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    Also known as: 113-92-8, Chlorphenamine maleate, Neorestamin, Synistamin, Piriton, Chlor-trimeton
    Molecular Formula
    C20H23ClN2O4
    Molecular Weight
    390.9  g/mol
    InChI Key
    DBAKFASWICGISY-BTJKTKAUSA-N
    FDA UNII
    V1Q0O9OJ9Z
    Chlorpheniramine Maleate
    A histamine H1 antagonist used in allergic reactions, hay fever, rhinitis, urticaria, and asthma. It has also been used in veterinary applications. One of the most widely used of the classical antihistaminics, it generally causes less drowsiness and sedation than PROMETHAZINE.
    1 2D Structure

    Chlorpheniramine Maleate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (Z)-but-2-enedioic acid;3-(4-chlorophenyl)-N,N-dimethyl-3-pyridin-2-ylpropan-1-amine
    2.1.2 InChI
    InChI=1S/C16H19ClN2.C4H4O4/c1-19(2)12-10-15(16-5-3-4-11-18-16)13-6-8-14(17)9-7-13;5-3(6)1-2-4(7)8/h3-9,11,15H,10,12H2,1-2H3;1-2H,(H,5,6)(H,7,8)/b;2-1-
    2.1.3 InChI Key
    DBAKFASWICGISY-BTJKTKAUSA-N
    2.1.4 Canonical SMILES
    CN(C)CCC(C1=CC=C(C=C1)Cl)C2=CC=CC=N2.C(=CC(=O)O)C(=O)O
    2.1.5 Isomeric SMILES
    CN(C)CCC(C1=CC=C(C=C1)Cl)C2=CC=CC=N2.C(=C\C(=O)O)\C(=O)O
    2.2 Other Identifiers
    2.2.1 UNII
    V1Q0O9OJ9Z
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Aller-chlor

    2. Antihistaminico Llorens

    3. Chlo-amine

    4. Chlor-100

    5. Chlor-trimeton

    6. Chlor-tripolon

    7. Chlorphenamine

    8. Chlorpheniramine

    9. Chlorpheniramine Tannate

    10. Chlorpro

    11. Chlorprophenpyridamine

    12. Chlorspan 12

    13. Chlortab-4

    14. Cloro-trimeton

    15. Efidac 24

    16. Kloromin

    17. Maleate, Chlorpheniramine

    18. Piriton

    19. Tannate, Chlorpheniramine

    20. Teldrin

    2.3.2 Depositor-Supplied Synonyms

    1. 113-92-8

    2. Chlorphenamine Maleate

    3. Neorestamin

    4. Synistamin

    5. Piriton

    6. Chlor-trimeton

    7. Antagonate

    8. Kloromin

    9. Chlorphenamine Hydrogen Maleate

    10. Histaspan

    11. Pyridamal

    12. Efidac

    13. Chlorpheniramine (maleate)

    14. Nci-c55265

    15. Polaronil

    16. Chlorphenamine Maleates

    17. V1q0o9oj9z

    18. Chlorpheniramine Maleate Salt

    19. Chlorprophenpyridamine Maleate

    20. Chloropheniramine Maleate

    21. Chebi:3645

    22. 3-(4-chlorophenyl)-n,n-dimethyl-3-(pyridin-2-yl)propan-1-amine Maleate

    23. Nsc-756684

    24. Chlortrimeton

    25. Allerclor

    26. Allergin

    27. Chlormene

    28. Ibioton

    29. Lorphen

    30. Alunex

    31. Dehist

    32. Piriex

    33. Chlor-tripolon

    34. C-meton

    35. (z)-but-2-enedioic Acid;3-(4-chlorophenyl)-n,n-dimethyl-3-pyridin-2-ylpropan-1-amine

    36. Histadur Dura-tabs

    37. Chlor-trimeton Od

    38. Pyridamal 100

    39. Pyridamal-100

    40. Polaronil [german]

    41. Carbinoxamide Maleate

    42. Chlor-trimeton Allergy

    43. Phenalin

    44. Chlor-trimeton Injection

    45. Histaspan-plus

    46. Histaspan-d

    47. Medique Chlorphen

    48. Dl-chlorpheniramine Maleate

    49. Ru-tuss Capsules

    50. Smr000466271

    51. Chloroprophenpyridamine Maleate

    52. Ccris 1418

    53. 3-(4-chlorophenyl)-n,n-dimethyl-3-pyridin-2-ylpropan-1-aminium (2z)-3-carboxyprop-2-enoate

