As a manufacturer and supplier of APIs, our products meet multiple international standards to ensure the quality, effectiveness and safety of our products.
For specific product catalog and information, please visit here.
Such as Dexamethasone Powder(Specification: USP/BP/EP), Adapalene Powder(Specification:USP, EP, and BP standards),
Progesterone Powder(Specification: EP10,USP43,CP2015,IP2010), Estrone Powder (Specification: USP39), Minoxidil Powder(Specification: USP42,) , Ursodeoxycholic Acid UDCA(Specification: EP8), Semaglutide, Tirzepatide and so on.
1. Good Manufacturing Practice (GMP):
GMP stands for Good Manufacturing Practice. It is a set of quality standards that ensure that the production and control of drugs always meet their intended use. It is generally set by regulatory agencies, such as the FDA in the United States and the EMA in Europe.
2. Pharmacopoeia standards:
Such as the United States Pharmacopoeia (USP), the European Pharmacopoeia (Ph. Eur), the Chinese Pharmacopoeia, the Japanese Pharmacopoeia (JP), and the Indian Pharmacopoeia, provide quality and purity standards for APIs. These standards are widely recognized and used in pharmaceutical production.
3. FDA guidance documents:
The FDA has issued various guidance documents related to API production, which provide recommendations for compliance with US regulatory requirements.
4. ISO standards:
The International Organization for Standardization (ISO) has developed standards related to quality management systems (such as ISO 9001) and environmental management systems (such as ISO 14001) related to API production.
5. ICH Q7 Guide:
This guide provides GMP guidelines for API production, including principles and procedures for ensuring API quality.
The 90th China International Pharmaceutical API/Intermediates/Packaging/Equipment Fair will be held at the Shanghai National Exhibition and Convention Center from May 15 to 17, 2024.
API China-brings together advanced products and technologies in the industry, focusing on improving the overall level of production and research and development of Chinese pharmaceutical APIs, intermediates, and pharmaceutical excipients, improving the industry's production level and reflecting the industry's development trends. The exhibition provides pharmaceutical companies' decision-makers, purchasers, technicians, and R&D personnel with opportunities to establish information exchanges and business cooperation with target customers.
Purpose of the exhibition:
Keep up with the latest industry trends and policies.
Meet with a huge number of visitors from the global pharmaceutical and biopharmaceutical markets.
The exhibition contents include: Pharmaceutical Ingredients, Active Pharmaceutical Ingredients (APIs),Biopharma, CRO/CMO/CDMO, Fine Chemicals Intermediates, Natural Extracts, Nutritional (Functional) Food Ingredients, Veterinary Active Ingredients, Flavors, Sweeteners, Colorants.
All auxiliary materials, functional ingredients, internal and external packaging materials, production and testing equipment required for the production of medicines and health products.
