APIs
Qilu Pharmaceutical is a global leader in the development and manufacturing of active pharmaceutical ingredients (APIs).
We manufacture more than 100 APIs for human health, animal health and agricultural products, and we are the world’s leading manufacturer of Cefprozil, Cefepime ( L – arginine) and Ceftazidime (sodium carbonate), which are a wide range of third and fourth generation antibiotics belonging to the celaphosporin group, used to treat infections produced by gram-positive and gram-negative bacteria, and they are mainly used in hospitals.
Qilu Pharmaceutical have the approval of the main regulatory agencies for Good Manufacturing Practices, such as:
- USFDA (US Food and Drug Administration)
- EDQM (European Directorate for the Quality of Medicines)
- TGA (Therapeutic Goods Admnistration of Australia)
- MHRA (Medicine and Healthcare products Regulatory Administration United Kindom)
- MCC (Medicine Control Council Africa)
- MHLW (Ministry of Health, Labour and Welfare Japan)
- KFDA (Korea Food and Drug Administration)
The Company has successfully completed its audits, endorsing our quality standards.
General information about APIs
Active pharmaceutical ingredients or APIs can be defined as the chemicals used to manufacture pharmaceutical drugs. The active ingredient (AI) is the substance or substances which are biologically active within the drug and is the specific component responsible for the desired effect on the individual taking it.
Any drug or medication is made up of two components. The first is the API – which is the main ingredient. The second is known as the excipient, which is the inactive substance that serves as the vehicle for the API itself.
APIs are generally manufactured through a variety of processes that include:
- Chemical synthesis
- Fermentation processes
- Recombinant DNA
- Isolation and recovery from natural sources
- A combination of these processes
The Active Pharmaceutical Ingredient Industry manufactures these ingredients from raw materials by both chemical and physical means and, depending on the molecule´s complexity, the synthesis of APIs may need multiple complex chemical stages utilizing a wide range of technologies.
Regardless of where the active pharmaceutical ingredient is made, companies must adhere to strict safety and quality standards set by the country where it will be used.
API drug manufacturing, storage and packaging are subject to Current Good Manufacturing Process (CGMP) regulations enforced by the International Regulatory Agencies.
Qilu Pharmaceutical manufactures over 70 APIs and is the largest manufacturer of Cefprozil, Cefepime ( L – arginine) and Ceftazidime (sodium carbonate).
