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

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01 Megafine Pharma (P) Limited (1)

02 Polpharma (1)

03 Metrochem API Private Limited (1)

04 Dr. Reddy's Laboratories (2)

05 Aarti Pharmalabs (1)

06 Neuland Laboratories (1)

07 HRV Global Life Sciences (1)

08 Shandong Loncom Pharmaceutical (1)

09 Shandong Boyuan Pharmaceutical (1)

10 Alembic Pharmaceuticals Limited (2)

11 Alkem Laboratories (1)

12 Arene Lifesciences (1)

13 Aurobindo Pharma Limited (1)

14 Beijing Mesochem Technology (1)

15 Bulat Pharmaceutical (1)

16 CHEMO (1)

17 Changzhou Pharmaceutical Factory (1)

18 Cipla (2)

19 DEAFARMA (1)

20 Deva Holding AS (1)

21 Enantiotech (1)

22 Farmak JSC (1)

23 Glenmark Life Sciences (1)

24 Glenmark Pharmaceuticals (1)

25 Globofarm International (1)

26 Guangzhou Topwork Chemical (1)

27 Guangzhou Tosun Pharmaceutical (1)

28 HEC Pharm (1)

29 Hainan Poly Pharm (1)

30 Hangzhou Longshine Bio-Tech (1)

31 Haoyuan Chemexpress Co.Ltd (1)

32 Hetero Drugs (1)

33 Intas Pharmaceuticals (1)

34 Jubilant Generics (1)

35 Kukjeon Pharmaceutical (1)

36 Laxmidas Dahyabhai & Co (1)

37 Lek Pharmaceuticals (1)

38 Lewens Labs (1)

39 Lupin Ltd (2)

40 MSN Laboratories (4)

41 Macleods Pharmaceuticals Limited (1)

42 Omgene Life Sciences (1)

43 Piramal Pharma Solutions (1)

44 Quimica Sintetica S.A. (2)

45 Raks Pharma (1)

46 ScinoPharm Taiwan, Ltd (1)

47 Srini Pharmaceuticals (1)

48 Sun Pharmaceutical Industries Limited (1)

49 Sun-shine Chem (1)

50 Teva Pharmaceutical Industries (1)

51 Unichem Laboratories Limited (1)

52 Viatris (1)

53 Zhejiang Ausun Pharmaceutical (1)

54 Zhejiang Huahai Pharmaceutical (1)

55 Zhejiang Huayi Pharmaceutical Co., Ltd. (1)

56 Zydus Lifesciences (1)

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01 China (15)

02 India (36)

03 Israel (1)

04 Italy (1)

05 Poland (1)

06 Slovenia (1)

07 South Korea (1)

08 Spain (3)

09 Taiwan (1)

10 Turkey (1)

11 U.S.A (2)

12 Ukraine (1)

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01 Active (34)

02 Inactive (1)

03 Blank (29)

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01 Blank (64)

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01 Blank (64)

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01 WC-0037 (1)

02 WC-0049 (1)

03 WC-0082 (1)

04 WC-0087-(Annexure-2) (1)

05 WC-0310A3-4 (1)

06 WC-0383A4 (1)

07 WC-390A4 (1)

08 Blank (57)

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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
Indian CDSCO WC-0087-(Annexure-2)
Status
 
Valid
2025-07-21
Filing Details
Apremilast IHS
Issue/Submission Date
2023-08-28
Megafine Pharma CB

Swiss Biotech Day

Not Confirmed

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USDMF

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Japanese DMF

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Written Confirmation

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Application Number
31141
Status
Active
Fees Paid
Reviewed
 
Filing Details
APREMILAST
Issue/Submission Date
2016-11-09
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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
30732
Indian CDSCO WC-390A4
Status
Active
Fees Paid
Reviewed
 
Valid
2025-11-30
Filing Details
APREMILAST (FORM B)
Apremilast IH
Issue/Submission Date
2016-09-30
2022-09-30
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USDMF

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CEP/COS

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Written Confirmation

Found WC

Application Number
32953
Indian CDSCO WC-0037
Status
Active
Fees Paid
N/A
 
Valid
2025-06-16
Filing Details
APREMILAST
Apremilast IH
Issue/Submission Date
2018-11-06
2022-06-08
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USDMF

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

Swiss Biotech Day

Not Confirmed

envelop Contact Supplier
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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
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USDMF

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Application Number
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Filing Details
Issue/Submission Date
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USDMF

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CEP/COS

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Application Number
31356
Status
Active
Fees Paid
Reviewed
 
Filing Details
APREMILAST [AMORPHOUS]
Issue/Submission Date
2017-06-02
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USDMF

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CEP/COS

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Application Number
31180
Status
Active
Fees Paid
Reviewed
 
Filing Details
APREMILAST
Issue/Submission Date
2016-12-29
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USDMF

