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    Chemistry

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    Also known as: 147-24-0, Diphenhydramine hcl, Dimedrol, Allergival, Carphenamine, Bendylate
    Molecular Formula
    C17H22ClNO
    Molecular Weight
    291.8  g/mol
    InChI Key
    PCHPORCSPXIHLZ-UHFFFAOYSA-N
    FDA UNII
    TC2D6JAD40
    Diphenhydramine Hydrochloride
    A histamine H1 antagonist used as an antiemetic, antitussive, for dermatoses and pruritus, for hypersensitivity reactions, as a hypnotic, an antiparkinson, and as an ingredient in common cold preparations. It has some undesired antimuscarinic and sedative effects.
    1 2D Structure

    Diphenhydramine Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-benzhydryloxy-N,N-dimethylethanamine;hydrochloride
    2.1.2 InChI
    InChI=1S/C17H21NO.ClH/c1-18(2)13-14-19-17(15-9-5-3-6-10-15)16-11-7-4-8-12-16;/h3-12,17H,13-14H2,1-2H3;1H
    2.1.3 InChI Key
    PCHPORCSPXIHLZ-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CN(C)CCOC(C1=CC=CC=C1)C2=CC=CC=C2.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    TC2D6JAD40
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 2-diphenylmethoxy-n,n-dimethylethylamine

    2. Allerdryl

    3. Benadryl

    4. Benhydramin

    5. Benylin

    6. Benzhydramine

    7. Citrate, Diphenhydramine

    8. Dimedrol

    9. Diphenhydramine

    10. Diphenhydramine Citrate

    11. Diphenhydramine Citrate (1:1)

    12. Diphenylhydramin

    13. Diphenylhydramine

    14. Dormin

    15. Hydrochloride, Diphenhydramine

    2.3.2 Depositor-Supplied Synonyms

    1. 147-24-0

    2. Diphenhydramine Hcl

    3. Dimedrol

    4. Allergival

    5. Carphenamine

    6. Bendylate

    7. Carphenex

    8. Cathejell

    9. Denydryl

    10. Diphamine

    11. Eldadryl

    12. Fenylhist

    13. Noctomin

    14. Ambenyl

    15. Felben

    16. Prodryl

    17. Bena

    18. Diphenhydramine.hcl

    19. Diphenhydramine (hydrochloride)

    20. Allergan

    21. Benylin

    22. Dibenil

    23. Hydramine

    24. Paradryl

    25. Restamin

    26. Silphen

    27. Vicks Formula 44

    28. Beldin

    29. Benzhydramine Hydrochloride

    30. Diphen

    31. Belix

    32. Dobacen Hydrochloride

    33. Dimedrol Hydrochloride

    34. Benzantin Hydrochloride

    35. Difenhydramine Hydrochloride

    36. 2-(benzhydryloxy)-n,n-dimethylethanamine Hydrochloride

    37. Benzantin

    38. Dimedrolum

    39. Diphenylhydramine Hydrochloride

    40. Nci-c56075

    41. Ethanamine, 2-(diphenylmethoxy)-n,n-dimethyl-, Hydrochloride

    42. 2-(benzhydryloxy)-n,n-dimethylethylamine Hydrochloride

    43. Mfcd00012479

    44. Diphenhydramine Hcl (benadryl)

    45. 2-(diphenylmethoxy)-n,n-dimethylethylamine Hydrochloride

    46. N-(2-diphenylmethoxyethyl)-n,n-dimethylamine Hydrochloride

    47. Nsc-33299

    48. Tc2d6jad40

    49. Mls000028428

    50. 2-benzhydryloxy-n,n-dimethylethanamine;hydrochloride

    51. 147-24-0 (hcl)

