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    Chemistry

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    Also known as: Dl-amphetamine sulfate, Amphetamine sulphate, Phenaminum, 60-13-9, Amphamine sulfate, Amphetamini sulfas
    Molecular Formula
    C18H28N2O4S
    Molecular Weight
    368.5  g/mol
    InChI Key
    PYHRZPFZZDCOPH-UHFFFAOYSA-N
    FDA UNII
    6DPV8NK46S
    Amphetamine
    Amphetamine Sulfate is the sulfate salt form of amphetamine, a synthetic substance related to natural sympathomimetic amines. Amphetamine appears to exert its central nervous system (CNS) and peripheral effects indirectly by inducing the release of biogenic amines from their storage sites in nerve terminals. This agent is a commonly abused psychostimulant drug, which may be snorted, taken orally, smoked, or injected. Amphetamine induces psychologic dependence which is manifested by elevated mood, increased wakefulness, concentration, physical performance and a feeling of well-being. With sustained use, the effects of tachycardia and enhanced alertness diminish while psychotoxic effects such as hallucinations and delusions may occur. (NCI04)
    1 2D Structure

    Amphetamine

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    1-phenylpropan-2-amine;sulfuric acid
    2.1.2 InChI
    InChI=1S/2C9H13N.H2O4S/c2*1-8(10)7-9-5-3-2-4-6-9;1-5(2,3)4/h2*2-6,8H,7,10H2,1H3;(H2,1,2,3,4)
    2.1.3 InChI Key
    PYHRZPFZZDCOPH-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC(CC1=CC=CC=C1)N.CC(CC1=CC=CC=C1)N.OS(=O)(=O)O
    2.2 Other Identifiers
    2.2.1 UNII
    6DPV8NK46S
    2.3 Synonyms
    2.3.1 Depositor-Supplied Synonyms

    1. Dl-amphetamine Sulfate

    2. Amphetamine Sulphate

    3. Phenaminum

    4. 60-13-9

    5. Amphamine Sulfate

    6. Amphetamini Sulfas

    7. Dl-phenamine Sulfate

    8. Dl-amphetamine Sulphate

    9. Amphetaminium Sulfuricum

    10. Desoxynorephedrine Sulfate

    11. (+-)-amphetamine Sulfate

    12. Dl-amphetamine Hydrogen Sulfate

    13. (+-)-phenisopropylamine Sulfate

    14. Amfetamine Sulfate

    15. Amphetamine Sulfate [usp]

    16. Dl-1-phenyl-2-aminopropane Sulfate

    17. (+-)-2-amino-1-phenylpropane Sulfate

    18. (+-)-alpha-methylphenethylamine Sulfate (2:1)

    19. 6dpv8nk46s

    20. 1-phenylpropan-2-amine Sulfate (2:1)

    21. Amphetamine Sulfate (usp)

    22. Fenopromin Sulfate

    23. Penamine (van)

    24. Ccris 3644

    25. 1-phenyl-2-aminopropane Sulfate

    26. Cerm 1767

    27. Razemisches Phenylaminopropansulfat

    28. Dl-alpha-methylphenethylamine Sulfate

    29. Einecs 200-457-8

    30. Unii-6dpv8nk46s

    31. Nsc 170999

    32. Dl-amphetamine Sulfate Salt

    33. Benzadrine

    34. Alpha-methylphenethylamine Sulfate, (+-)-

    35. Benzedrine (tn)

    36. Evekeo (tn)

    37. Evekeo Odt

    38. Rac-amphetamine Sulphate

    39. D-amphetamine Sulfate Salt

    40. Schembl41204

    41. Amphetamine Sulfate [mi]

    42. Dtxsid4020082

    43. Phenethylamine, Alpha-methyl-, Sulfate (2:1), (+-)-

    44. Chebi:51063

    45. Amfetamine Sulfate [mart.]

    46. Amphetamine Sulfate [vandf]

    47. Amfetamine Sulfate [who-dd]

    48. Bis{1-phenylpropan-2-amine} Sulfate

    49. Amfetamine Sulfate [ep Impurity]

    50. Amfetamine Sulfate [ep Monograph]

    51. Amphetamine Sulfate [orange Book]

    52. .beta.-phenylisopyropylaminesulfate

    53. Benzeneethanamine, Alpha-methyl-, Sulfate

    54. Amphetamine Sulfate [usp Monograph]

    55. Amfetamine Sulfate [incb:green List]

    56. Delcobese Component Amphetamine Sulfate

    57. D02074

    58. (+/-)-2-amino-1-phenylpropane Sulfate

    59. (+/-)-2-amino-1-phenylpropane Sulphate

    60. Amphetamine Sulfate Component Of Delcobese

    61. Q21270844

    62. (+/-)-.alpha.-methylphenethylamine Sulfate (2:1)