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Written Confirmation

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Application Number
39101
Status
Active
Fees Paid
N/A
 
Filing Details
APREMILAST
Issue/Submission Date
2023-12-12
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USDMF

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Written Confirmation

Caution WC

Application Number
30332
Indian CDSCO WC-0383A4
Status
Active
Fees Paid
Reviewed
 
Expired
2022-08-08
Filing Details
APREMILAST [ROUTE CODE LI]
Apremilast IH
Issue/Submission Date
2016-03-29
2019-10-15
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USDMF

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Application Number
30866
Status
Active
Fees Paid
Reviewed
 
Filing Details
APREMILAST (FORM-M)
Issue/Submission Date
2016-08-31
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USDMF

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Application Number
31159
Status
Active
Fees Paid
Reviewed
 
Filing Details
APREMILAST (AMORPHOUS)
Issue/Submission Date
2016-12-23
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USDMF

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Application Number
31360
Status
Active
Fees Paid
Reviewed
 
Filing Details
APREMILAST
Issue/Submission Date
2017-02-28
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USDMF

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Written Confirmation

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Application Number
32149
Status
Active
Fees Paid
Reviewed
 
Filing Details
APREMILAST
Issue/Submission Date
2017-10-18
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USDMF

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Written Confirmation

Found WC

Application Number
30248
Indian CDSCO WC-0049
Status
Active
Fees Paid
Reviewed
 
Valid
2025-06-16
Filing Details
APREMILAST
Apremilast ih
Issue/Submission Date
2016-04-06
2022-06-07
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USDMF

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Application Number
31266
Status
Active
Fees Paid
Reviewed
 
Filing Details
APREMILAST (FORM M)
Issue/Submission Date
2017-03-22
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USDMF

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Application Number
32373
Status
Active
Fees Paid
Reviewed
 
Filing Details
APREMILAST
Issue/Submission Date
2017-12-22
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USDMF

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Application Number
34088
Status
Active
Fees Paid
N/A
 
Filing Details
APREMILAST NON-STERILE BULK DRUG SU...
Issue/Submission Date
2019-08-31
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USDMF

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Application Number
32119
Status
Active
Fees Paid
Reviewed
 
Filing Details
APREMILAST
Issue/Submission Date
2017-10-10
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USDMF

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Application Number
34915
Status
Active
Fees Paid
Reviewed
 
Filing Details
APREMILAST (PROCESS II)
Issue/Submission Date
2020-06-17
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USDMF

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Application Number
31882
Status
Active
Fees Paid
Reviewed
 
Filing Details
APREMILAST
Issue/Submission Date
2017-07-12
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USDMF

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Application Number
31809
Status
Active
Fees Unpaid
Reviewed
 
Filing Details
APREMILAST
Issue/Submission Date
2017-09-27
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USDMF

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Application Number
32473
Status
Active
Fees Paid
Reviewed
 
Filing Details
APREMILAST
Issue/Submission Date
2018-07-16
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USDMF

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Caution WC

Application Number
31490
Indian CDSCO WC-0310A3-4
Status
Active
Fees Unpaid
Reviewed
 
Expired
2023-11-23
Filing Details
APREMILAST
Apremilast IH
Issue/Submission Date
2017-03-31
2022-05-27
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USDMF

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Application Number
34447
Status
Active
Fees Paid
N/A
 
Filing Details
APREMILAST
Issue/Submission Date
2020-01-17
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Application Number
32058
Status
Active
Fees Paid
N/A
 
Filing Details
APREMILAST
Issue/Submission Date
2017-11-13
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USDMF

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Application Number
31844
Status
Active
Fees Unpaid
N/A
 
Filing Details
AMT01 (INTERMEDIATE FOR APREMILAST)
Issue/Submission Date
2017-06-15
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Looking for 608141-41-9 / Apremilast API manufacturers, exporters & distributors?

Apremilast manufacturers, exporters & distributors 1

22

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

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

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

API | Excipient name

Apremilast

Synonyms

608141-41-9, Otezla, Cc-10004, Cc 10004, Apremilast (cc-10004), Cc10004

Cas Number

608141-41-9

Unique Ingredient Identifier (UNII)

UP7QBP99PN

About Apremilast

Apremilast is an orally bioavailable, small molecule inhibitor of phosphodiesterase 4 (PDE4), with potential anti-inflammatory activity. Upon oral administration, apremilast targets, binds to and inhibits the activity of PDE4, thereby blocking cyclic adenosine monophosphate (cAMP) degradation and increasing intracellular cAMP levels. This may decrease the production of the proinflammatory cytokines including tumor necrosis factor-alpha (TNF-alpha). PDE4 is an enzyme that plays an important role in the degradation of cAMP and in cytokine production in inflammatory cells.

Apremilast Manufacturers

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

Apremilast Suppliers

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

click here to find a list of Apremilast 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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