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

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01 Synnat Pharma (1)

02 Metrochem API Private Limited (1)

03 Dr. Reddy's Laboratories (1)

04 LGM Pharma (1)

05 HRV Global Life Sciences (1)

06 Tofigh Daru (1)

07 Alembic Pharmaceuticals Limited (2)

08 Alkaloids Corporation (1)

09 Amuna Pharmaceuticals (1)

10 Apotex Pharmachem (1)

11 Aragen Life Sciences (1)

12 Aspire Lifesciences Pvt Ltd (1)

13 Biocon (1)

14 Biotechnica DWC (1)

15 CHEMO (1)

16 Danesh Kimia Pharmed (1)

17 Deva Holding AS (1)

18 Emcure Pharmaceuticals (1)

19 Enaltec Labs Private Limited (1)

20 Estechpharma (1)

21 Glenmark Life Sciences (1)

22 Glenmark Pharmaceuticals (1)

23 Guangzhou Tosun Pharmaceutical (1)

24 HEC Pharm (1)

25 HONOUR LAB LTD (1)

26 Hetero Drugs (1)

27 Intas Pharmaceuticals (1)

28 KIVIPharm (1)

29 MSN Laboratories (3)

30 Maprimed S.A. (1)

31 Novugen (1)

32 Prajna Generics (1)

33 Shilpa Medicare (2)

34 Sun Pharmaceutical Industries Limited (1)

35 Synthon Pharmaceuticals (1)

36 Tai Heng Industry Co., Ltd (1)

37 Teva API (1)

38 Teva Pharmaceutical Industries (1)

39 Viatris (1)

40 Zhejiang Huahai Pharmaceutical (1)

41 Zydus Lifesciences (1)

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01 Algeria (1)

02 Argentina (1)

03 Canada (1)

04 China (5)

05 India (25)

06 Iran (2)

07 Israel (2)

08 Netherlands (1)

09 South Korea (1)

10 Spain (1)

11 Turkey (1)

12 U.A.E (1)

13 U.S.A (3)

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01 Active (20)

02 Blank (25)

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01 Valid (14)

02 Blank (31)

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01 304MF10011 (1)

02 Blank (44)

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01 WC-0057n (1)

02 WC-0067n (1)

03 WC-0082 (1)

04 WC-0082A12-A13 (1)

05 WC-0147 (1)

06 WC-0147A3 (1)

07 WC-0157 (1)

08 WC-0226 (1)

09 WC-0349 (1)

10 WC-0349A5-A6 (1)

11 WC-0349A9 (1)

12 WC-0362 (1)

13 Blank (33)

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USDMF

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Application Number
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USDMF

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Written Confirmation

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Application Number
Indian CDSCO WC-0067n
Status
 
Valid
2025-07-07
Filing Details
Fingolimod Hydrochloride IH
Issue/Submission Date
2022-06-17
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USDMF

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

Cophex 2024

Not Confirmed

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USDMF

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Application Number
28278
Status
Active
Fees Paid
Reviewed
 
Filing Details
FINGOLIMOD HYDROCHLORIDE USP
Issue/Submission Date
2014-06-11
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USDMF

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Written Confirmation

Caution WC

Application Number
28162
R0-CEP 2019-145 - Rev 01
Indian CDSCO WC-0147
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-07-02
Filing Details
FINGOLIMOD HYDROCHLORIDE
Fingolimod hydrochloride
Fingolimod Hydrochloride IH
Issue/Submission Date
2014-05-30
2022-07-21
2019-07-05
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USDMF

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CEP/COS

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Written Confirmation

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Application Number
28322
R0-CEP 2020-312 - Rev 00
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
FINGOLIMOD HYDROCHLORIDE (CODE 5099...
Fingolimod hydrochloride
Issue/Submission Date
2014-07-08
2021-10-28
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USDMF

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Application Number
28148
Status
Active
Fees Paid
Reviewed
 
Filing Details
FINGOLIMOD HYDROCHLORIDE
Issue/Submission Date
2014-04-27
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USDMF

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Written Confirmation

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Application Number
28142
Status
Active
Fees Unpaid
Reviewed
 
Filing Details
FINGOLIMOD HYDROCHLORIDE
Issue/Submission Date
2014-04-23
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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
28225
R0-CEP 2019-171 - Rev 01
Indian CDSCO WC-0362
Status
Active
Fees Unpaid
Reviewed
Valid
 
Expired
2022-05-05
Filing Details
FINGOLIMOD HYDROCHLORIDE
Fingolimod hydrochloride
Fingolimod Hydrochloride (IH)
Issue/Submission Date
2014-04-22
2023-07-27
2019-07-26
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USDMF

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Application Number
27983
Status
Active
Fees Paid
Reviewed
 
Filing Details
FINGOLIMOD HYDROCHLORIDE
Issue/Submission Date
2014-03-28
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USDMF

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Japanese DMF

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Written Confirmation

Found WC

Application Number
28057
R0-CEP 2019-301 - Rev 01
Indian CDSCO WC-0082
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-02
Filing Details
FINGOLIMOD HYDROCHLORIDE USP
Fingolimod hydrochloride
Fingolimod Hydrochloride IH
Issue/Submission Date
2014-03-28
2022-11-18
2022-06-17
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USDMF