    52. Sedopretten

    53. Halbmond

    54. Histacyl

    55. Smr000058353

    56. Wehydryl

    57. Resmin

    58. Vena

    59. Dsstox_cid_537

    60. Sekundal-d

    61. 2-diphenylmethoxy-n,n-dimethylethylamine Hydrochloride

    62. Beta-dimethylaminoethyl Benzhydryl Ether Hydrochloride

    63. Dsstox_rid_75646

    64. Dsstox_gsid_20537

    65. Alpha-hydroxydiphenylmethane-beta-dimethylaminoethyl Ether Hydrochloride

    66. Diphenhydramine Hydrochloride 100 Microg/ml In Acetonitrile

    67. Dipjemhist

    68. 2-[(diphenylmethyl)oxy]-n,n-dimethylethanamine Hydrochloride

    69. Banophen

    70. Asdrin

    71. Benadryl Preservative Free

    72. Chebi:4637

    73. Sk-diphenhydramine

    74. Sleep-eze-3

    75. Benadryl Hydrochloride

    76. Ccris 2383

    77. Sr-01000003069

    78. Ncgc00015335-09

    79. Cas-147-24-0

    80. Einecs 205-687-2

    81. Nsc 33299

    82. Unii-tc2d6jad40

    83. Tylenol Pm Tablets/caplets

    84. Tylenol Cold Night Time Liquid

    85. Antitussive Agents

    86. Benadryl (tn)

    87. Prestwick_177

    88. Bayer Select Night Time Pain Relief

    89. Component Of Caladryl

    90. Benadril Hydrochloride

    91. Benzhydrol, Beta-dimethylaminoethyl Ether Hydrochloride

    92. Dimedrol-hydrochloride

    93. Difenidramina Cloridrato

    94. Cpd000058353

    95. Opera_id_152

    96. Component Of Bena-fedrin

    97. Dimethylamine Benzhydryl Ester Hydrochloride

    98. Diphenhydramine Hydrochloride [usp:ban:jan]

    99. Diphenhydramine Hydrochloride Preservative Free

    100. Cloridrato De Difenidramina

    101. Diphenydramine Hydrochloride

    102. Chembl1620

    103. Regid_for_cid_8980

    104. Schembl17071

    105. Mls000758216

    106. Mls001148114

    107. Mls001423951

    108. Mls002222180

    109. Spectrum1500256

    110. Dtxsid4020537

    111. Hy-b0303a

    112. Diphenhydramine Hydrochloride,(s)

    113. Diphenhydramine Hcl [inci]

    114. Hms1568m11

    115. Hms1920i06

    116. Pharmakon1600-01500256

    117. Bcp13546

    118. Nsc33299

    119. Tox21_112991

    120. Tox21_201472

    121. Tox21_300611

    122. Tox21_500377

    123. Ccg-39755

    124. Nsc756729

    125. S1866

    126. Akos005287308

    127. Ac-3449

    128. Lp00377

    129. Nc00060

    130. Nsc-756729

    131. Ncgc00024414-05

    132. Ncgc00093809-01

    133. Ncgc00093809-02

    134. Ncgc00093809-03

    135. Ncgc00093809-04

    136. Ncgc00093809-05

    137. Ncgc00254264-01

    138. Ncgc00259023-01

    139. Ncgc00261062-01

    140. As-12088

    141. Diphenhydramine Hydrochloride (jp17/usp)

    142. Diphenhydramine Hydrochloride [mi]

    143. Sy010546

    144. 2-benzhydryloxy-n,n-dimethylethanamine Hcl

    145. Diphenhydramine Hydrochloride [jan]

    146. Wln: 1n1 & 2oyr & R & Gh

    147. 4-acetoxy-3,5-dimethoxybenzoicacid

    148. D0423

    149. Diphenhydramine Hydrochloride [mart.]

    150. Diphenhydramine Hydrochloride [vandf]

    151. Eu-0100377

    152. Ft-0652576

    153. Sw198731-2

    154. Diphenhydramine Hydrochloride [usp-rs]

    155. Diphenhydramine Hydrochloride [who-dd]

    156. Diphenhydramine Hydrochloride, >=98% (hplc)

    157. C07784

    158. D 3630

    159. D00669

    160. Diphenhydramine Hydrochloride, Analytical Standard

    161. N-(2-diphenylmethoxyethyl)-n,n-dimethylamine Hcl

    162. Diphenhydramine Hydrochloride [ep Impurity]

