Synopsis
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JDMF
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EU WC
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KDMF
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VMF
DRUG PRODUCT COMPOSITIONS0
FDF
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
Curia- A partner for the pharma and biotech industries to improve patient outcomes & quality of life.
Veranova: A CDMO that manages complexity with confidence.
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.
Curia- A partner for the pharma and biotech industries to improve patient outcomes & quality of life.
Veranova: A CDMO that manages complexity with confidence.
Veranova: A CDMO that manages complexity with confidence.
Veranova: A CDMO that manages complexity with confidence.
Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.
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USDMF
Curia- A partner for the pharma and biotech industries to improve patient outcomes & quality of life.
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-03
Pay. Date : 2013-11-21
DMF Number : 16019
Submission : 2002-06-21
Status :
Type : II
Curia- A partner for the pharma and biotech industries to improve patient outcomes & quality of life.
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-03
Pay. Date : 2013-11-21
DMF Number : 16021
Submission : 2002-06-21
Status :
Type : II
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14783
Submission : 2000-03-17
Status :
Type : II
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-10
Pay. Date : 2013-04-03
DMF Number : 24048
Submission : 2010-07-08
Status :
Type : II
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-10
Pay. Date : 2013-04-03
DMF Number : 23583
Submission : 2010-03-04
Status :
Type : II
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15089
Submission : 2000-10-13
Status :
Type : II
Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-22
Pay. Date : 2023-11-03
DMF Number : 38836
Submission : 2023-10-20
Status :
Type : II
Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2016-05-24
Pay. Date : 2015-08-27
DMF Number : 29604
Submission : 2016-02-25
Status :
Type : II
Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2016-08-04
Pay. Date : 2015-08-27
DMF Number : 29601
Submission : 2016-02-25
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
Curia- A partner for the pharma and biotech industries to improve patient outcomes & quality of life.
About the Company : Curia is a global contract research, development and manufacturing organization (CDMO), offering products and services across the drug development spectrum to help our partners tur...
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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API Imports and Exports
Drugs in Development
Lead Product(s) : Amphetamine Sulfate,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Granules India Receives USFDA Tentative Nod for Generic ADHD Tablets
Details : Amphetamine Sulfate, a controlled substance targeting Norepinephrine and Dopamine transporters, shows promise in treating Attention Deficit Hyperactivity Disorder (ADHD).
Product Name : Dyanavel-Generic
Product Type : Controlled Substance
Upfront Cash : Inapplicable
January 08, 2026
Lead Product(s) : Amphetamine Sulfate,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Granules Pharma Gets USFDA Tentative Approval for Amphetamine ER ODT ANDA
Details : Amphetamine Sulfate, a small molecule product targeting Norepinephrine and Dopamine transporters, shows promise in treating Attention Deficit Hyperactivity Disorder.
Product Name : Adzenys XR-ODT-Generic
Product Type : Controlled Substance
Upfront Cash : Inapplicable
December 22, 2025
Lead Product(s) : Amphetamine Sulfate,Amphetamine Aspartate,Dextroamphetamine Saccharate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Granules Pharmaceuticals Inc., Receives ANDA Approval for Amphetamine Mixed Salts ER Capsules
Details : Dextroamphetamine Sulfate is a non-catecholamine sympathomimetic amines with CNS stimulant activity. It is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extr...
Product Name : Amphetamine-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 24, 2023
Lead Product(s) : Dextroamphetamine Saccharate,Amphetamine Aspartate,Amphetamine Sulfate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Granules Pharmaceuticals Receives ANDA Approval for Amphetamine Mixed Salts (IR Tablets)
Details : FDA approved generic of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, for Attention Deficit Hyperactivity Disorder and Narcolepsy.
Product Name : Adderall-Generic
Product Type : Controlled Substance
Upfront Cash : Inapplicable
December 30, 2021
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
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, founded in 1980 by Mr. M L N Sastry, is a leader in manufacturing ephedrine and pseudoephedrine salts. It is now the top AP...
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, acquired by PMC International in 2017, is a CDMO manufacturing cGMP intermediates, APIs, and functional excipients for global pharmaceutical and pe...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Aspen Pharmacare Australia Pty Ltd
Dosage Form :
Dosage Strength :
Packaging : 100
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]South Africa
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Synergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.
Regulatory Info :
Registration Country : India
Brand Name : Dextroamphetamine Sulf...
Dosage Form : Extended-Release Capsu...
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Synergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.
Regulatory Info :
Registration Country : India
Brand Name : Dextroamphetamine Sulf...
Dosage Form : Extended-Release Capsu...
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Synergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.
Regulatory Info :
Registration Country : India
Brand Name : Dextroamphetamine Sulf...
Dosage Form : Extended-Release Capsu...
Dosage Strength : 15MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Synergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.
Regulatory Info :
Registration Country : India
Brand Name : Dextroamphetamine Sulf...
Dosage Form : Tablet
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info :
Registration Country : India
Brand Name : Amphetamine Sulphate
Dosage Form : Immediate Release Tabl...
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info :
Registration Country : India
Brand Name : Mixed Amphetamines
Dosage Form : Extended Release Capsu...
Dosage Strength : 15MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info :
Registration Country : India
Brand Name : Mixed Amphetamines
Dosage Form : Extended Release Capsu...