    54. Chlor-trimeton 12 Hour

    55. Efidac 24 Chlorpheniramine Maleate

    56. Sr-01000075261

    57. M.p. Chlorcaps T.d.

    58. Einecs 204-037-5

    59. Mfcd00069225

    60. Chlorpheniramine Maleate Oros Tablets

    61. Unii-v1q0o9oj9z

    62. Nasohist

    63. Puermin

    64. Corfen

    65. Lohist

    66. Chlor-trimeton Repetabs, Syrup, And Tablets

    67. Sine Off

    68. Sildec Pe

    69. Alka-seltzer Plus

    70. Prestwick_57

    71. Chlorphenaminemaleate

    72. Chlorpheniramine Maleate [usp:jan]

    73. Teldrin (tn)

    74. (+/-)-chlorpheniramine Maleate Salt

    75. Chlorophenaminemaleate

    76. Zodryl Ac 25

    77. Zodryl Ac 30

    78. Zodryl Ac 40

    79. Zodryl Ac 50

    80. Zodryl Ac 60

    81. Zodryl Ac 80

    82. Chlor-trimeton (tn)

    83. 1-p-chlorophenyl-1-(2-pyridyl)-3-dimethylaminopropane Maleate

    84. Dl-2-(p-chloro-alpha-2-(dimethylamino)ethylbenzyl)pyridine Maleate

    85. 1-(n,n-dimethylamino)-3-(p-chlorophenyl-3-alpha-pyridyl)propane Maleate

    86. 1-(p-chlorphenyl)-1-(2-pyridyl)-3-dimethylaminopropan Maleat [german]

    87. 2-(p-chloro-alpha-(2-(dimethylamino)ethyl)benzyl)pyridine Maleate (1:1)

    88. Chembl1659

    89. (y)-chlorpheniramine Maleate

    90. Chlorphenamini Hydrogenomaleas

    91. Schembl33357

    92. (?)-chlorpheniramine Maleate

    93. Mls000758311

    94. Mls001148230

    95. Mls001424173

    96. (+/-)-chlorpheniramine Maleate

    97. Hms501n18

    98. Hy-b0286a

    99. (a+/-)-chlorpheniramine Maleate

    100. Amf0009

    101. 1-(p-chlorphenyl)-1-(2-pyridyl)-3-dimethylaminopropan Maleat

    102. Hms1568g16

    103. Hms2051l14

    104. Hms2093n19

    105. Hms2095g16

    106. Hms2230f21

    107. Hms2232b23

    108. Hms3260f04

    109. Hms3712g16

    110. Hms3884o10

    111. Pharmakon1600-01505530

    112. Tox21_500261

    113. Ac-267

    114. Chlorpheniramine Maleate [mi]

    115. Nsc759156

    116. S1816

    117. Chlorpheniramine Maleate (jp17/usp)

    118. Chlorpheniramine Maleate [jan]

    119. Akos015951220

    120. Chlorphenamine Maleate [mart.]

    121. Pyridine, 2-(p-chloro-alpha-(2-(dimethylamino)ethyl)benzyl)-, Maleate (1:1)

    122. Ccg-101036

    123. Ccg-220117

    124. Ccg-221565

    125. Chlorphenamine Maleate [who-dd]

    126. Lp00261

    127. Nc00286

    128. Nsc 756684

    129. 2-pyridinepropanamine, .gamma.-(4-chlorophenyl)-n,n-dimethyl-, (z)-2-butenedioate (1:1)

    130. 2-pyridinepropanamine, Gamma-(4-chlorophenyl)-n,n-dimethyl-, (z)-2-butenedioate (1:1)

