Synopsis
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CEP/COS
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JDMF
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EU WC
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KDMF
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VMF
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FDF
0
Europe
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Canada
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Australia
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South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS0
EDQM
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USP
0
JP
0
Others
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
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USDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Coating Systems & Additives
Controlled & Modified Release
Direct Compression
Thickeners and Stabilizers
Lubricants & Glidants
Granulation
Taste Masking
Film Formers & Plasticizers
Co-Processed Excipients
Disintegrants & Superdisintegrants
Solubilizers
Empty Capsules
Chewable & Orodispersible Aids
Vegetarian Capsules
API Stability Enhancers
Coloring Agents
Emulsifying Agents
Parenteral
Rheology Modifiers
Surfactant & Foaming Agents
Topical
Digital Content
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ABOUT THIS PAGE
A Amphetamine Aspartate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amphetamine Aspartate, including repackagers and relabelers. The FDA regulates Amphetamine Aspartate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amphetamine Aspartate 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 Amphetamine Aspartate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amphetamine Aspartate supplier is an individual or a company that provides Amphetamine Aspartate active pharmaceutical ingredient (API) or Amphetamine Aspartate finished formulations upon request. The Amphetamine Aspartate suppliers may include Amphetamine Aspartate API manufacturers, exporters, distributors and traders.
click here to find a list of Amphetamine Aspartate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Amphetamine Aspartate DMF (Drug Master File) is a document detailing the whole manufacturing process of Amphetamine Aspartate active pharmaceutical ingredient (API) in detail. Different forms of Amphetamine Aspartate DMFs exist exist since differing nations have different regulations, such as Amphetamine Aspartate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amphetamine Aspartate DMF submitted to regulatory agencies in the US is known as a USDMF. Amphetamine Aspartate USDMF includes data on Amphetamine Aspartate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amphetamine Aspartate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Amphetamine Aspartate 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 Amphetamine Aspartate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Amphetamine Aspartate 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 Amphetamine Aspartate 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 Amphetamine Aspartate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Amphetamine Aspartate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Amphetamine Aspartate suppliers with NDC on PharmaCompass.
Amphetamine Aspartate 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 Amphetamine Aspartate 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 Amphetamine Aspartate GMP manufacturer or Amphetamine Aspartate GMP API supplier for your needs.
A Amphetamine Aspartate CoA (Certificate of Analysis) is a formal document that attests to Amphetamine Aspartate's compliance with Amphetamine Aspartate specifications and serves as a tool for batch-level quality control.
Amphetamine Aspartate CoA mostly includes findings from lab analyses of a specific batch. For each Amphetamine Aspartate 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.
Amphetamine Aspartate may be tested according to a variety of international standards, such as European Pharmacopoeia (Amphetamine Aspartate EP), Amphetamine Aspartate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Amphetamine Aspartate USP).
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