Dosage Strength : 25MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info :
Registration Country : India
Brand Name : Mixed Amphetamines
Dosage Form : Extended Release Capsu...
Dosage Strength : 30MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info :
Registration Country : India
Brand Name : Mixed Amphetamines
Dosage Form : Immediate Release Tabl...
Dosage Strength : 7.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info :
Registration Country : India
Brand Name : Mixed Amphetamines
Dosage Form : Immediate Release Tabl...
Dosage Strength : 12.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
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 - 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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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Dosage Form : Cream / Lotion / Ointment
Grade : Topical, Parenteral
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Others
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
CAS Number : 22148-75-0
Quantity Per Vial :
Sale Unit :
Price :
Details : N-formylamphetamine
Monograph : 51634-2040
Storage :
Code/Batch No :
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
CAS Number : 60-13-9
Quantity Per Vial :
Sale Unit :
Price :
Details : USP Impurity
Monograph : 51634-2024
Storage :
Code/Batch No :
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
Dextroamphetamine Sulfate (CII)
CAS Number : 51-63-8
Quantity Per Vial :
Sale Unit :
Price :
Details : USP Impurity
Monograph : 51634-2022
Storage :
Code/Batch No :
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
Dextroamphetamine Sulfate, < 98% EE (CII)
CAS Number : 51-63-8
Quantity Per Vial :
Sale Unit :
Price :
Details :
Monograph : 51634-2022
Storage :
Code/Batch No :
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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 1-Phenyl-2-aminopropane sulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1-Phenyl-2-aminopropane sulfate, including repackagers and relabelers. The FDA regulates 1-Phenyl-2-aminopropane sulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1-Phenyl-2-aminopropane 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 1-Phenyl-2-aminopropane sulfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 1-Phenyl-2-aminopropane sulfate supplier is an individual or a company that provides 1-Phenyl-2-aminopropane sulfate active pharmaceutical ingredient (API) or 1-Phenyl-2-aminopropane sulfate finished formulations upon request. The 1-Phenyl-2-aminopropane sulfate suppliers may include 1-Phenyl-2-aminopropane sulfate API manufacturers, exporters, distributors and traders.
click here to find a list of 1-Phenyl-2-aminopropane sulfate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 1-Phenyl-2-aminopropane sulfate DMF (Drug Master File) is a document detailing the whole manufacturing process of 1-Phenyl-2-aminopropane sulfate active pharmaceutical ingredient (API) in detail. Different forms of 1-Phenyl-2-aminopropane sulfate DMFs exist exist since differing nations have different regulations, such as 1-Phenyl-2-aminopropane sulfate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 1-Phenyl-2-aminopropane sulfate DMF submitted to regulatory agencies in the US is known as a USDMF. 1-Phenyl-2-aminopropane sulfate USDMF includes data on 1-Phenyl-2-aminopropane sulfate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 1-Phenyl-2-aminopropane sulfate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 1-Phenyl-2-aminopropane sulfate suppliers with USDMF on PharmaCompass.
A 1-Phenyl-2-aminopropane sulfate CEP of the European Pharmacopoeia monograph is often referred to as a 1-Phenyl-2-aminopropane sulfate Certificate of Suitability (COS). The purpose of a 1-Phenyl-2-aminopropane sulfate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 1-Phenyl-2-aminopropane sulfate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 1-Phenyl-2-aminopropane sulfate to their clients by showing that a 1-Phenyl-2-aminopropane sulfate CEP has been issued for it. The manufacturer submits a 1-Phenyl-2-aminopropane sulfate CEP (COS) as part of the market authorization procedure, and it takes on the role of a 1-Phenyl-2-aminopropane sulfate CEP holder for the record. Additionally, the data presented in the 1-Phenyl-2-aminopropane sulfate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 1-Phenyl-2-aminopropane sulfate DMF.
A 1-Phenyl-2-aminopropane sulfate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 1-Phenyl-2-aminopropane 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 1-Phenyl-2-aminopropane 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 1-Phenyl-2-aminopropane sulfate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 1-Phenyl-2-aminopropane 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 1-Phenyl-2-aminopropane 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 1-Phenyl-2-aminopropane sulfate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 1-Phenyl-2-aminopropane sulfate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of 1-Phenyl-2-aminopropane sulfate suppliers with NDC on PharmaCompass.
1-Phenyl-2-aminopropane 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 1-Phenyl-2-aminopropane sulfate 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 1-Phenyl-2-aminopropane sulfate GMP manufacturer or 1-Phenyl-2-aminopropane sulfate GMP API supplier for your needs.
A 1-Phenyl-2-aminopropane sulfate CoA (Certificate of Analysis) is a formal document that attests to 1-Phenyl-2-aminopropane sulfate's compliance with 1-Phenyl-2-aminopropane sulfate specifications and serves as a tool for batch-level quality control.
1-Phenyl-2-aminopropane sulfate CoA mostly includes findings from lab analyses of a specific batch. For each 1-Phenyl-2-aminopropane 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.
1-Phenyl-2-aminopropane sulfate may be tested according to a variety of international standards, such as European Pharmacopoeia (1-Phenyl-2-aminopropane sulfate EP), 1-Phenyl-2-aminopropane sulfate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (1-Phenyl-2-aminopropane sulfate USP).
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