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

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01 Apitoria Pharma Private Limited, Unit-I@Aurobindo Pharma Limited (1)

02 Assia Chemical Industries Ltd. (Teva Tech site) (1)

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01 JW Pharmaceutical Co., Ltd. (1)

02 Seongui Bio Co., Ltd. (1)

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01 Modafinil (2)

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01 India (1)

02 Israel (1)

URL Supplier Web Content
JW Pharmaceutical Co., Ltd.
2023-05-11
20230511-209-J-1490
Assia Chemical Industries...
Israel
Neot-Hovav Eco-Ind. Park,...
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URL Supplier Web Content
Seongui Bio Co., Ltd.
2020-02-27
20200227-209-J-317
Apitoria Pharma Private L...
India
Sy.No. 379, 385, 386, 388...
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Looking for 68693-11-8 / Modafinil API manufacturers, exporters & distributors?

Modafinil manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Modafinil

Synonyms

68693-11-8, Provigil, Modiodal, 2-[(diphenylmethyl)sulfinyl]acetamide, Modafinilum [latin], 2-(benzhydrylsulfinyl)acetamide

Cas Number

68693-11-8

Unique Ingredient Identifier (UNII)

R3UK8X3U3D

About Modafinil

A benzhydryl acetamide compound, central nervous system stimulant, and CYP3A4 inducing agent that is used in the treatment of NARCOLEPSY and SLEEP WAKE DISORDERS.

Modafinil Manufacturers

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

Modafinil Suppliers

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

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

Modafinil KDMF

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

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

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

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

Modafinil Manufacturers | Traders | Suppliers

Modafinil Manufacturers, Traders, Suppliers 1
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We have 2 companies offering Modafinil

Get in contact with the supplier of your choice:

  1. Assia Chemical Industries Ltd
  2. Aurobindo Pharma Limited
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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