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List of all Manufacturers, Suppliers & Exporters of NCGC00024579-04 API listed on PharmaCompass with details of regulatory filings

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01 Polpharma (1)

02 Jai Radhe Sales (1)

03 Aspen API (3)

04 Fareva (2)

05 Seqens (1)

06 LGM Pharma (1)

07 HRV Global Life Sciences (1)

08 Sigmak Lifesciences (1)

09 Aspire Lifesciences Pvt Ltd (1)

10 Bal Pharma (1)

11 Bioindustria L.I.M. Spa (1)

12 Cerata Pharmaceuticals (1)

13 Cohance Lifesciences (1)

14 Darou Pakhsh Pharma Chem (1)

15 Erregierre SpA (1)

16 Globofarm International (1)

17 Guangzhou Tosun Pharmaceutical (1)

18 IBI Spa (1)

19 Mankind Pharma (1)

20 Medilux Laboratories Pvt Ltd. (2)

21 Medtronic Plc (1)

22 Novartis Pharmaceuticals Corporation (1)

23 Piramal Pharma Solutions (1)

24 RA CHEM PHARMA LIMITED (1)

25 Ramdev Chemicals Pvt Ltd (1)

26 Reine Lifescience (1)

27 Resolution Chemicals Limited (3)

28 Resonance Laboratories Pvt. Ltd (1)

29 SNA Healthcare (1)

30 Sumitomo Chemical (1)

31 Symed Labs (1)

32 Synthetic Molecules Private Limited (1)

33 Unichem Laboratories Limited (1)

34 Viatris (1)

35 Viyash Life Sciences (1)

36 Blank (1)

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01 China (1)

02 France (1)

03 India (20)

04 Iran (1)

05 Italy (3)

06 Japan (1)

07 Luxembourg (2)

08 Netherlands (3)

09 Poland (1)

10 Switzerland (1)

11 U.S.A (4)

12 United Kingdom (3)

13 Blank (1)

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01 Active (17)

02 Inactive (7)

03 Blank (18)

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01 Valid (7)

02 Blank (35)

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01 220MF10253 (1)

02 230MF10014 (1)

03 Blank (40)

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01 WC-0015 (1)

02 WC-0123 (1)

03 WC-0150A3-4 (1)

04 WC-0381 (1)

05 WC-0381n (1)

06 Blank (37)

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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

Close WC

Application Number
18014
R1-CEP 2010-316 - Rev 04
230MF10014
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
BACLOFEN
Baclofen
Baclofen at 19 Pellinska Str. 83-20...
Issue/Submission Date
2005-01-20
2021-03-03
2018-01-30
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USDMF

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CEP/COS

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Application Number
Status
 
Filing Details
Issue/Submission Date
Jai Radhe Sales

Biotechgate Digital

Not Confirmed

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USDMF

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CEP/COS

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Written Confirmation

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Application Number
6421
Status
Active
Fees Paid
N/A
 
Filing Details
BACLOFEN
Issue/Submission Date
1986-06-18
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USDMF

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CEP/COS

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Japanese DMF

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Application Number
7311
220MF10253
Status
Active
Fees Paid
Reviewed
 
Filing Details
BACLOFEN
Baclofen at NUERNBERGER STRASSE 12,...
Issue/Submission Date
1988-02-02
2008-12-12
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
7077
R1-CEP 2003-247 - Rev 01
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
BACLOFEN
Baclofen
Issue/Submission Date
1987-07-14
2020-07-30
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USDMF

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CEP/COS

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Application Number
Status
 
Filing Details
Issue/Submission Date
HRV Global Life Sciences Company Banner

Biotechgate Digital

Not Confirmed

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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
Status
 
Filing Details
Issue/Submission Date
Sigmak Lifesciences CB

Biotechgate Digital

Not Confirmed

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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
12541
Status
Active
Fees Paid
N/A
 
Filing Details
(R)-(-)-BACLOFEN
Issue/Submission Date
1997-04-17
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USDMF

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CEP/COS

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Application Number
35224
Status
Active
Fees Paid
N/A
 
Filing Details
BACLOFEN (PROCESS 2)
Issue/Submission Date
2020-10-16
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USDMF

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CEP/COS

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Japanese DMF

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Application Number
20885
Status
Active
Fees Paid
N/A
 
Filing Details
R-BACLOFEN
Issue/Submission Date
2007-09-25
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

Found WC

Application Number
33302
Indian CDSCO WC-0150A3-4
Status
Active
Fees Paid
Reviewed
 
Valid
2025-07-21
Filing Details
BACLOFEN USP
Baclofen USP/EP
Issue/Submission Date
2018-11-09
2022-07-15
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

Caution WC

Application Number
18220
R1-CEP 2006-229 - Rev 01
Indian CDSCO WC-0015
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-06-02
Filing Details
BACLOFEN USP
Baclofen
Baclofen USP/Ph. Eur
Issue/Submission Date
2005-03-30
2014-10-02
2019-06-03
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USDMF

