Pharmaceutical plants need to apply for a drug production license, business license, organization code, national tax, local tax, refined process GMP certificate.
1, the start of the pharmaceutical production enterprise applicants should be located in the provincial drug supervision and management department to apply for the establishment.
Provincial drug supervision and management departments since the receipt of the application within 30 working days to make a decision on whether to agree to set up - the applicant to complete the establishment of the enterprise should be applied to the original approval department for acceptance - the original approval department should be applied for 30 working days since the receipt of the application based on the "Drug Administration Law", Article 8: the start of drug production enterprises must have the conditions to organize acceptance. The original approval department shall, within working days from the receipt of the application, organize the acceptance inspection according to Article 8 of the Drug Administration Law: conditions that must be met to start a drug manufacturing enterprise. The qualified ones shall be issued the Drug Manufacturing License.
2, the applicant with the "Drug Manufacturing License" to the administration for industry and commerce to register according to law, to receive the "business license".
3, drug manufacturers to produce drugs must be registered by the State Drug Administration, issued by the drug production documents (i.e., drug approval number) before the production of drugs. The process of applying for registration of a drug is very complicated and cannot be explained in detail here.
Expanded:
Technological developments:
The biopharmaceutical camp is large and growing fast. Half of the world's pharmaceuticals are already biosynthesized, especially when synthesizing drugs with complex molecular structures; it is not only easier than the chemical synthesis method, but also has higher economic benefits.
Half a century since the development of a variety of biopharmaceutical analytical systems and microbial transformation in the development of a series of breakthroughs in the application of the pharmaceutical industry to create a huge medical value and economic benefits. Microbial pharmaceutical industrial production is characterized by the use of a certain microorganisms to the "pure state", that is, not only the "seed" to be superior and can only be a kind of, such as other strains come in that is a hybrid bacteria.
Fixed product, there must be according to the process of its most suitable "rice" - medium, for its growth. The composition of the medium can not be changed at will, a strain in the same fermentation medium.
Because only less or more of a component, the fermentation of the finished product is completely different. Such as Streptomyces aureus in the chloride-containing medium can form aureomycin, and in the absence of chloride or in the medium to add inhibit the generation of chlorinated substances, produce tetracycline. Drug-producing bacteria into the fermenter production.
Baidu Encyclopedia - Biopharmaceuticals