    63. (+/-)-.alpha.-methylphenethylamine Sulphate (2:1)

    64. Benzeneethanamine, .alpha.-methyl-, Sulfate (2:1), (+/-)-

    65. Benzeneethanamine, .alpha.-methyl-, Sulphate (2:1), (+/-)-

    66. Dl-amphetamine Sulfate Salt Solution, Drug Standard, 1.0 Mg/ml In Methanol

    67. 2-(tetrahydro-furan-2-yl)-n-(3-trifluoromethyl-phenyl)-succinamicacid

    68. 156-31-0

    2.3.2 Other Synonyms

    1. Amfetamine

    2. Mydrial

    3. Desoxynorephedrine

    4. L Amphetamine

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 368.5 g/mol
    Molecular Formula C18H28N2O4S
    Hydrogen Bond Donor Count4
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count4
    Exact Mass368.17697855 g/mol
    Monoisotopic Mass368.17697855 g/mol
    Topological Polar Surface Area135 Ų
    Heavy Atom Count25
    Formal Charge0
    Complexity166
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count2
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count3

    API Reference Price

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LIMITED","supplierCountry":"UNITED STATES","foreign_port":"NA","customer":"ALFRED E TIEFENBACHER GMBH","customerCountry":"INDIA","quantity":"0.05","actualQuantity":"0.05","unit":"KGS","unitRateFc":"40000","totalValueFC":"2043.9","currency":"USD","unitRateINR":"3064087.6","date":"14-Feb-2022","totalValueINR":"153204.38","totalValueInUsd":"2043.9","indian_port":"HYDERABAD AIR","hs_no":"29349990","bill_no":"7478091","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"SURVEY NO.42, GADDAPOTHARAM,KAZIPA LLY IND AREA, SANGAREDDY DIST"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1644777000,"product":"BP-754 D--LYSINE-D-AMPHETAMINE DIMESYLATE R.S","address":"SURVEY NO.42, GADDAPOTHARAM,KAZIPA LLY IND AREA, SANGAREDDY DIST","city":"GADDAPOTHARAM HYD,TELANGANA","supplier":"MALLNCKRODT CHEMICAL LIMITED","supplierCountry":"UNITED STATES","foreign_port":"NA","customer":"ALFRED E TIEFENBACHER GMBH","customerCountry":"INDIA","quantity":"0.05","actualQuantity":"0.05","unit":"KGS","unitRateFc":"40000","totalValueFC":"2043.9","currency":"USD","unitRateINR":"3064087.6","date":"14-Feb-2022","totalValueINR":"153204.38","totalValueInUsd":"2043.9","indian_port":"HYDERABAD AIR","hs_no":"29349990","bill_no":"7478091","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"SURVEY NO.42, GADDAPOTHARAM,KAZIPA LLY IND AREA, SANGAREDDY DIST"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1680719400,"product":"AMPHETAMINE SULFATE (ITEM 494206) AS PER INV","address":"SURVEY NO.42, GADDAPOTHARAM,KAZIPA LLY IND AREA, SANGAREDDY DIST","city":"GADDAPOTHARAM HYD,TELANGANA","supplier":"MALLNCKRODT CHEMICAL LIMITED","supplierCountry":"UNITED STATES","foreign_port":"NA","customer":"ALFRED E TIEFENBACHER GMBH","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"2400","totalValueFC":"2478.7","currency":"USD","unitRateINR":"203139.9","date":"06-Apr-2023","totalValueINR":"203139.9","totalValueInUsd":"2478.7","indian_port":"HYDERABAD AIR","hs_no":"29349990","bill_no":"5397219","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"SURVEY NO.42, GADDAPOTHARAM,KAZIPA LLY IND AREA, SANGAREDDY DIST"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1680719400,"product":"DEXTROAMPHETAMINE SACCHARATE (ITEM 290126) AS PER INV","address":"SURVEY NO.42, GADDAPOTHARAM,KAZIPA LLY IND AREA, SANGAREDDY DIST","city":"GADDAPOTHARAM HYD,TELANGANA","supplier":"MALLNCKRODT CHEMICAL LIMITED","supplierCountry":"UNITED STATES","foreign_port":"NA","customer":"ALFRED E TIEFENBACHER GMBH","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"2400","totalValueFC":"2478.7","currency":"USD","unitRateINR":"203139.9","date":"06-Apr-2023","totalValueINR":"203139.9","totalValueInUsd":"2478.7","indian_port":"HYDERABAD AIR","hs_no":"29349990","bill_no":"5397219","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"SURVEY NO.42, GADDAPOTHARAM,KAZIPA LLY IND AREA, SANGAREDDY DIST"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1680719400,"product":"DEXTROAMPHETAMINE SULFATE (ITEM 195026) AS PER INV","address":"SURVEY NO.42, GADDAPOTHARAM,KAZIPA LLY IND AREA, SANGAREDDY DIST","city":"GADDAPOTHARAM HYD,TELANGANA","supplier":"MALLNCKRODT CHEMICAL LIMITED","supplierCountry":"UNITED STATES","foreign_port":"NA","customer":"ALFRED E TIEFENBACHER GMBH","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"2400","totalValueFC":"2478.7","currency":"USD","unitRateINR":"203139.9","date":"06-Apr-2023","totalValueINR":"203139.9","totalValueInUsd":"2478.7","indian_port":"HYDERABAD AIR","hs_no":"29349990","bill_no":"5397219","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"SURVEY NO.42, GADDAPOTHARAM,KAZIPA LLY IND AREA, SANGAREDDY DIST"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1699900200,"product":"DEXAMPHETAMINE SULPHATE (IMPORT PERMIT NO.P\/IMP-10650\/2023 DT.27\/10\/2023)","address":"781, INDUSTRIAL AREA,","city":"CHANDIGARH.","supplier":"CHR. OLESEN GROUP","supplierCountry":"DENMARK","foreign_port":"COPENHAGEN","customer":"IND SWIFT LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"12.00","actualQuantity":"12","unit":"KGS","unitRateFc":"4500","totalValueFC":"58266.5","currency":"EUR","unitRateINR":"404325","date":"14-Nov-2023","totalValueINR":"4851900","totalValueInUsd":"58266.5","indian_port":"Delhi Air","hs_no":"29214600","bill_no":"8758267","productDescription":"API","marketType":"REGULATED MARKET","country":"DENMARK","selfForZScoreResived":"Pharma Grade","supplierPort":"COPENHAGEN","supplierAddress":"KANALHOLMEN 8-12 DK-2650 HVIDOVRE DENMARK, , DENMARKSDNF DENMARK","customerAddress":"781, INDUSTRIAL AREA,"}]
    26-Aug-2021
    27-Mar-2025
    KGS
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    Average Price (USD/KGS)

