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JDMF
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API SUPPLIERS
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USDMF
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Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
About the Company : Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expe...
Veranova: A CDMO that manages complexity with confidence.
About the Company : Veranova is a global leader in developing and manufacturing specialist and complex APIs for pharma and biotech customers, with over 50 years of experience supporting the healthcare...
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
About the Company : Malladi Drugs & Pharmaceuticals Ltd, founded in 1980 by Mr. M L N Sastry, is a leader in manufacturing ephedrine and pseudoephedrine salts. It is now the top API manufacturer in th...
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
About the Company : Supriya Lifescience Limited, established in 1987 and headquartered in Mumbai, is a globally recognized, technology-driven manufacturer of APIs, CDMO, and formulations. Its faciliti...
Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.
About the Company : Siegfried is a global Contract Development and Manufacturing Organization providing integrated services for pharmaceutical ingredients & finished dosage forms. With 13 production s...
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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
36
PharmaCompass offers a list of Amphetamine Sulfate 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 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.
A D-Amphetamine Sulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of D-Amphetamine Sulfate, including repackagers and relabelers. The FDA regulates D-Amphetamine Sulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. D-Amphetamine Sulfate 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 D-Amphetamine Sulfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A D-Amphetamine Sulfate supplier is an individual or a company that provides D-Amphetamine Sulfate active pharmaceutical ingredient (API) or D-Amphetamine Sulfate finished formulations upon request. The D-Amphetamine Sulfate suppliers may include D-Amphetamine Sulfate API manufacturers, exporters, distributors and traders.
click here to find a list of D-Amphetamine Sulfate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A D-Amphetamine Sulfate DMF (Drug Master File) is a document detailing the whole manufacturing process of D-Amphetamine Sulfate active pharmaceutical ingredient (API) in detail. Different forms of D-Amphetamine Sulfate DMFs exist exist since differing nations have different regulations, such as D-Amphetamine Sulfate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A D-Amphetamine Sulfate DMF submitted to regulatory agencies in the US is known as a USDMF. D-Amphetamine Sulfate USDMF includes data on D-Amphetamine Sulfate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The D-Amphetamine Sulfate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of D-Amphetamine Sulfate suppliers with USDMF on PharmaCompass.
A D-Amphetamine Sulfate CEP of the European Pharmacopoeia monograph is often referred to as a D-Amphetamine Sulfate Certificate of Suitability (COS). The purpose of a D-Amphetamine Sulfate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of D-Amphetamine Sulfate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of D-Amphetamine Sulfate to their clients by showing that a D-Amphetamine Sulfate CEP has been issued for it. The manufacturer submits a D-Amphetamine Sulfate CEP (COS) as part of the market authorization procedure, and it takes on the role of a D-Amphetamine Sulfate CEP holder for the record. Additionally, the data presented in the D-Amphetamine Sulfate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the D-Amphetamine Sulfate DMF.
A D-Amphetamine Sulfate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. D-Amphetamine Sulfate 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 D-Amphetamine Sulfate 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 D-Amphetamine Sulfate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for D-Amphetamine Sulfate 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 D-Amphetamine Sulfate 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 D-Amphetamine Sulfate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a D-Amphetamine Sulfate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of D-Amphetamine Sulfate suppliers with NDC on PharmaCompass.
D-Amphetamine Sulfate 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 D-Amphetamine Sulfate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right D-Amphetamine Sulfate GMP manufacturer or D-Amphetamine Sulfate GMP API supplier for your needs.
A D-Amphetamine Sulfate CoA (Certificate of Analysis) is a formal document that attests to D-Amphetamine Sulfate's compliance with D-Amphetamine Sulfate specifications and serves as a tool for batch-level quality control.
D-Amphetamine Sulfate CoA mostly includes findings from lab analyses of a specific batch. For each D-Amphetamine Sulfate 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.
D-Amphetamine Sulfate may be tested according to a variety of international standards, such as European Pharmacopoeia (D-Amphetamine Sulfate EP), D-Amphetamine Sulfate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (D-Amphetamine Sulfate USP).
