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List of Drug Master Files (DMF) of Ludiflash Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 4SPI Pharma

02 1Pfanstiehl

03 1Anmol Chemicals

04 1BASF

05 1Freund Vector Corporation

06 1Kerry

07 3Roquette

08 1S D Fine Chem Limited

09 1Shandong Tianli Pharmaceutical Co ltd

10 1Viatris

11 1Westpoint pharma

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 16037

Submission : 2002-07-03

Status : Active

Type : IV

SPI Pharma

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 32464

Submission : 2018-02-15

Status : Active

Type : IV

Pfanstiehl

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 28402

Submission : 2014-06-18

Status : Active

Type : IV

SPI Pharma

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 24099

Submission : 2010-08-27

Status : Active

Type : IV

SPI Pharma

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 17044

Submission : 2003-12-22

Status : Active

Type : IV

SPI Pharma

06

Discovery on Target
Not Confirmed

07

Discovery on Target
Not Confirmed

07

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