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JDMF
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VMF
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API SUPPLIERS
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USDMF
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Veranova: A CDMO that manages complexity with confidence.
About the Company : Veranova is a global leader in the development and manufacturing of specialist and complex APIs for pharma and biotech customers. We have over 50 years of experience navigating the...
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Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
dl-1-Chloro-1-phenyl-2-aminopropane Hydrochloride
CAS Number : 25394-33-6
End Use API : Amphetamine Sulfate
About The Company : Malladi Drugs & Pharmaceuticals Ltd was founded in 1980 by microbiologist Mr. M L N Sastry. Within a few years, Malladi established itself as a leader in manufa...
PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
CAS Number : 3182-95-4
End Use API : Amphetamine Sulfate
About The Company : PMC Isochem is a CDMO company acquired by PMC International in 2017. It manufactures cGMP intermediates, active pharmaceutical ingredients and functional excipi...
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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
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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 Amphetasul manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amphetasul, including repackagers and relabelers. The FDA regulates Amphetasul manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amphetasul 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 Amphetasul manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amphetasul supplier is an individual or a company that provides Amphetasul active pharmaceutical ingredient (API) or Amphetasul finished formulations upon request. The Amphetasul suppliers may include Amphetasul API manufacturers, exporters, distributors and traders.
click here to find a list of Amphetasul suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Amphetasul DMF (Drug Master File) is a document detailing the whole manufacturing process of Amphetasul active pharmaceutical ingredient (API) in detail. Different forms of Amphetasul DMFs exist exist since differing nations have different regulations, such as Amphetasul USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amphetasul DMF submitted to regulatory agencies in the US is known as a USDMF. Amphetasul USDMF includes data on Amphetasul's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amphetasul USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Amphetasul suppliers with USDMF on PharmaCompass.
A Amphetasul CEP of the European Pharmacopoeia monograph is often referred to as a Amphetasul Certificate of Suitability (COS). The purpose of a Amphetasul CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Amphetasul EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Amphetasul to their clients by showing that a Amphetasul CEP has been issued for it. The manufacturer submits a Amphetasul CEP (COS) as part of the market authorization procedure, and it takes on the role of a Amphetasul CEP holder for the record. Additionally, the data presented in the Amphetasul CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Amphetasul DMF.
A Amphetasul CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Amphetasul 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 Amphetasul 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 Amphetasul as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Amphetasul 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 Amphetasul 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 Amphetasul and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Amphetasul NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Amphetasul suppliers with NDC on PharmaCompass.
Amphetasul 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 Amphetasul 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 Amphetasul GMP manufacturer or Amphetasul GMP API supplier for your needs.
A Amphetasul CoA (Certificate of Analysis) is a formal document that attests to Amphetasul's compliance with Amphetasul specifications and serves as a tool for batch-level quality control.
Amphetasul CoA mostly includes findings from lab analyses of a specific batch. For each Amphetasul 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.
Amphetasul may be tested according to a variety of international standards, such as European Pharmacopoeia (Amphetasul EP), Amphetasul JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Amphetasul USP).
