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

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01 Seqens (1)

02 Alembic Pharmaceuticals Limited (1)

03 Amino Chemicals (1)

04 Aurobindo Pharma Limited (1)

05 CEPHALON INC (1)

06 Chromo Laboratories (1)

07 Dipharma (1)

08 Flamma SpA (1)

09 Helsinn Advanced Synthesis (1)

10 Orchid Pharma (1)

11 Sun Pharmaceutical Industries Limited (1)

12 Teva API (1)

13 UQUIFA (1)

14 Viatris (1)

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01 (R)-MODAFINIL (1)

02 MODAFINIL (7)

03 MODAFINIL DRUG SUBSTANCE (1)

04 MODAFINIL USP (4)

05 MODAFINIL USP (NON-STERILE DRUG SUBSTANCE) (1)

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01 France (1)

02 India (5)

03 Israel (1)

04 Italy (2)

05 Malta (1)

06 Spain (1)

07 Switzerland (1)

08 U.S.A (2)

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01 Active (9)

02 Inactive (5)

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01 Complete (2)

02 Blank (12)

URL Supplier Web Content
16477
Active
2003-03-21
N/A
II
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23898
Active
2010-06-29
Complete
2013-09-29
2013-09-23
II
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11970
Active
1996-05-15
N/A
II
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36975
Active
2022-04-23
N/A
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URL Supplier Web Content
16250
Active
2002-11-19
Complete
2016-07-28
2016-07-05
II
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19645
Active
2006-08-03
N/A
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16310
Active
2002-12-13
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17545
Inactive
2004-07-19
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URL Supplier Web Content
16306
Active
2002-12-12
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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 USDMF

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

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

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

Modafinil Manufacturers | Traders | Suppliers

Modafinil 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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