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

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$ API Ref.Price (USD/KG) : 101Xls
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01 1Polpharma

02 1Taro Pharmaceutical Industries

03 1Amsa Spa

04 1ChemSource

05 1Chemi SpA

06 1Emcure Pharmaceuticals

07 1Fleming Laboratories

08 3Ipca Laboratories

09 1Kreative Organics

10 1Lonza Group

11 1Lonza Inc & Lonza America Inc

12 1Pfizer Inc

13 1Quimica Sintetica

14 1RANBAXY LABORATORIES LIMITED

15 1Teva API

16 1ULKAR KIMYA SANAYII VE TICARET

17 1Yangzhou Pharmaceutical

18 1Zhejiang chiral Medicine Chemicals Co

19 1Zydus Lifesciences

20 2Blank

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

GDUFA

DMF Review : Complete

Rev. Date : 2014-12-16

Pay. Date : 2014-11-28

DMF Number : 11405

Submission : 1995-03-29

Status : Active

Type : II

Polpharma CB

03

Formnext Forum
Not Confirmed

03

08

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Not Confirmed

09

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Not Confirmed

09

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Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2015-03-09

Pay. Date : 2015-03-04

DMF Number : 16789

Submission : 2003-08-25

Status : Active

Type : II

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