Study On The Export, International License And Contract Manufacture In Chinese Pharmaceutical Manufacturers

A new opportunity to Chinese pharmaceutical industry is emerging along with the multinational pharmaceutical companies moving production to low cost area and increasing the global generic market. Although it appears to be a long pursuit for China to export finished drug products to abroad directly, especially to European, American markets, the so called regulated market, under the"Eleventh Five-Year Plan"which promotes the development of"international market for finished dosage forms"and the reform of export product structure, most of domestic companies feel rather"crippled"in front of the overseas regulatory control, brand management and market maintenance. In the mean time, Original Equipment Manufacture or OEM, as a mature business mode, has been widely used in other countries and regions. Such an approach requires that China pharmaceutical industry be engaged in international GMP certification and contract manufacturing business. This, as an interim business strategy, has been successfully pioneered by some companies to date. This paper provides a thorough analysis of the contract manufacturing business for finished dosage form, specifically the rationale, work flow and time table for Chinese pharmaceutical manufacturers to obtain international GMP certification and to carry out contract manufacturing business. This paper further discusses the misconceptions in the industry in terms of price, qualification, and enterprise weaknesses. With a vision in the contract manufacturing business, this paper raises the point that Chinese manufacturers have to move from old-fashioned business models to international competitiveness.This paper draws the conclusion that Chinese pharmaceutical producers shall take an appropriate strategy, and establish a clear position on the basis of their own capabilities on the targeting markets. International contract manufacturing business might not be the only way to utilize the excess production capability in local manufacturers, nor it would ensure a quick investment return. Those high-technology companies may try to access developed countries, and use OEM mode effectively to gain experience, and to accumulate capitals, and eventually to launch products with their own brands. While, less competitive companies may consider the developing countries for a lower barrier of entry. Only those in the Chinese pharmaceutical industry who establish long term business development strategy and stable customer partnership will be able to grasp and benefit from the opportunities created in this manufacturing and market restructuring worldwide.