Polypeptide Suppliers FDA certification

Chengdu Shengnuo Bio-Pharmaceutical Co., Ltd. 0 has passed FDA certification.

Food and Drug Administration (FDA) is subordinate to the Department of health, education and welfare of the United States. It is responsible for the management of drugs, food, biological products, cosmetics, veterinary drugs, medical devices and diagnostic supplies.

Simple scale

FDA

Subordination

Department of health, education and welfare

take the charge of

National medicine, food, biological products, etc

Authorized institution

Congress is the federal government

Introduction to FDA learning

FDA is the abbreviation of U.S. Food and drug administration. It is an international medical audit authority authorized by the U.S. Congress, the federal government, and the highest law enforcement agency specialized in food and drug management.

FDA is a government health regulatory monitoring agency composed of doctors, lawyers, microbiologists, pharmacologists, chemists and statisticians, which is dedicated to protecting, promoting and improving national health. Food, drug, cosmetics and medical devices certified by FDA are safe and effective for human body. In the United States and other nearly 100 countries, only the FDA approved materials, devices and technologies can be used commercially.

Legal authorization

Most of the federal laws enforced by the FDA are incorporated into the federal food, drug, and Cosmetic Act, TITLE 21 of the United States Code. Other laws to be enforced by the agency include the public service act, the controlled substances act, the federal anti tampering act and the family smoking prevention and tobacco control act.

The FDA has a wide range of safety regulations. For example, the regulation of prescription drugs involves every aspect of it, from drug testing, manufacturing, labeling, advertising, marketing, effectiveness to drug safety. The management of cosmetics is limited to label specification and safety. The agency’s regulatory actions for most products are based on a series of open standards, supplemented by a certain number of instrument inspections.

Regulatory procedures

Food supervision

Drug supervision

Equipment supervision

Cosmetics supervision

Veterinary supplies supervision

Impact assessment

FDA has a great influence in the United States and even in the world, which is known as the American God of health.

Pharmaceutical and food manufacturers all over the world love and fear it, and its reputation and professional level are deeply trusted by many experts and people. Its strict testing and evaluation not only provide good guarantee, but also cause many drug and food manufacturers’ criticism, accusing it of constraining invention and innovation, which is the biggest obstacle to people’s access to specific drugs, and lobbying Congress to reduce the authority of FDA.

Concerns

Question 1: which agency issued the FDA certificate?

A: there is no certificate for FDA registration. If the product is registered in FDA, the registration number will be obtained. FDA will give the applicant a reply (signed by FDA Chief Executive), but there is no FDA certificate.

Question 2: does FDA need a designated certified Laboratory for testing?

A: the FDA is a law enforcement agency, not a service agency. If someone says that they are FDA’s Certification Laboratories, he is at least misleading consumers, because the FDA has neither public service certification bodies and laboratories, nor so-called “designated laboratories”. As a federal law enforcement agency, FDA is not allowed to engage in such matters as both referee and athlete. FDA will only recognize the GMP quality of service testing laboratories, and issue certificates of compliance, but will not “designate” or recommend a specific one or several to the public.

Question 3: does FDA registration require an American agent?

A: Yes, the Chinese applicant must appoint a U.S. citizen (company / Society) as its agent when registering with the FDA. The agent is responsible for the process service located in the U.S. and is the media to contact the FDA and the applicant.

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Shengnuo Biotechnology is a high-tech China polypeptide manufacturers,who has over 19 years experience for the biotechnology .Our Products involve peptide raw materials,polypeptide drug.

Our 0 defect has passed the FDA certification, and has become the first-class professional polypeptide drug and product development and large-scale production and export industry in China .

Our service scope：peptide synthesis、peptide hormones、peptide medicine、beauty peptide、peptide medicine product、peptide technology transfer、peptide technology service、peptide large-scale production、export of peptide

Thymopentin for Injection、 Thymalfasin for Injection 、 Bivalirudin 、Bulk Drug、 Liraglutide ……

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