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Application Number
30211
Status
Active
Fees Unpaid
N/A
 
Filing Details
PROPRIETARY MEDTRONIC NEUROMODULATI...
Issue/Submission Date
2016-01-21
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USDMF

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Application Number
38532
Status
Active
Fees Unpaid
Reviewed
 
Filing Details
BACLOFEN USP
Issue/Submission Date
2023-06-26
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USDMF

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Application Number
32431
Status
Active
Fees Paid
Reviewed
 
Filing Details
BACLOFEN USP
Issue/Submission Date
2018-03-07
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USDMF

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Application Number
9643
Status
Active
Fees Paid
N/A
 
Filing Details
LIORESAL INTRATHECAL AMPULS/BACLOFE...
Issue/Submission Date
1992-04-15
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USDMF

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Application Number
37011
Status
Active
Fees Unpaid
Reviewed
 
Filing Details
BACLOFEN USP
Issue/Submission Date
2022-04-27
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USDMF

Found USDMF

CEP/COS

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Japanese DMF

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Written Confirmation

Found WC

Application Number
28455
R1-CEP 2016-313 - Rev 00
Indian CDSCO WC-0123
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-02
Filing Details
BACLOFEN
Baclofen
Baclofen USP/EP
Issue/Submission Date
2014-07-31
2023-07-04
2022-06-29
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

Caution WC

Application Number
32923
CEP 2017-133 - Rev 01
Indian CDSCO WC-0381
Status
Active
Fees Unpaid
N/A
Valid
 
Expired
2023-08-23
Filing Details
3-(4-CHLOROPHENYL) GLUTARIC ANHYDRI...
Baclofen
Beclofen (USP/Ph. Eur./BP)
Issue/Submission Date
2018-07-06
2024-02-19
2020-08-17
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
35654
Indian CDSCO WC-0381n
Status
Active
Fees Unpaid
Reviewed
 
Expired
2023-08-23
Filing Details
BACLOFEN
Baclofen USP/EP/BP
Issue/Submission Date
2021-02-25
2020-08-17
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USDMF

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Application Number
7368
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
BACLOFEN
Issue/Submission Date
1988-03-08
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USDMF

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Application Number
7724
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
BACLOFEN RAW MATERIAL
Issue/Submission Date
1988-10-25
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USDMF

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Application Number
9837
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
BACLOFEN
Issue/Submission Date
1992-08-20
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USDMF

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Application Number
7817
Status
Inactive
Fees Paid
N/A
 
Filing Details
BACLOFEN
Issue/Submission Date
1988-12-15
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USDMF

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Application Number
22881
Status
Inactive
Fees Paid
N/A
 
Filing Details
R BACLOFEN
Issue/Submission Date
2009-06-22
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USDMF

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CEP/COS

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Application Number
7499
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
BACLOFEN
Issue/Submission Date
1988-05-26
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
R0-CEP 2018-280 - Rev 01
Status
Valid
 
Filing Details
Baclofen
Issue/Submission Date
2022-12-15
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USDMF

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CEP/COS

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Japanese DMF

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Application Number
R1-CEP 2011-360 - Rev 01
Status
Valid
 
Filing Details
Baclofen
Issue/Submission Date
2020-09-09
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USDMF

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CEP/COS

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Application Number
12438
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
BACLOFEN
Issue/Submission Date
1997-03-12
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Looking for 1134-47-0 / Baclofen API manufacturers, exporters & distributors?

Baclofen manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Baclofen API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Baclofen manufacturer or Baclofen supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Baclofen manufacturer or Baclofen supplier.

PharmaCompass also assists you with knowing the Baclofen API Price utilized in the formulation of products. Baclofen API Price is not always fixed or binding as the Baclofen Price is obtained through a variety of data sources. The Baclofen Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Baclofen

Synonyms

1134-47-0, Lioresal, 4-amino-3-(4-chlorophenyl)butanoic acid, Kemstro, Baclon, Dl-baclofen

Cas Number

1134-47-0

Unique Ingredient Identifier (UNII)

H789N3FKE8

About Baclofen

A GAMMA-AMINOBUTYRIC ACID derivative that is a specific agonist of GABA-B RECEPTORS. It is used in the treatment of MUSCLE SPASTICITY, especially that due to SPINAL CORD INJURIES. Its therapeutic effects result from actions at spinal and supraspinal sites, generally the reduction of excitatory transmission.

NCGC00024579-04 Manufacturers

A NCGC00024579-04 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of NCGC00024579-04, including repackagers and relabelers. The FDA regulates NCGC00024579-04 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. NCGC00024579-04 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 NCGC00024579-04 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

NCGC00024579-04 Suppliers

A NCGC00024579-04 supplier is an individual or a company that provides NCGC00024579-04 active pharmaceutical ingredient (API) or NCGC00024579-04 finished formulations upon request. The NCGC00024579-04 suppliers may include NCGC00024579-04 API manufacturers, exporters, distributors and traders.

click here to find a list of NCGC00024579-04 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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