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    API Imports and Exports

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 10M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 10MG

    USFDA APPLICATION NUMBER - 17078

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 15M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 15MG

    USFDA APPLICATION NUMBER - 17078

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 5MG

    USFDA APPLICATION NUMBER - 17078

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    DOSAGE - SUSPENSION, EXTENDED RELEASE;ORAL - ...DOSAGE - SUSPENSION, EXTENDED RELEASE;ORAL - EQ 1.25MG BASE/ML

    USFDA APPLICATION NUMBER - 204325

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    DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 12.5MG BASE

    USFDA APPLICATION NUMBER - 204326

    read-more

    DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 15.7MG BASE

    USFDA APPLICATION NUMBER - 204326

    read-more

    DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 18.8MG BASE

    USFDA APPLICATION NUMBER - 204326

    read-more

    DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 3.1MG BASE

    USFDA APPLICATION NUMBER - 204326

    read-more

    DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 6.3MG BASE

    USFDA APPLICATION NUMBER - 204326

    read-more

    DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 9.4MG BASE

    USFDA APPLICATION NUMBER - 204326

    read-more

    DOSAGE - SUSPENSION, EXTENDED RELEASE;ORAL - ...DOSAGE - SUSPENSION, EXTENDED RELEASE;ORAL - 2MG/ML;EQ 0.5MG BASE/ML

    USFDA APPLICATION NUMBER - 208147

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12MG;EQ 3MG BASE

    USFDA APPLICATION NUMBER - 210526

    read-more

    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 16MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 16MG;EQ 4MG BASE

    USFDA APPLICATION NUMBER - 210526

    read-more

    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 4MG;...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 4MG;EQ 1MG BASE

    USFDA APPLICATION NUMBER - 210526

    read-more

    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 8MG;...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 8MG;EQ 2MG BASE

    USFDA APPLICATION NUMBER - 210526

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 1.2...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 1.25MG;1.25MG;1.25MG;1.25MG

    USFDA APPLICATION NUMBER - 21303

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    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 2.5...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 2.5MG;2.5MG;2.5MG;2.5MG

    USFDA APPLICATION NUMBER - 21303

    read-more

    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 3.7...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 3.75MG;3.75MG;3.75MG;3.75MG

    USFDA APPLICATION NUMBER - 21303

    read-more

    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 5MG...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 5MG;5MG;5MG;5MG

    USFDA APPLICATION NUMBER - 21303

    read-more

    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 6.2...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 6.25MG;6.25MG;6.25MG;6.25MG

    USFDA APPLICATION NUMBER - 21303

    read-more

    DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 7.5...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 7.5MG;7.5MG;7.5MG;7.5MG

    USFDA APPLICATION NUMBER - 21303

    read-more

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    ABOUT THIS PAGE

    Looking for 156-31-0 / Amphetamine API manufacturers, exporters & distributors?