    131. Chlorpheniramine Maleate [vandf]

    132. Chlorpheniramine Maleate [usp-rs]

    133. Ncgc00093720-01

    134. Ncgc00093720-02

    135. Ncgc00260946-01

    136. As-13167

    137. Smr000653461

    138. Chlorphenamine Maleate [ep Monograph]

    139. Eu-0100261

    140. Sw196372-4

    141. Chlorpheniramine Maleate [orange Book]

    142. C 3025

    143. C07780

    144. Chlorpheniramine Maleate [usp Monograph]

    145. Contac Component Chlorpheniramine Maleate

    146. D00665

    147. D70131

    148. Drize Component Chlorpheniramine Maleate

    149. Ornade Component Chlorpheniramine Maleate

    150. Chlorphenamine Hydrogen Maleate [who-ip]

    151. Demazin Component Chlorpheniramine Maleate

    152. Isoclor Component Chlorpheniramine Maleate

    153. ( Inverted Question Mark)-chlorpheniramine Maleate

    154. Chlorpheniramine Maleate Component Of Contac

    155. Chlorpheniramine Maleate Component Of Drize

    156. Chlorpheniramine Maleate Component Of Ornade

    157. Triaminic Component Chlorpheniramine Maleate

    158. Chlorphenamini Hydrogenomaleas [who-ip Latin]

    159. Chlorpheniramine Maleate 100 Microg/ml In Methanol

    160. Chlorpheniramine Maleate Component Of Demazin

    161. Chlorpheniramine Maleate Component Of Isoclor

    162. Sr-01000075261-1

    163. Sr-01000075261-9

    164. W-108612

    165. Chlorpheniramine Maleate Component Of Triaminic

    166. Q27106157

    167. F2173-0923

    168. Codimal-l.a. 12 Component Chlorpheniramine Maleate

    169. Advil Allergy Sinus Component Chlorpheniramine Maleate

    170. Chlorpheniramine Maleate Component Of Advil Allergy Sinus

    171. Chlorpheniramine Maleate Component Of Codimal-l.a. 12

    172. (+/-)-chlorpheniramine Maleate Salt >=99% (perchloric Acid Titration)

    173. (+/-)-chlorpheniramine Maleate Salt, >=99% (perchloric Acid Titration)

    174. [3-(4-chloro-phenyl)-3-pyridin-2-yl-propyl]-dimethyl-amine Maleate

    175. Chlorphenamine Maleate, European Pharmacopoeia (ep) Reference Standard

    176. 2-(p-chloro-.alpha.-(2-(dimethylamino)ethyl)benzyl)pyridine Maleate (1:1)

    177. 2-pyridinepropanamine, Gamma-(4-chlorophenyl)-n,n-dimethyl-, (2z)-2-butenedioate (1:1)

    178. Chlorphenamine Maleate (chlorpheniramine Maleate) 1.0 Mg/ml In Methanol (as Free Base)

    179. Chlorpheniramine Maleate, Pharmaceutical Secondary Standard; Certified Reference Material

    180. Chlorpheniramine Maleate, United States Pharmacopeia (usp) Reference Standard

    181. Chlorpheniramine Maleate Salt Solution, 1.0 Mg/ml In Methanol (as Free Base), Ampule Of 1 Ml, Certified Reference Material

    2.3.3 Other Synonyms

    1. Chlorpheniaramine Maleate

    2. Chloropheniramine Maleate

    3. Chlorphenamine Maleate

    2.4 Create Date
    2005-03-27
    3 Chemical and Physical Properties
    Molecular Weight 390.9 g/mol
    Molecular Formula C20H23ClN2O4
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count7
    Exact Mass390.1346349 g/mol
    Monoisotopic Mass390.1346349 g/mol
    Topological Polar Surface Area90.7 Ų
    Heavy Atom Count27
    Formal Charge0
    Complexity368
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count1
    Defined Bond Stereocenter Count1
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameChlorpheniramine maleate
    Drug LabelEd Chlortan Tablets are yellow, round, plain bottom, debossed "PH above 012" on top....
    Active IngredientChlorpheniramine maleate
    Dosage FormTablet, extended release
    RouteOral
    Strength12mg
    Market StatusOver the Counter
    CompanyAvanthi

    2 of 2  
    Drug NameChlorpheniramine maleate
    Drug LabelEd Chlortan Tablets are yellow, round, plain bottom, debossed "PH above 012" on top....
    Active IngredientChlorpheniramine maleate
    Dosage FormTablet, extended release
    RouteOral
    Strength12mg
    Market StatusOver the Counter
    CompanyAvanthi

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Histamine H1 Antagonists

    Drugs that selectively bind to but do not activate histamine H1 receptors, thereby blocking the actions of endogenous histamine. Included here are the classical antihistaminics that antagonize or prevent the action of histamine mainly in immediate hypersensitivity. They act in the bronchi, capillaries, and some other smooth muscles, and are used to prevent or allay motion sickness, seasonal rhinitis, and allergic dermatitis and to induce somnolence. The effects of blocking central nervous system H1 receptors are not as well understood. (See all compounds classified as Histamine H1 Antagonists.)

