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API SUPPLIERS
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
EU-WC
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USDMF
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-05
Pay. Date : 2014-01-22
DMF Number : 24945
Submission : 2011-06-01
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
Date of Issue : 2024-04-23
Valid Till : 2027-04-22
Written Confirmation Number : WC-0170
Address of the Firm : Plot No. 41, 42/2, 42/1/B, 43, 40, 59, 58 GIDC, Vapi, Dist: Valsad -396195, Guja...
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Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Modafinil \"Orion\"
Dosage Form : Tablet
Dosage Strength : 100mg
Packaging :
Approval Date : 26-11-2015
Application Number : 28105501014
Regulatory Info : Prescription
Registration Country : Denmark
Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Modafinil \"Orion\"
Dosage Form : Tablet
Dosage Strength : 200mg
Packaging :
Approval Date : 26-11-2015
Application Number : 28105501114
Regulatory Info : Prescription
Registration Country : Denmark
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - TABLET;ORAL - 100MG **Federal Regist...DOSAGE - TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21875
DOSAGE - TABLET;ORAL - 150MG
USFDA APPLICATION NUMBER - 21875
DOSAGE - TABLET;ORAL - 200MG
USFDA APPLICATION NUMBER - 21875
DOSAGE - TABLET;ORAL - 250MG
USFDA APPLICATION NUMBER - 21875
DOSAGE - TABLET;ORAL - 50MG
USFDA APPLICATION NUMBER - 21875
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REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
17
PharmaCompass offers a list of Armodafinil API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Armodafinil manufacturer or Armodafinil supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Armodafinil manufacturer or Armodafinil supplier.
A Armodafinil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Armodafinil, including repackagers and relabelers. The FDA regulates Armodafinil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Armodafinil 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 Armodafinil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Armodafinil supplier is an individual or a company that provides Armodafinil active pharmaceutical ingredient (API) or Armodafinil finished formulations upon request. The Armodafinil suppliers may include Armodafinil API manufacturers, exporters, distributors and traders.
click here to find a list of Armodafinil suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Armodafinil DMF (Drug Master File) is a document detailing the whole manufacturing process of Armodafinil active pharmaceutical ingredient (API) in detail. Different forms of Armodafinil DMFs exist exist since differing nations have different regulations, such as Armodafinil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Armodafinil DMF submitted to regulatory agencies in the US is known as a USDMF. Armodafinil USDMF includes data on Armodafinil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Armodafinil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Armodafinil suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Armodafinil Drug Master File in Korea (Armodafinil KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Armodafinil. The MFDS reviews the Armodafinil KDMF as part of the drug registration process and uses the information provided in the Armodafinil KDMF to evaluate the safety and efficacy of the drug.
After submitting a Armodafinil 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 Armodafinil API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Armodafinil suppliers with KDMF on PharmaCompass.
A Armodafinil written confirmation (Armodafinil WC) is an official document issued by a regulatory agency to a Armodafinil manufacturer, verifying that the manufacturing facility of a Armodafinil active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Armodafinil APIs or Armodafinil finished pharmaceutical products to another nation, regulatory agencies frequently require a Armodafinil WC (written confirmation) as part of the regulatory process.
click here to find a list of Armodafinil suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Armodafinil as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Armodafinil API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Armodafinil as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Armodafinil and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Armodafinil NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Armodafinil suppliers with NDC on PharmaCompass.
Armodafinil Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Armodafinil GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Armodafinil GMP manufacturer or Armodafinil GMP API supplier for your needs.
A Armodafinil CoA (Certificate of Analysis) is a formal document that attests to Armodafinil's compliance with Armodafinil specifications and serves as a tool for batch-level quality control.
Armodafinil CoA mostly includes findings from lab analyses of a specific batch. For each Armodafinil CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Armodafinil may be tested according to a variety of international standards, such as European Pharmacopoeia (Armodafinil EP), Armodafinil JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Armodafinil USP).