    163. Diphenhydramine Hydrochloride [orange Book]

    164. Diphenhydramine Hydrochloride [ep Monograph]

    165. Diphenhydramine Hydrochloride [usp Monograph]

    166. Q-201003

    167. Sr-01000003069-2

    168. 2-(benzhydryloxy)-n,n-dimethylethanaminehydrochloride

    169. 2-benzhydryloxy-n,n-dimethylethanamine;hydron;chloride

    170. 2-diphenylmethoxy-n,n-dimethylethanamine Hydrochloride

    171. Q26841258

    172. Sr-01000003069-10

    173. .beta.-dimethylaminoethyl Benzhydryl Ether Hydrochloride

    174. 2-(benzhydryloxy)-n,n-dimethylethan-1-amine Hydrochloride

    175. Ethylamine,n-dimethyl-2-(diphenylmethoxy)-, Hydrochloride

    176. Diphenhydramine Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)

    177. Ethanamine, 2-(diphenylmethoxy)-n,n-dimethyl-, Hydrochloride (1:1)

    178. .alpha.-hydroxydiphenylmethane-.beta.-dimethylaminoethyl Ether Hydrochloride

    179. Diphenhydramine Hydrochloride, British Pharmacopoeia (bp) Reference Standard

    180. Diphenhydramine Hydrochloride, European Pharmacopoeia (ep) Reference Standard

    181. Diphenhydramine Hydrochloride, United States Pharmacopeia (usp) Reference Standard

    182. 8052-21-9

    183. Diphenhydramine Hydrochloride Solution, 1.0 Mg/ml In Methanol (as Free Base), Ampule Of 1 Ml, Certified Reference Material

    184. Diphenhydramine Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 291.8 g/mol
    Molecular Formula C17H22ClNO
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count2
    Rotatable Bond Count6
    Exact Mass291.1389920 g/mol
    Monoisotopic Mass291.1389920 g/mol
    Topological Polar Surface Area12.5 Ų
    Heavy Atom Count20
    Formal Charge0
    Complexity211
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameDiphenhydramine hydrochloride
    Drug LabelDiphenhydramine Hydrochloride is an antihistamine drug having the chemical name 2-(diphenylmethoxy)-N, N-dimethylethylamine hydrochloride. It occurs as a white, odorless crystalline powder and is freely soluble in water and alcohol. The structural fo...
    Active IngredientDiphenhydramine hydrochloride
    Dosage FormElixir; Injectable; Capsule
    RouteInjection; Oral
    Strength50mg/ml; 50mg; 12.5mg/5ml
    Market StatusPrescription
    CompanyHospira; Hikma Maple; Mylan Institutional; Pharm Assoc; App Pharms; Barr

    2 of 4  
    Drug NameDiphenhydramine hydrochloride preservative free
    Active IngredientDiphenhydramine hydrochloride
    Dosage FormInjectable
    RouteInjection
    Strength50mg/ml
    Market StatusPrescription
    CompanyBd Rx

    3 of 4  
    Drug NameDiphenhydramine hydrochloride
    Drug LabelDiphenhydramine Hydrochloride is an antihistamine drug having the chemical name 2-(diphenylmethoxy)-N, N-dimethylethylamine hydrochloride. It occurs as a white, odorless crystalline powder and is freely soluble in water and alcohol. The structural fo...
    Active IngredientDiphenhydramine hydrochloride
    Dosage FormElixir; Injectable; Capsule
    RouteInjection; Oral
    Strength50mg/ml; 50mg; 12.5mg/5ml
    Market StatusPrescription
    CompanyHospira; Hikma Maple; Mylan Institutional; Pharm Assoc; App Pharms; Barr

    4 of 4  
    Drug NameDiphenhydramine hydrochloride preservative free
    Active IngredientDiphenhydramine hydrochloride
    Dosage FormInjectable
    RouteInjection
    Strength50mg/ml
    Market StatusPrescription
    CompanyBd Rx

