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Peptides

A peptide is a short string of 2 to 50 amino acids, formed by a condensation reaction, joining together through a covalent bond. Sequential covalent bonds with additional amino acids yield a peptide chain and the building block of proteins.

RA Consultation

Give guidance to domestic API and intermediate enterprises to establish GMP in compliance with US FDA, and provide the preparation, review and advice of DMF.

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Anti-biotics

Antibiotics are medicines that fight bacterial infections in people and animals. They work by killing the bacteria or by making it hard for the bacteria to grow and multiply

Antineoplastic

Antineoplastic drugs are medications used to treat cancer. Other names for antineoplastic drugs are anticancer, chemotherapy, chemo, cytotoxic, or hazardous drugs.These drugs come in many forms, including liquids or pills.

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Frequently Asked Questions

API (Active Pharmaceutical Ingredient) means the active ingredient which is contained in medicine. For example, an active ingredient to relieve pain is included in a painkiller. This is called API. A small amount of the active ingredient has an effect, so only a tiny part of the active ingredient is contained in medicine. You will find the name and amount of the active ingredient contained in the medicine on the package of OTC (over-the-counter) drugs.

We manufacture APIs and drug manufacturers make medicines from APIs. In addition to APIs, a variety of pharmaceutical excipients are contained in the medicine. Drug manufacturers make medicines by mixing APIs and pharmaceutical excipients. This is how an API becomes a medicine. It is delivered to hospitals and pharmacies until it reaches the patient. If an API is not ultrapure, a medicine cannot meet the strict quality criteria so the quality of an API plays a very important role.

In December 1, 2019 the Chinese GMP and GSP came to the end.

The newly revised Drug Administration Law has come into effect on December 1, 2019. This amendment is the most major amendment of this law in 18 years. One of the major amendment is the cancellation of GMP and GSP certification. In other words, Chinese GMP certification which was very important to many pharmaceutical enterprises in China has been officially canceled.

Why Chinese GMP Certification is Canceled?

All Chinese drug manufacturers required Good Manufacturing Practice (GMP) certification. GMP certification was previously thought to approve the operation after obtaining the certificate, however, many pharmaceutical enterprises begin to relax after obtaining GMP certification by all manner of means, so that the regulator has to use great efforts every year to investigate and revoke GMP certificates of enterprises breaking law.

Will the Chinese GMP Certification Cancellation Result in Deregulation of Quality Management in Chinese many pharmaceutical enterprises?

The answer is absolutely no. The cancellation of GMP and GSP certifications will not result in the deregulation of the quality management of the manufacture and trade of drugs; rather, the New Law establishes a higher requirement for enterprises. Instead, the New Law requires that drug manufacturing enterprises and drug trading enterprises establish and improve the quality management systems of manufacture and trade of drugs, and ensure that the process of manufacturing and trading of drugs always meets all legal requirements. In other words, a stricter form of supervision is implemented.

To sum up, although Chinese GMP certification and Chinese GSP certificate is canceled, the supervision of pharmaceutical enterprises is stricter than ever in China and the entry level of Chinese pharmaceutical enterprises are higher.