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

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01 Chongqing Huapont Shengchem Pharmaceutical Co., Ltd. (1)

02 Gukjeon Pharmaceutical Co., Ltd.@[Zhebang Pharmaceutical Co., Ltd.] Zhejiang Zhebang Pharmaceutical Co.,Ltd. (1)

03 Shanghai New Hualian Pharmaceutical Co.,Ltd (1)

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01 Ace Biopharm Co., Ltd. (1)

02 Eltech Pharmachem Co., Ltd. (1)

03 Kookjeon Pharmaceutical Co., Ltd. (1)

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01 Isotretinoin (3)

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01 China (2)

02 South Korea (1)

URL Supplier Web Content
Ace Biopharm Co., Ltd.
2017-12-26
20171226-209-J-4
Chongqing Huapont Shengch...
China
No. 666 Rongjun Road, Nan...
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URL Supplier Web Content
Kookjeon Pharmaceutical Co., Ltd.
2019-03-27
20190327-209-J-207
Gukjeon Pharmaceutical Co...
South Korea
8@No.3 , Balangongdan-ro,...
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Eltech Pharmachem Co., Ltd.
2018-07-12
20180712-209-J-72
Shanghai New Hualian Phar...
China
No.217, Minle Road, Devel...
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Looking for 4759-48-2 / Isotretinoin API manufacturers, exporters & distributors?

Isotretinoin manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Isotretinoin

Synonyms

4759-48-2, 13-cis-retinoic acid, Accutane, Roaccutane, Claravis, Neovitamin a acid

Cas Number

4759-48-2

Unique Ingredient Identifier (UNII)

EH28UP18IF

About Isotretinoin

A topical dermatologic agent that is used in the treatment of ACNE VULGARIS and several other skin diseases. The drug has teratogenic and other adverse effects.

Isotretinoin Manufacturers

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

Isotretinoin Suppliers

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

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

Isotretinoin KDMF

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

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

After submitting a Isotretinoin 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 Isotretinoin API can apply through the Korea Drug Master File (KDMF).

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

Isotretinoin Manufacturers | Traders | Suppliers

Isotretinoin Manufacturers, Traders, Suppliers 1
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We have 3 companies offering Isotretinoin

Get in contact with the supplier of your choice:

  1. Chongqing Huapont Pharmaceutical
  2. Kukjeon Pharmaceutical
  3. Shanghai Pharma Group
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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