    Antipruritics

    Agents, usually topical, that relieve itching (pruritus). (See all compounds classified as Antipruritics.)

    Anti-Allergic Agents

    Agents that are used to treat allergic reactions. Most of these drugs act by preventing the release of inflammatory mediators or inhibiting the actions of released mediators on their target cells. (From AMA Drug Evaluations Annual, 1994, p475) (See all compounds classified as Anti-Allergic Agents.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Histamine-1 Receptor Antagonist [EPC]; Histamine H1 Receptor Antagonists [MoA]

    API Reference Price

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Contact No: 78313"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1666895400,"product":"CHLORPHENIRAMINE MALEATE","address":"SURVEY NO.225, SAMPANBOLE VILLAGE, SHAMIRPET MANDAL","city":"MEDCHAL-MALKAKGIRI DISTRICT,TELANGA","supplier":"SPERA NEXUS","supplierCountry":"JAPAN","foreign_port":"NA","customer":"ALPHAMED FORMULATIONS PRIVATE ","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"188","totalValueFC":"1916.9","currency":"USD","unitRateINR":"15773.2","date":"28-Oct-2022","totalValueINR":"157732","totalValueInUsd":"1916.9","indian_port":"HYDERABAD AIR","hs_no":"29333914","bill_no":"3058204","productDescription":"API","marketType":"REGULATED MARKET","country":"JAPAN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"SURVEY NO.225, SAMPANBOLE VILLAGE, SHAMIRPET MANDAL"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706639400,"product":"REIMPORT FOR PROCESS - CHLORPHENIRAMINE MALEATE USP (VIDE S\/B NO. 5798946 DT. 29.11.2022)(QTY: 48 DRUMS OF 25 KGS)","address":"PLOT NO. : T-100, MIDC-TARAPUR,","city":"DIST - THANE, MAHARASHTRA.","supplier":"CIMED INDUSTRIA SA","supplierCountry":"INDIA","foreign_port":"SANTOS","customer":"KESHAVA ORGANICS","customerCountry":"INDIA","quantity":"1198.65","actualQuantity":"1198.65","unit":"KGS","unitRateFc":"27.5","totalValueFC":"35156.8","currency":"USD","unitRateINR":"2437.7","date":"31-Jan-2024","totalValueINR":"2921937.37","totalValueInUsd":"35156.8","indian_port":"JNPT","hs_no":"29333914","bill_no":"9907557","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"SANTOS","supplierAddress":"AV. CORONEL ARMANDO RUBENS STORINO,2750 BAIRRO ALGODAO DOCE- POUSO ALEGRE MG Brazil","customerAddress":"PLOT NO. : T-100, MIDC-TARAPUR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706639400,"product":"REIMPORT FOR PROCESS - CHLORPHENIRAMINE MALEATE USP (VIDE S\/B NO. 6325424 DT. 21.12.2022)(QTY: 10 DRUMS OF 25 KGS)","address":"PLOT NO. : T-100, MIDC-TARAPUR,","city":"DIST - THANE, MAHARASHTRA.","supplier":"CIMED INDUSTRIA SA","supplierCountry":"INDIA","foreign_port":"SANTOS","customer":"KESHAVA ORGANICS","customerCountry":"INDIA","quantity":"249.73","actualQuantity":"249.73","unit":"KGS","unitRateFc":"27.5","totalValueFC":"7324.7","currency":"USD","unitRateINR":"2437.7","date":"31-Jan-2024","totalValueINR":"608764.55","totalValueInUsd":"7324.7","indian_port":"JNPT","hs_no":"29333914","bill_no":"9907557","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"SANTOS","supplierAddress":"AV. CORONEL ARMANDO RUBENS STORINO,2750 BAIRRO ALGODAO DOCE- POUSO ALEGRE MG Brazil","customerAddress":"PLOT NO. : T-100, MIDC-TARAPUR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725388200,"product":"CHLORPHENIRAMINE MALEATE USP - (RE-IMPORT MATERIAL SB NO: 7483002 DT. 13.02.2024) BATCH NO. SLL\/C\/0124014-A, AND SLL\/C\/0","address":"207\/208,UDYOG BHAVAN,SONAWALA ROAD,","city":"MUMBAI ,MAHARASHTRA","supplier":"AMPAK COMPANY INC.","supplierCountry":"INDIA","foreign_port":"NEW YORK","customer":"SUPRIYA LIFESCIENCE","customerCountry":"INDIA","quantity":"900.00","actualQuantity":"900","unit":"KGS","unitRateFc":"65","totalValueFC":"60195.9","currency":"USD","unitRateINR":"5605","date":"04-Sep-2024","totalValueINR":"5044487.43","totalValueInUsd":"60195.9","indian_port":"JNPT","hs_no":"29333914","bill_no":"5413791","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NEW YORK","supplierAddress":"1890 PALMER AVE, SUITE 203 LARCHMON T, N.Y. 10538. SDNF UNITED STATES UNITED STATES","customerAddress":"207\/208,UDYOG BHAVAN,SONAWALA ROAD,"}]
    05-Jan-2021
    30-Mar-2025
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - SOLUTION;ORAL - 4MG/5ML;5MG/5ML