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Anesthetics, Local

    Drugs that block nerve conduction when applied locally to nerve tissue in appropriate concentrations. They act on any part of the nervous system and on every type of nerve fiber. In contact with a nerve trunk, these anesthetics can cause both sensory and motor paralysis in the innervated area. Their action is completely reversible. (From Gilman AG, et. al., Goodman and Gilman's The Pharmacological Basis of Therapeutics, 8th ed) Nearly all local anesthetics act by reducing the tendency of voltage-dependent sodium channels to activate. (See all compounds classified as Anesthetics, Local.)

    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.)

    Hypnotics and Sedatives

    Drugs used to induce drowsiness or sleep or to reduce psychological excitement or anxiety. (See all compounds classified as Hypnotics and Sedatives.)

    Antiemetics

    Drugs used to prevent NAUSEA or VOMITING. (See all compounds classified as Antiemetics.)

    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.)

    Sleep Aids, Pharmaceutical

    Drugs used to induce SLEEP, prevent SLEEPLESSNESS, or treat SLEEP INITIATION AND MAINTENANCE DISORDERS. (See all compounds classified as Sleep Aids, Pharmaceutical.)

    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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MAHARASHTRA,? 400002, N\/A","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734978600,"product":"ACTIVE PHARMACEUTICAL INGREDIENT - DIPHENHYDRAMINE HYDROCHLORIDE USP","address":"207\/208,UDYOG BHAVAN,SONAWALA ROAD,","city":"MUMBAI ,MAHARASHTRA","supplier":"SUPRIYA LIFESCIENCE","supplierCountry":"INDIA","foreign_port":"KINGSTON","customer":"CONSIGNEE","customerCountry":"JAMAICA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"34","totalValueFC":"2385.3","currency":"USD","unitRateINR":2026.7550000000001,"date":"24-Dec-2024","totalValueINR":"202675.5","totalValueInUsd":"2385.3","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"6714366","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"JAMAICA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"207\/208,UDYOG BHAVAN,SONAWALA ROAD,, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1735583400,"product":"DIPHENHYDRAMINE HYDROCHLORIDE EP11","address":"207\/208,UDYOG BHAVAN,SONAWALA ROAD,","city":"MUMBAI ,MAHARASHTRA","supplier":"SUPRIYA LIFESCIENCE","supplierCountry":"INDIA","foreign_port":"BUENOS AIRES","customer":"CONSIGNEE","customerCountry":"ARGENTINA","quantity":"1500.00","actualQuantity":"1500","unit":"KGS","unitRateFc":"17.1","totalValueFC":"25420.4","currency":"USD","unitRateINR":1439.9656,"date":"31-Dec-2024","totalValueINR":"2159948.4","totalValueInUsd":"25420.4","indian_port":"JNPT","hs_no":"29420090","bill_no":"6915427","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ARGENTINA","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"207\/208,UDYOG BHAVAN,SONAWALA ROAD,, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Import","activeIngredients":"DIPHENHYDRAMINE HYDROCHLORIDE","year":"2021","qtr":"Q2","strtotime":1619202600,"product":"(REIMPORT AND REEXPORT UNDER SECTION 69) DIPHENHYDRAMINE HYDROCHLORIDE (RETURNED GOODS DUE TO ORDER CANCELLATION)","address":"201 SWASTIK PLAZA, SUBHASH NAGAR,\\r\\nPOKHARAN RD NO 2,","city":"THANE WEST","supplier":"HENAN JUNSHUAI BIOTECHNOLOGY ","supplierCountry":"INDIA","foreign_port":"","customer":"ZEAL MEDIPHARMA EXPORT ","customerCountry":"INDIA","quantity":"2000.00","actualQuantity":"2000","unit":"KGS","unitRateFc":"12.5","totalValueFC":"25571.2","currency":"USD","unitRateINR":"951.9","date":"24-Apr-2021","totalValueINR":"1903750","totalValueInUsd":"25571.2","indian_port":"JNPT","hs_no":"29420090","bill_no":"3690583","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"","supplierAddress":"","customerAddress":"201 SWASTIK PLAZA, SUBHASH NAGAR,\\r\\nPOKHARAN RD NO 2,"},{"dataSource":"API Import","activeIngredients":"DIPHENHYDRAMINE HYDROCHLORIDE","year":"2021","qtr":"Q2","strtotime":1619289000,"product":"DIPHENHYDRAMINE HYDROCHLORIDE USP LOT: 8104369 DRUM LOCK: 0170695 PART NO. 93717","address":"PLOT NO.N- 39 AND PLOT NO. 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A30,A.I.E BALANAGAR HYDERABAD","city":"HYDERABAD,TELANGANA","supplier":"RECORDATI","supplierCountry":"ITALY","foreign_port":"NA","customer":"ANTHEA PHARMA PVT LTD","customerCountry":"INDIA","quantity":"0.85","actualQuantity":"0.85","unit":"KGS","unitRateFc":"2352.9","totalValueFC":"2034.8","currency":"USD","unitRateINR":"190470.6","date":"01-Aug-2022","totalValueINR":"161900","totalValueInUsd":"2034.8","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"9822078","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"SHANKAR TOWERS PLOT NO. A30,A.I.E BALANAGAR HYDERABAD"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1682274600,"product":"RETURN OF RAW MATERIAL-PHARMACEUTICAL RAW MATERIAL DIPHENHYDRAMINE HYDROCHLORIDE\/BATCH NO. 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    04-Jan-2021
    31-Dec-2024
    KGS
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - CAPSULE;ORAL - 25MG;EQ 200MG FREE AC...DOSAGE - CAPSULE;ORAL - 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT

