PHARMACEUTICALS EXPORT PROMOTION COUNCIL (Set up by Ministry of Commerce & Industry, Govt. of India)

Ref: PXL/H.O./CIR-057/2010-11                                              Date: 28.10.2010

To
All the Members of Council,

Dear Member,

As members are aware the Drug Master File (DMF) is a submission of technical documentation of an Active Pharmaceutical Ingredient (API) to the USFDA and plays a crucial role when a formulation apply for regulatory approvals and Market Authorizations. Acting as a master document, the DMF is important in maintaining current supplier agreements as well as in developing new business relationships.

USFDA maintains following 5-types of DMFs,

Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)

Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product

Type III: Packaging Material

Type IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation

Type V: FDA Accepted Reference Information

Considering the importance of DMFs for our pharmaceutical member companies (both API & formulation manufacturer), Pharmexcil has carried out an extensive search and compiled a database on Type-II active DMFs (Active means acceptable for filing, administratively, and is up-to-date).

As on 11th June, 2010, of the total 7,121 type–II active DMFs filed by 1082 companies globally (belonging to 58 countries) with U.S. FDA, India has filled 2,234 type–II active DMFs by 340 (31.37% of total) and is currently the largest filer with U.S. FDA.

Database summary highlights

• ·         Total number of type II active DMFs-7121
• ·         Total number of Countries-58
• ·         Total number of Companies- 1082
• ·         Total number of Indian companies- 340

For in-depth details regarding the DMF number, company, site of manufacture, molecule etc (relating India & Global), member may contact Pharmexcil at research@pharmexcil.com.

Yours Truly,

Dr.P.V. Appaji

Executive Director