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Generated: November 19, 2018

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Drug Master Files for: Jiangsu Hengrui Med

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Jiangsu Hengrui Med Drug Master Files

DMF No. Status Type Submission Date Holder Subject
11290 A II 1/11/1995 JIANGSU HENGRUI MEDICINE CO LTD IFOSFAMIDE USP, NON-STERILE, BULK DRUG SUBSTANCE
14316 I II 7/29/1999 JIANGSU HENGRUI MEDICINE CO LTD THIOTEPA USP NON STERILE BULK DRUG
20665 A II 7/9/2007 JIANGSU HENGRUI MEDICINE CO LTD OXALIPLATIN USP
20739 A II 8/1/2007 JIANGSU HENGRUI MEDICINE CO LTD IRINOTECAN HYDROCHLORIDE USP (NON-STERILE BULK) DRUG SUBSTANCE
22015 A II 9/19/2008 JIANGSU HENGRUI MEDICINE CO LTD GABAPENTIN, USP, NON-STERILE, BULK DRUG SUBSTANCE
23695 I II 4/7/2010 JIANGSU HENGRUI MEDICINE CO LTD TAMSULOSIN HYDROCHLORIDE USP, NON-STERILE, BULK SUBSTANCE
23831 A II 5/24/2010 JIANGSU HENGRUI MEDICINE CO LTD LETROZOLE USP NON-STERILE BULK DRUG SUBSTANCE
DMF No. Status Type Submission Date Holder Subject

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Drug Master File Glossary

STATUS OF DMFS

  • A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
  • I = Inactive
  • N = Not an assigned number
  • P = DMF Pending Filing Review

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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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

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