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JDMF
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KDMF
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VMF
DRUG PRODUCT COMPOSITIONS0
FDF
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Data Compilation #PharmaFlow
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USDMF
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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 10M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 10MG
USFDA APPLICATION NUMBER - 17078
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 15M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 15MG
USFDA APPLICATION NUMBER - 17078
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 5MG
USFDA APPLICATION NUMBER - 17078
DOSAGE - SUSPENSION, EXTENDED RELEASE;ORAL - ...DOSAGE - SUSPENSION, EXTENDED RELEASE;ORAL - EQ 1.25MG BASE/ML
USFDA APPLICATION NUMBER - 204325
DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 12.5MG BASE
USFDA APPLICATION NUMBER - 204326
DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 15.7MG BASE
USFDA APPLICATION NUMBER - 204326
DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 18.8MG BASE
USFDA APPLICATION NUMBER - 204326
DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 3.1MG BASE
USFDA APPLICATION NUMBER - 204326
DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 6.3MG BASE
USFDA APPLICATION NUMBER - 204326
DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 9.4MG BASE
USFDA APPLICATION NUMBER - 204326
DOSAGE - SUSPENSION, EXTENDED RELEASE;ORAL - ...DOSAGE - SUSPENSION, EXTENDED RELEASE;ORAL - 2MG/ML;EQ 0.5MG BASE/ML
USFDA APPLICATION NUMBER - 208147
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12MG;EQ 3MG BASE
USFDA APPLICATION NUMBER - 210526
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 16MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 16MG;EQ 4MG BASE
USFDA APPLICATION NUMBER - 210526
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 4MG;...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 4MG;EQ 1MG BASE
USFDA APPLICATION NUMBER - 210526
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 8MG;...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 8MG;EQ 2MG BASE
USFDA APPLICATION NUMBER - 210526
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
54
PharmaCompass offers a list of Amphetamine Sulfate 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 Amphetamine Sulfate manufacturer or Amphetamine Sulfate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Amphetamine Sulfate manufacturer or Amphetamine Sulfate supplier.
PharmaCompass also assists you with knowing the Amphetamine Sulfate API Price utilized in the formulation of products. Amphetamine Sulfate API Price is not always fixed or binding as the Amphetamine Sulfate Price is obtained through a variety of data sources. The Amphetamine Sulfate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Psychoton manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Psychoton, including repackagers and relabelers. The FDA regulates Psychoton manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Psychoton 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 Psychoton manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Psychoton supplier is an individual or a company that provides Psychoton active pharmaceutical ingredient (API) or Psychoton finished formulations upon request. The Psychoton suppliers may include Psychoton API manufacturers, exporters, distributors and traders.
click here to find a list of Psychoton suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Psychoton DMF (Drug Master File) is a document detailing the whole manufacturing process of Psychoton active pharmaceutical ingredient (API) in detail. Different forms of Psychoton DMFs exist exist since differing nations have different regulations, such as Psychoton USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Psychoton DMF submitted to regulatory agencies in the US is known as a USDMF. Psychoton USDMF includes data on Psychoton's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Psychoton USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Psychoton suppliers with USDMF on PharmaCompass.
A Psychoton CEP of the European Pharmacopoeia monograph is often referred to as a Psychoton Certificate of Suitability (COS). The purpose of a Psychoton CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Psychoton EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Psychoton to their clients by showing that a Psychoton CEP has been issued for it. The manufacturer submits a Psychoton CEP (COS) as part of the market authorization procedure, and it takes on the role of a Psychoton CEP holder for the record. Additionally, the data presented in the Psychoton CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Psychoton DMF.
A Psychoton CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Psychoton CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Psychoton suppliers with CEP (COS) 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 Psychoton as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Psychoton 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 Psychoton 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 Psychoton and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Psychoton NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Psychoton suppliers with NDC on PharmaCompass.
Psychoton 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 Psychoton 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 Psychoton GMP manufacturer or Psychoton GMP API supplier for your needs.
A Psychoton CoA (Certificate of Analysis) is a formal document that attests to Psychoton's compliance with Psychoton specifications and serves as a tool for batch-level quality control.
Psychoton CoA mostly includes findings from lab analyses of a specific batch. For each Psychoton 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.
Psychoton may be tested according to a variety of international standards, such as European Pharmacopoeia (Psychoton EP), Psychoton JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Psychoton USP).
