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

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$ API Ref.Price (USD/KG) : 5,085Xls
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01 1Veranova

02 1Alkem Laboratories

03 1American Pacific Corporation

04 1Chattem Chemicals, Inc

05 1Curia

06 1Lonza Inc & Lonza America Inc

07 1Mallinckrodt Pharmaceuticals

08 1Siegfried AG

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothVeranova: A CDMO that manages complexity with confidence.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 15059

Submission : 2000-09-22

Status : Active

Type : II

Veranova

03

Pharmaconex 2024
Not Confirmed

03

Pharmaconex 2024
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2017-11-07

Pay. Date : 2017-10-10

DMF Number : 29784

Submission : 2015-10-07

Status : Active

Type : II

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04

Pharmaconex 2024
Not Confirmed

04

Pharmaconex 2024
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2013-07-31

Pay. Date : 2013-07-23

DMF Number : 22998

Submission : 2009-09-23

Status : Active

Type : II

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07

Pharmaconex 2024
Not Confirmed

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