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List of Drug Master Files (DMF) of Apremilast Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Polpharma (1)

02 Dr. Reddy's Laboratories (2)

03 Neuland Laboratories (1)

04 Alembic Pharmaceuticals Limited (2)

05 Alkem Laboratories (1)

06 Aurobindo Pharma Limited (1)

07 Changzhou Pharmaceutical Factory (1)

08 Cipla (1)

09 Enantiotech (1)

10 Glenmark Life Sciences (1)

11 HEC Pharm (1)

12 Hainan Poly Pharm (1)

13 Hetero Drugs (1)

14 Intas Pharmaceuticals (1)

15 Jubilant Generics (1)

16 Lek Pharmaceuticals (1)

17 Lupin Ltd (2)

18 MSN Laboratories (4)

19 Macleods Pharmaceuticals Limited (1)

20 Quimica Sintetica S.A. (2)

21 Raks Pharma (1)

22 ScinoPharm Taiwan, Ltd (1)

23 Sun Pharmaceutical Industries Limited (1)

24 Unichem Laboratories Limited (1)

25 Viatris (1)

26 Zhejiang Huahai Pharmaceutical (1)

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

28 Zydus Lifesciences (1)

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01 AMT01 (INTERMEDIATE FOR APREMILAST) (1)

02 APREMILAST (22)

03 APREMILAST (AMORPHOUS) (2)

04 APREMILAST (CRYSTALLINE) (1)

05 APREMILAST (FORM B) (1)

06 APREMILAST (FORM M) (1)

07 APREMILAST (FORM-B) (2)

08 APREMILAST (FORM-M) (1)

09 APREMILAST (PROCESS II) (1)

10 APREMILAST NON-STERILE BULK DRUG SUBSTANCE (1)

11 APREMILAST [AMORPHOUS] (1)

12 APREMILAST [ROUTE CODE LI] (1)

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01 China (6)

02 India (23)

03 Poland (1)

04 Slovenia (1)

05 Spain (2)

06 Taiwan (1)

07 U.S.A (1)

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01 Active (34)

02 Inactive (1)

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01 Complete (25)

02 Blank (10)

URL Supplier Web Content
31266
Active
2017-03-22
Complete
2017-06-09
2017-05-25
II
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URL Supplier Web Content
30248
Active
2016-04-06
Complete
2016-04-24
2016-04-04
II
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URL Supplier Web Content
30332
Active
2016-03-29
Complete
2017-02-03
2016-09-29
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URL Supplier Web Content
31159
Active
2016-12-23
Complete
2018-03-20
2017-10-10
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URL Supplier Web Content
30866
Active
2016-08-31
Complete
2017-11-17
2017-10-10
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URL Supplier Web Content
31180
Active
2016-12-29
Complete
2017-02-01
2016-12-27
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Looking for 608141-41-9 / Apremilast API manufacturers, exporters & distributors?

Apremilast manufacturers, exporters & distributors 1

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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.

Apremilast USDMF

A Apremilast DMF (Drug Master File) is a document detailing the whole manufacturing process of Apremilast active pharmaceutical ingredient (API) in detail. Different forms of Apremilast DMFs exist exist since differing nations have different regulations, such as Apremilast USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Apremilast DMF submitted to regulatory agencies in the US is known as a USDMF. Apremilast USDMF includes data on Apremilast's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Apremilast USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Apremilast suppliers with USDMF 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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