Synopsis
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CEP/COS
0
JDMF
0
EU WC
0
KDMF
0
VMF
0
FDF
0
Europe
0
Canada
0
Australia
0
South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 1.2...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 1.25MG;1.25MG;1.25MG;1.25MG
USFDA APPLICATION NUMBER - 21303
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 2.5...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 2.5MG;2.5MG;2.5MG;2.5MG
USFDA APPLICATION NUMBER - 21303
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 3.7...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 3.75MG;3.75MG;3.75MG;3.75MG
USFDA APPLICATION NUMBER - 21303
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 5MG...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 5MG;5MG;5MG;5MG
USFDA APPLICATION NUMBER - 21303
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 6.2...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 6.25MG;6.25MG;6.25MG;6.25MG
USFDA APPLICATION NUMBER - 21303
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 7.5...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 7.5MG;7.5MG;7.5MG;7.5MG
USFDA APPLICATION NUMBER - 21303
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Dextroamphetamine Saccharate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dextroamphetamine Saccharate, including repackagers and relabelers. The FDA regulates Dextroamphetamine Saccharate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dextroamphetamine Saccharate 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 Dextroamphetamine Saccharate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dextroamphetamine Saccharate supplier is an individual or a company that provides Dextroamphetamine Saccharate active pharmaceutical ingredient (API) or Dextroamphetamine Saccharate finished formulations upon request. The Dextroamphetamine Saccharate suppliers may include Dextroamphetamine Saccharate API manufacturers, exporters, distributors and traders.
click here to find a list of Dextroamphetamine Saccharate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dextroamphetamine Saccharate DMF (Drug Master File) is a document detailing the whole manufacturing process of Dextroamphetamine Saccharate active pharmaceutical ingredient (API) in detail. Different forms of Dextroamphetamine Saccharate DMFs exist exist since differing nations have different regulations, such as Dextroamphetamine Saccharate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dextroamphetamine Saccharate DMF submitted to regulatory agencies in the US is known as a USDMF. Dextroamphetamine Saccharate USDMF includes data on Dextroamphetamine Saccharate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dextroamphetamine Saccharate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dextroamphetamine Saccharate suppliers with USDMF 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 Dextroamphetamine Saccharate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dextroamphetamine Saccharate 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 Dextroamphetamine Saccharate 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 Dextroamphetamine Saccharate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dextroamphetamine Saccharate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dextroamphetamine Saccharate suppliers with NDC on PharmaCompass.
Dextroamphetamine Saccharate 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 Dextroamphetamine Saccharate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Dextroamphetamine Saccharate GMP manufacturer or Dextroamphetamine Saccharate GMP API supplier for your needs.
A Dextroamphetamine Saccharate CoA (Certificate of Analysis) is a formal document that attests to Dextroamphetamine Saccharate's compliance with Dextroamphetamine Saccharate specifications and serves as a tool for batch-level quality control.
Dextroamphetamine Saccharate CoA mostly includes findings from lab analyses of a specific batch. For each Dextroamphetamine Saccharate 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.
Dextroamphetamine Saccharate may be tested according to a variety of international standards, such as European Pharmacopoeia (Dextroamphetamine Saccharate EP), Dextroamphetamine Saccharate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dextroamphetamine Saccharate USP).
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