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Chemistry

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Also known as: 562-10-7, Decapryn, Doxylamine (succinate), Gittalun, Unisom, Doxylamine hydrogen succinate
Molecular Formula
C21H28N2O5
Molecular Weight
388.5  g/mol
InChI Key
KBAUFVUYFNWQFM-UHFFFAOYSA-N
FDA UNII
V9BI9B5YI2

Doxylamine Succinate
Doxylamine Succinate is a pyridine derivate histamine H1 antagonist with pronounced sedative properties. Doxylamine succinate competitively blocks the histamine H1 receptor and limits the typical allergic and anaphylactic responses, including bronchoconstriction, vasodilation, increased capillary permeability, and spasmodic contraction of gastrointestinal smooth muscle, caused by actions of histamine on bronchial and gastrointestinal smooth muscles, and on capillaries. This drug also prevents histamine-induced pain and itching of the skin and mucous membranes.
1 2D Structure

Doxylamine Succinate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
butanedioic acid;N,N-dimethyl-2-(1-phenyl-1-pyridin-2-ylethoxy)ethanamine
2.1.2 InChI
InChI=1S/C17H22N2O.C4H6O4/c1-17(20-14-13-19(2)3,15-9-5-4-6-10-15)16-11-7-8-12-18-16;5-3(6)1-2-4(7)8/h4-12H,13-14H2,1-3H3;1-2H2,(H,5,6)(H,7,8)
2.1.3 InChI Key
KBAUFVUYFNWQFM-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC(C1=CC=CC=C1)(C2=CC=CC=N2)OCCN(C)C.C(CC(=O)O)C(=O)O
2.2 Other Identifiers
2.2.1 UNII
V9BI9B5YI2
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

1. 562-10-7

2. Decapryn

3. Doxylamine (succinate)

4. Gittalun

5. Unisom

6. Doxylamine Hydrogen Succinate

7. Doxylamine Succinate Salt

8. Hoggar N

9. Doxy-sleep-aid

10. Evigoa D

11. A-h Injection

12. Decapryn Succinate

13. