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FDA Approved API Manufacturers List 2022


FDA is one of the executive agencies established by the U.S. government in the Department of Public Health (PHS) under the Department of Health and Human Services (DHHS). FDA mainly includes testing and registration. Medical devices, cosmetics, food and drug products need FDA registration, and FDA registration can be directly applied on the FDA official website.

FDA was established in 1906. There was no regulation on drugs in the United States, and drugs were sold through advertising before 1906. In 1938, FDA required that drugs be sold only after their safety was proved. In 1962, FDA required that drugs not only be safe but also effective before they could be sold.


Table: FDA Approved API Manufacturers List

ManufacturersHeadquarters
Pfizer Inc.

New York, NY

BioNTech SEGermany
NecLifeChandigarh, India
WuXi AppTecWuxi, China
Aadivighnesh Chem Pvt LtdMumbai, India
Alkem Labs LtdMumbai, India


Pfizer develops and produces medicines and vaccines for immunology, oncology, cardiology, endocrinology, and neurology. The company has several blockbuster drugs or products that each generate more than US$1 billion in annual revenues. In 2020, 52% of the company's revenues came from the United States, 6% came from each of China and Japan, and 36% came from other countries.

   
   

BioNTech SE (short for Biopharmaceutical New Technologies) is a German biotechnology company based in Mainz that develops and manufactures active immunotherapies for patient-specific approaches to the treatment of diseases. It develops pharmaceutical candidates based on messenger ribonucleic acid (mRNA) for use as individualized cancer immunotherapies, as vaccines against infectious diseases and as protein replacement therapies for rare diseases, and also engineered cell therapy, novel antibodies and small molecule immunomodulators as treatment options for cancer.

   


Nectar Lifesciences Limited is a pharmaceutical company in India that manufactures generic drug products. The company has global leadership in several oral and sterile cephalosporin drugs, and has cGMP facilities along with those approved by the European Union and Japan.

   


WuXi AppTec (WuXi pronounced Wu-shee) is a global pharmaceutical, biopharmaceutical, and medical device company. The company covers the development cycle through five core operations, including small molecule R&D and manufacturing, biologics R&D and manufacturing, cell therapy and gene therapy R&D and manufacturing, medical device testing, and molecular testing and genomics.

   


Aadivighnesh Chem Pvt Ltd is a leading company, involved in global supply and manufacture of Active Pharmaceutical Ingredients offering high quality products to the pharmaceutical and biotechnology industries. The success is based on providing a value added service by adopting a customer orientated approach. The corporate independence allows it to respond as fast as possible, gives it a greater flexibility, and enables it to invest in plant and processes.


Alkem Laboratories Limited is an Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra, India that manufactures and sells pharmaceutical generics, formulations and nutraceuticals in India and globally.

 


Wuhan Fortuna Chemical Co.,Ltd, established in 2006, is a big integrative chemical enterprise being engaged in Pharmaceutical & its intermediates, Food/Feed additives, Fine chemicals in distributing the products of our own company and affiliated enterprises. It has professional persons who major in chemical R&D and sicentific management, supply fine chemical products with high quality and close service, also supply custom-tailored products according to our clients' requirement. Since founded, Wuhan Fortuna Chemical Co., Ltd continuously innovates the products and improve the service and sales network. Hence, the company initiates the first sale mode on net in China, which is the retail trade of small package bring along wholesale of diversified management modes. Its products are exported widely to South Korea, Vietnam, Australia, Europe and South America, highly recommended by our clients.


   


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