Overview of pharmaceutical intermediates industry

- Apr 19, 2018 -

Pharmaceutical intermediates is the intermediate material in the process of pharmaceutical technology, belonging to pharmaceutical fine chemicals production don't need a pharmaceutical production license, according to the degree of impact on the quality of the final API, can be divided into the GMP intermediates and GMP intermediates (ICHQ7 defined under the GMP production of pharmaceutical intermediates).

Pharmaceutical intermediates industry are those that according to the strict quality standard with chemical or biological synthesis methods for the pharmaceutical enterprises production and processing used in the manufacture of finished medicines of organic/inorganic chemical enterprise of intermediate or API.

1. The pharmaceutical intermediates sub-industry can be subdivided into CRO and CMO industries.

CMO: Contract ManufacturingOrganization refers to manufacturing enterprise of the agency Contract, means that pharmaceutical companies will be outsourced manufacturing partners. The business chain of the pharmaceutical CMO industry is usually started from specialized pharmaceutical raw materials. Industry companies need to purchase basic chemical raw materials and classify them into specialized pharmaceutical raw materials, and then gradually form the starting materials of API, cGMP intermediates, API and preparations. At present, the multinational pharmaceutical companies tend to establish long-term strategic partnership with a few core suppliers, and the survival of the industry company is basically clear through its partners.

CRO: Contract Research Organization. Pharmaceutical companies outsource Research to partners. At present the industry mainly to customize production, custom research and development as well as the medical contract research and sales as the main method of cooperation, either way, whether or not pharmaceutical intermediates products for innovative products, judge the enterprise's core competitiveness is still in research and development technology for the first element, lateral reflection for the company's downstream customers or partners.

2. From the classification of business model, intermediate enterprises can be divided into general mode and custom mode.

In general, the small and medium-sized intermediates production enterprises to adopt the general pattern, in the face of customers is more generic drugs production enterprise, and has strong research and development ability of large intermediates manufacturers use custom pattern, geared to the needs of customers as the innovation medicine enterprises, custom pattern can effectively enhance viscosity between with customers.

Under the general product model, enterprises can identify the general needs of the public customers according to the results of market research, and carry out specific business activities such as research and development, production and sales. That is to say, there is no established customer relationship between the enterprise and the mass customer before the specific operation. Since then, in the process of carrying out specific business activities, enterprises generally only maintain regular communication with the public customers, so as to ensure the common needs of the public customers. Therefore, general sales of the products is to have a universal product, no mass customers, business model is based on general products and core, between enterprise and the public customer customer relationship is a kind of loose. In the pharmaceutical industry, generic product models are mainly applicable to the r&d, production and marketing of pharmaceutical intermediates, apis and preparations needed for generic drugs.

In the custom mode, the customized customer will provide confidential information to the enterprise after signing the confidentiality agreement with the enterprise, and clearly customize the requirements. The enterprise starts from the custom demand of custom customer to carry on the specific business activity such as research and development, production, sale. That is to say, before the implementation of specific business activities, the enterprise has established a very determined customer relationship with the custom client. Since then, in the process of carry out specific activities, enterprises need to maintain constant system customer, two-way, depth of communication, in order to ensure the customization customers in all aspects of the customization requirements. Custom products sales, therefore, is to have a custom, custom products, and business model is based on a custom core, and enterprise and the custom is a close relationship between the customer. In the pharmaceutical industry, the customized mode is mainly applicable to the r&d, production and sales of pharmaceutical intermediates, apis and preparations needed for innovative medicine.

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