Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1Polpharma
02 1TAPI Technology & API Services
03 1Amsa Spa
04 1ChemSource
05 1Chemi SpA
06 1Emcure Pharmaceuticals
07 1Fleming Laboratories
08 3Ipca Laboratories
09 1Kreative Organics
10 1Lonza Group
11 1Pfizer Inc
12 1Quimica Sintetica
13 1RANBAXY LABORATORIES LIMITED
14 1Taro Pharmaceutical Industries
15 1ULKAR KIMYA SANAYII VE TICARET
16 1Yangzhou Pharmaceutical
17 1Zhejiang chiral Medicine Chemicals Co
18 1Zydus Lifesciences
19 2Blank
01 17-ETHYLTRYPTOPHOL (INTERMEDIATE FOR ETODOLAC
02 9ETODOLAC
03 1ETODOLAC (ETODOLIC ACID)
04 2ETODOLAC DRUG SUBSTANCE
05 1ETODOLAC MICRONIZED AS PROCESSED IN THE KALAMAZOO, MICHIGAN FACILITY
06 5ETODOLAC USP
07 1ETODOLAC USP (ED6 PROCESS)
08 1ETODOLAC USP (ED7 PROCESS)
09 1ETODOLAC USP MICRONIZED
01 2China
02 8India
03 1Israel
04 2Italy
05 1Poland
06 1Spain
07 1Switzerland
08 1Turkey
09 3U.S.A
10 2Blank
01 11Active
02 11Inactive
01 7Complete
02 15Blank
Polpharma 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
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-29
Pay. Date : 2012-11-08
DMF Number : 11766
Submission : 1995-12-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11359
Submission : 1995-02-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-14
Pay. Date : 2013-03-06
DMF Number : 25808
Submission : 2012-03-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-07
Pay. Date : 2013-03-18
DMF Number : 24868
Submission : 2011-05-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-08-15
Pay. Date : 2017-02-02
DMF Number : 24422
Submission : 2010-12-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15339
Submission : 2001-04-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24936
Submission : 2011-05-12
Status : Active
Type : II
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
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23688
Submission : 2010-04-05
Status : Active
Type : II
A Etodolac manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Etodolac, including repackagers and relabelers. The FDA regulates Etodolac manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Etodolac API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Etodolac manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Etodolac supplier is an individual or a company that provides Etodolac active pharmaceutical ingredient (API) or Etodolac finished formulations upon request. The Etodolac suppliers may include Etodolac API manufacturers, exporters, distributors and traders.
click here to find a list of Etodolac suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Etodolac DMF (Drug Master File) is a document detailing the whole manufacturing process of Etodolac active pharmaceutical ingredient (API) in detail. Different forms of Etodolac DMFs exist exist since differing nations have different regulations, such as Etodolac USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Etodolac DMF submitted to regulatory agencies in the US is known as a USDMF. Etodolac USDMF includes data on Etodolac's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Etodolac USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Etodolac suppliers with USDMF on PharmaCompass.
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