    Amphetamine manufacturers, exporters & distributors 1

    81

    PharmaCompass offers a list of Amphetamine 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 manufacturer or Amphetamine supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Amphetamine manufacturer or Amphetamine supplier.

    PharmaCompass also assists you with knowing the Amphetamine API Price utilized in the formulation of products. Amphetamine API Price is not always fixed or binding as the Amphetamine Price is obtained through a variety of data sources. The Amphetamine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Amphetamine

    Synonyms

    Dl-amphetamine sulfate, Amphetamine sulphate, Phenaminum, 60-13-9, Amphamine sulfate, Amphetamini sulfas

    Cas Number

    156-31-0

    Unique Ingredient Identifier (UNII)

    6DPV8NK46S

    About Amphetamine

    Amphetamine Sulfate is the sulfate salt form of amphetamine, a synthetic substance related to natural sympathomimetic amines. Amphetamine appears to exert its central nervous system (CNS) and peripheral effects indirectly by inducing the release of biogenic amines from their storage sites in nerve terminals. This agent is a commonly abused psychostimulant drug, which may be snorted, taken orally, smoked, or injected. Amphetamine induces psychologic dependence which is manifested by elevated mood, increased wakefulness, concentration, physical performance and a feeling of well-being. With sustained use, the effects of tachycardia and enhanced alertness diminish while psychotoxic effects such as hallucinations and delusions may occur. (NCI04)

    ADZENYS XR-ODT Manufacturers

    A ADZENYS XR-ODT manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ADZENYS XR-ODT, including repackagers and relabelers. The FDA regulates ADZENYS XR-ODT manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ADZENYS XR-ODT 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 ADZENYS XR-ODT manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    ADZENYS XR-ODT Suppliers

    A ADZENYS XR-ODT supplier is an individual or a company that provides ADZENYS XR-ODT active pharmaceutical ingredient (API) or ADZENYS XR-ODT finished formulations upon request. The ADZENYS XR-ODT suppliers may include ADZENYS XR-ODT API manufacturers, exporters, distributors and traders.

    click here to find a list of ADZENYS XR-ODT suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    ADZENYS XR-ODT USDMF

    A ADZENYS XR-ODT DMF (Drug Master File) is a document detailing the whole manufacturing process of ADZENYS XR-ODT active pharmaceutical ingredient (API) in detail. Different forms of ADZENYS XR-ODT DMFs exist exist since differing nations have different regulations, such as ADZENYS XR-ODT USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A ADZENYS XR-ODT DMF submitted to regulatory agencies in the US is known as a USDMF. ADZENYS XR-ODT USDMF includes data on ADZENYS XR-ODT's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ADZENYS XR-ODT USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of ADZENYS XR-ODT suppliers with USDMF on PharmaCompass.

    ADZENYS XR-ODT CEP

    A ADZENYS XR-ODT CEP of the European Pharmacopoeia monograph is often referred to as a ADZENYS XR-ODT Certificate of Suitability (COS). The purpose of a ADZENYS XR-ODT CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of ADZENYS XR-ODT EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of ADZENYS XR-ODT to their clients by showing that a ADZENYS XR-ODT CEP has been issued for it. The manufacturer submits a ADZENYS XR-ODT CEP (COS) as part of the market authorization procedure, and it takes on the role of a ADZENYS XR-ODT CEP holder for the record. Additionally, the data presented in the ADZENYS XR-ODT CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the ADZENYS XR-ODT DMF.

    A ADZENYS XR-ODT CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. ADZENYS XR-ODT 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 ADZENYS XR-ODT suppliers with CEP (COS) on PharmaCompass.

    ADZENYS XR-ODT NDC

    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 ADZENYS XR-ODT as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for ADZENYS XR-ODT API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    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 ADZENYS XR-ODT 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.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain ADZENYS XR-ODT and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a ADZENYS XR-ODT NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of ADZENYS XR-ODT suppliers with NDC on PharmaCompass.

    ADZENYS XR-ODT GMP

    ADZENYS XR-ODT 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 ADZENYS XR-ODT 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 ADZENYS XR-ODT GMP manufacturer or ADZENYS XR-ODT GMP API supplier for your needs.

    ADZENYS XR-ODT CoA

    A ADZENYS XR-ODT CoA (Certificate of Analysis) is a formal document that attests to ADZENYS XR-ODT's compliance with ADZENYS XR-ODT specifications and serves as a tool for batch-level quality control.

    ADZENYS XR-ODT CoA mostly includes findings from lab analyses of a specific batch. For each ADZENYS XR-ODT 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.

    ADZENYS XR-ODT may be tested according to a variety of international standards, such as European Pharmacopoeia (ADZENYS XR-ODT EP), ADZENYS XR-ODT JP (Japanese Pharmacopeia) and the US Pharmacopoeia (ADZENYS XR-ODT USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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