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List of Drug Master Files (KDMF) for Apremilast Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 Dr. Reddy's Laboratories Limited (1)

02 Neuland Laboratories Limited (Unit-II) (1)

03 Celgene Chemicals GmbH@Siegfried Ltd (1)

04 Glenmark Life Sciences Ltd (1)

05 Hetero Drugs Limited (Unit-I) (1)

06 Lonza AG (1)

07 Lupine Limited (1)

08 M/S. Aurobindo Pharma Limited, Unit-XI (1)

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01 Aging Life Science Co., Ltd. (1)

02 Amgen Korea Limited (2)

03 Kookjeon Pharmaceutical Co., Ltd. (1)

04 Leesung International Co., Ltd. (1)

05 Mpeak Korea Co., Ltd. (1)

06 Sangjin Trading Co., Ltd. (1)

07 UN Generic Co., Ltd. (1)

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01 Apremilast (7)

02 Apremilast (micronized) (1)

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01 India (6)

02 U.S.A (2)

Sangjin Trading Co., Ltd.
2022-06-22
Number 583-31-ND
Dr. Reddy's Laboratories ...
India
CTO-SEZ Process Unit-01, ...
Aging Life Science Co., Ltd.
2020-12-17
Number 434-25-ND
Neuland Laboratories Limi...
India
Plot Nos. 92, 93, 94, 257...
URL Supplier Web Content
Kookjeon Pharmaceutical Co., Ltd.
2022-09-06
Number 173-42-ND
M/S. Aurobindo Pharma Lim...
India
Survey Nos. 1/22, 2/1 to ...
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Amgen Korea Limited
2017-08-17
Wed 17-9-ND
Celgene Chemicals GmbH@Si...
U.S.A
Untere Bruhlstrasse 4, 48...
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Mpeak Korea Co., Ltd.
2020-11-06
Wed812-13-ND
Glenmark Life Sciences Lt...
India
Plot No.Z-103/ I, DAHEJ S...
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Leesung International Co., Ltd.
2020-12-17
Wed21-17-ND
Hetero Drugs Limited (Uni...
India
Sy. No.213, 214 & 255, Bo...
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Amgen Korea Limited
2017-08-11
Wed 17-8-ND
Lonza AG
Switzerland
Chemie, Lonzastrasse, 393...
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UN Generic Co., Ltd.
2022-11-18
Number 827-4-ND
Lupine Limited
India
Block No.21, Dabhasa, Tal...
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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 KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Apremilast Drug Master File in Korea (Apremilast KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Apremilast. The MFDS reviews the Apremilast KDMF as part of the drug registration process and uses the information provided in the Apremilast KDMF to evaluate the safety and efficacy of the drug.

After submitting a Apremilast KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Apremilast API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Apremilast suppliers with KDMF on PharmaCompass.

Apremilast Manufacturers | Traders | Suppliers

Apremilast Manufacturers, Traders, Suppliers 1
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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