    USFDA APPLICATION NUMBER - 204307

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    DOSAGE - TABLET;ORAL - 2MG;200MG;30MG

    USFDA APPLICATION NUMBER - 21441

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    DOSAGE - TABLET;ORAL - 4MG;200MG;10MG

    USFDA APPLICATION NUMBER - 22113

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    DOSAGE - SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG...DOSAGE - SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 22439

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 7638

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    DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 8MG ...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 7638

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    ABOUT THIS PAGE

    Looking for 113-92-8 / Chlorpheniramine Maleate API manufacturers, exporters & distributors?

    Chlorpheniramine Maleate manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Chlorpheniramine Maleate

    Synonyms

    113-92-8, Chlorphenamine maleate, Neorestamin, Synistamin, Piriton, Chlor-trimeton

    Cas Number

    113-92-8

    Unique Ingredient Identifier (UNII)

    V1Q0O9OJ9Z

    About Chlorpheniramine Maleate

    A histamine H1 antagonist used in allergic reactions, hay fever, rhinitis, urticaria, and asthma. It has also been used in veterinary applications. One of the most widely used of the classical antihistaminics, it generally causes less drowsiness and sedation than PROMETHAZINE.

    Sine off Manufacturers

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

    Sine off Suppliers

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

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

    Sine off USDMF

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

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

    click here to find a list of Sine off suppliers with USDMF on PharmaCompass.

    Sine off JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Sine off Drug Master File in Japan (Sine off JDMF) empowers Sine off API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Sine off JDMF during the approval evaluation for pharmaceutical products. At the time of Sine off JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Sine off suppliers with JDMF on PharmaCompass.

    Sine off KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Sine off Drug Master File in Korea (Sine off KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sine off. The MFDS reviews the Sine off KDMF as part of the drug registration process and uses the information provided in the Sine off KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Sine off KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Sine off API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Sine off suppliers with KDMF on PharmaCompass.

    Sine off WC

    A Sine off written confirmation (Sine off WC) is an official document issued by a regulatory agency to a Sine off manufacturer, verifying that the manufacturing facility of a Sine off active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sine off APIs or Sine off finished pharmaceutical products to another nation, regulatory agencies frequently require a Sine off WC (written confirmation) as part of the regulatory process.

    click here to find a list of Sine off suppliers with Written Confirmation (WC) on PharmaCompass.

    Sine off 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 Sine off as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Sine off 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 Sine off 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 Sine off and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sine off NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Sine off suppliers with NDC on PharmaCompass.

    Sine off GMP

    Sine off 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 Sine off 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 Sine off GMP manufacturer or Sine off GMP API supplier for your needs.

    Sine off CoA

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

    Sine off CoA mostly includes findings from lab analyses of a specific batch. For each Sine off 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.

    Sine off may be tested according to a variety of international standards, such as European Pharmacopoeia (Sine off EP), Sine off JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sine off 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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