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CEP/COS

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Written Confirmation

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Application Number
27830
R0-CEP 2019-290 - Rev 01
Indian CDSCO WC-0349
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-05-05
Filing Details
FINGOLIMOD HYDROCHLORIDE USP [ROUTE...
Fingolimod hydrochloride
Fingolimod Hydrochloride (IHS)
Issue/Submission Date
2013-12-30
2023-08-11
2022-09-02
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USDMF

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CEP/COS

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Written Confirmation

Caution WC

Application Number
32390
R0-CEP 2021-066 - Rev 01
Indian CDSCO WC-0349A9
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-05-05
Filing Details
FINGOLIMOD
Fingolimod hydrochloride, Form-I
Fingolimod HCl EP
Issue/Submission Date
2017-12-30
2023-08-11
2020-09-30
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USDMF

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Written Confirmation

Caution WC

Application Number
32542
Indian CDSCO WC-0349A5-A6
Status
Active
Fees Paid
N/A
 
Expired
2022-05-05
Filing Details
FINGOLIMOD HYDROCHLORIDE USP (FORM-...
Fingolimod IH
Issue/Submission Date
2018-03-01
2019-10-07
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USDMF

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Written Confirmation

Caution WC

Application Number
28235
Indian CDSCO WC-0226
Status
Active
Fees Paid
Reviewed
 
Expired
2022-07-02
Filing Details
FINGOLIMOD HYDROCHLORIDE USP
Fingolimod Hydrochloride IH
Issue/Submission Date
2014-06-19
2019-10-07
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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
28165
R0-CEP 2019-140 - Rev 00
304MF10011
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
FINGOLIMOD HYDROCHLORIDE NON-STERIL...
Fingolimod hydrochloride, Form-I
Fingolimod Hydrochloride at Xiaba D...
Issue/Submission Date
2014-04-23
2021-07-15
2022-01-13
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USDMF

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Application Number
28372
Status
Active
Fees Paid
Reviewed
 
Filing Details
FINGOLIMOD HYDROCHLORIDE USP
Issue/Submission Date
2014-06-19
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Application Number
28303
Status
Active
Fees Paid
Reviewed
 
Filing Details
FINGOLIMOD HYDROCHLORIDE USP
Issue/Submission Date
2014-07-10
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USDMF

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Written Confirmation

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Application Number
28276
CEP 2020-156 - Rev 02
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
FINGOLIMOD HYDROCHLORIDE
Fingolimod hydrochloride
Issue/Submission Date
2014-06-11
2023-09-15
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USDMF

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Application Number
33328
Status
Active
Fees Unpaid
Reviewed
 
Filing Details
FINGOLIMOD HYDROCHLORIDE USP
Issue/Submission Date
2018-12-24
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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
28387
R0-CEP 2020-090 - Rev 01
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
FINGOLIMOD HYDROCHLORIDE (FORM 1)
Fingolimod hydrochloride
Issue/Submission Date
2014-06-24
2023-07-05
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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
26807
R0-CEP 2020-108 - Rev 00
Indian CDSCO WC-0057n
Status
Active
Fees Unpaid
Reviewed
Valid
 
Valid
2025-06-25
Filing Details
FINGOLIMOD HYDROCHLORIDE USP
Fingolimod hydrochloride
Fingolimod Hydrochloride (1H)
Issue/Submission Date
2013-02-20
2022-06-30
2022-06-07
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USDMF

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Application Number
R0-CEP 2020-352 - Rev 00
Status
Valid
 
Filing Details
Fingolimod hydrochloride
Issue/Submission Date
2022-05-03
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Application Number
R0-CEP 2018-259 - Rev 02
Status
Valid
 
Filing Details
Fingolimod hydrochloride
Issue/Submission Date
2022-02-04
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Caution WC

Application Number
Indian CDSCO WC-0147A3
Status
 
Expired
2022-07-02
Filing Details
Fingolimod HCl EP/USP
Issue/Submission Date
2021-06-11
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Application Number
Indian CDSCO WC-0082A12-A13
Status
 
Expired
2022-07-02
Filing Details
Fingolimod HCl EP
Issue/Submission Date
2021-12-02
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Application Number
R0-CEP 2020-220 - Rev 00
Status
Valid
 
Filing Details
Fingolimod hydrochloride
Issue/Submission Date
2021-04-29
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Looking for 162359-56-0 / Fingolimod Hydrochloride API manufacturers, exporters & distributors?

Fingolimod Hydrochloride manufacturers, exporters & distributors 1

47

PharmaCompass offers a list of Fingolimod Hydrochloride 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 Fingolimod Hydrochloride manufacturer or Fingolimod Hydrochloride supplier for your needs.

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

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

API | Excipient name

Fingolimod Hydrochloride

Synonyms

162359-56-0, Fty720, Fingolimod hcl, Gilenia, Gilenya, Fty 720

Cas Number

162359-56-0

Unique Ingredient Identifier (UNII)

G926EC510T

About Fingolimod Hydrochloride

A sphingosine-derivative and IMMUNOSUPPRESSIVE AGENT that blocks the migration and homing of LYMPHOCYTES to the CENTRAL NERVOUS SYSTEM through its action on SPHINGOSINE 1-PHOSPHATE RECEPTORS. It is used in the treatment of MULTIPLE SCLEROSIS.

Fingolimod Manufacturers

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

Fingolimod Suppliers

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

click here to find a list of Fingolimod 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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