quality control, quality assurance, drug registration & regulation, etc.
BL Pharma is a project-oriented company. We are committed to providing customers with the best service, creating the greatest value to the patients. To do so, all the activities are managed in a way to meet the project planning, to achieve timely delivery based on the agreed delivery date, to ensure the demanded quality of drug products, and most of all, to keep the data integrity and compliance.
Our strength is to create the opportunities based on the differentiation of drugs from the patient population.
Approved drugs: Propranolol tablet, Albuterol sulfate API, Aminocaproic acid injection, etc.
Ongoing projects (to be declared): Capecitabine tablets, Isotretinic acid, Dextromethorphan, Donepezil hydrochloride, Milinone, Ertapenem, etc.
Imported API records: Levothyroxine sodium, Glutamine, Famotidine, Tamoxifen citrate, Nicardipine hydrochloride
Qualification: Pharmaceutical production license; High-tech enterprise
Intellectual Property: 9 utility model patents + 4 invention patents