    USFDA APPLICATION NUMBER - 21393

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    DOSAGE - INJECTABLE;INJECTION - 50MG/ML

    USFDA APPLICATION NUMBER - 80817

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    DOSAGE - ELIXIR;ORAL - 12.5MG/5ML

    USFDA APPLICATION NUMBER - 87513

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    ABOUT THIS PAGE

    Diphenhydramine Hydrochloride Manufacturers

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

    Diphenhydramine Hydrochloride Suppliers

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

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

    Diphenhydramine Hydrochloride USDMF

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

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

    click here to find a list of Diphenhydramine Hydrochloride suppliers with USDMF on PharmaCompass.

    Diphenhydramine Hydrochloride 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 Diphenhydramine Hydrochloride Drug Master File in Japan (Diphenhydramine Hydrochloride JDMF) empowers Diphenhydramine Hydrochloride 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 Diphenhydramine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Diphenhydramine Hydrochloride 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 Diphenhydramine Hydrochloride suppliers with JDMF on PharmaCompass.

    Diphenhydramine Hydrochloride KDMF

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

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

    After submitting a Diphenhydramine Hydrochloride 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 Diphenhydramine Hydrochloride API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Diphenhydramine Hydrochloride suppliers with KDMF on PharmaCompass.

    Diphenhydramine Hydrochloride CEP

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

    A Diphenhydramine Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Diphenhydramine Hydrochloride 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 Diphenhydramine Hydrochloride suppliers with CEP (COS) on PharmaCompass.

    Diphenhydramine Hydrochloride WC

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

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

    Diphenhydramine Hydrochloride 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 Diphenhydramine Hydrochloride as an active pharmaceutical ingredient (API).

    Finished drug products

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

    click here to find a list of Diphenhydramine Hydrochloride suppliers with NDC on PharmaCompass.

    Diphenhydramine Hydrochloride GMP

    Diphenhydramine Hydrochloride 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 Diphenhydramine Hydrochloride 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 Diphenhydramine Hydrochloride GMP manufacturer or Diphenhydramine Hydrochloride GMP API supplier for your needs.

    Diphenhydramine Hydrochloride CoA

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

    Diphenhydramine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Diphenhydramine Hydrochloride 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.

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