R&D and Manufacturing
研發(fā)與制造
R&D Overview
Poly Pharm adheres to the advanced manufacturing positioning of "differentiation + vertical integration of API and finished product + internationalization", strictly requiring drug quality comply with international GMP standards. It has established a complete quality system, standardized quality management and control systems, procedures and standards. The company has accumulated rich technical reserves and experience in drug formulation technology research and formulation global registration. In recent years, the company has continuously increased its R&D investment in the combination of"generic and innovative" research, targeting at those products with high technical difficulty and differentiation, and it has established an innovative drug research institute, a biotechnology research institute, a generic drug research institute, and a API research institute, with over 550 R&D personnel, accounting for one-third of the company's total employees.
R&D achievements
The company has obtained over 97 patents, including 80 invention patents, and has been granted 260 product approvals, including 82 for domestic chemical drugs, 121 for overseas preparation production permits in Europe and America, 44 for active pharmaceutical ingredient production permits and filings, and 8 for pharmaceutical excipient production permits and filings. Currently, there are over 150 ongoing research and development projects, involving first-to-file + patent challenge generic drugs, improved 505b(2) new drugs, and new entity compound drugs.
97
+ itemInvention patents
260
pcsProduct approval
82
+ itemDomestic chemical drug approvals
121
pcsProduction permits for preparations to overseas markets
44
pcsAPI production approvals
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