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01 1Fermion Oy
02 1TAPI Technology & API Services
03 1Alembic Pharmaceuticals Limited
04 2Aurobindo Pharma Limited
05 1BASF Corp
06 1Cadila Pharmaceuticals
07 1Changzhou Siyao Pharmaceuticals
08 1Cilag AG
09 1Erregierre SpA
10 1Industriale Chimica
11 1Natco Pharma
12 2Olon S.p.A
13 1Quimica Sintetica
14 1RANBAXY LABORATORIES LIMITED
15 1Recordati
16 1SIMS Srl
17 2Siegfried AG
18 1Sifavitor srl
19 2UQUIFA
20 2Wockhardt
21 1elm-plastic GmbH
01 1FLUOXETINE HCI
02 1FLUOXETINE HCL
03 1FLUOXETINE HCL EP/USP
04 2FLUOXETINE HCL USP
05 11FLUOXETINE HYDROCHLORIDE
06 5FLUOXETINE HYDROCHLORIDE USP
07 1FLUOXETINE HYDROCHLORIDE USP (PROCESS II)
08 1FLUOXETINE HYDROCHLORIDE USP-EP
09 1FLUOXETINE HYDROCHLORIDE, BULK
10 1FLUOXETINE HYDROCHLORIDE, USP
11 1FLUOXETINE HYDROCHORIDE
01 1China
02 1Finland
03 1Germany
04 8India
05 1Israel
06 7Italy
07 3Spain
08 3Switzerland
09 1Blank
01 12Active
02 14Inactive
01 7Complete
02 19Blank
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-13
Pay. Date : 2014-10-02
DMF Number : 11315
Submission : 1995-01-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-22
Pay. Date : 2017-02-06
DMF Number : 12146
Submission : 1996-10-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18980
Submission : 2005-11-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-31
Pay. Date : 2013-07-19
DMF Number : 14253
Submission : 1999-06-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10837
Submission : 1994-03-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-06
Pay. Date : 2016-07-27
DMF Number : 21895
Submission : 2008-08-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8695
Submission : 1990-08-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-05-27
Pay. Date : 2021-03-03
DMF Number : 12291
Submission : 1996-12-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21768
Submission : 2008-07-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12009
Submission : 1996-06-19
Status : Active
Type : II
A Fluoxetine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fluoxetine Hydrochloride, including repackagers and relabelers. The FDA regulates Fluoxetine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fluoxetine Hydrochloride 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 Fluoxetine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fluoxetine Hydrochloride supplier is an individual or a company that provides Fluoxetine Hydrochloride active pharmaceutical ingredient (API) or Fluoxetine Hydrochloride finished formulations upon request. The Fluoxetine Hydrochloride suppliers may include Fluoxetine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Fluoxetine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fluoxetine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Fluoxetine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Fluoxetine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Fluoxetine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fluoxetine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Fluoxetine Hydrochloride USDMF includes data on Fluoxetine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fluoxetine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fluoxetine Hydrochloride suppliers with USDMF on PharmaCompass.
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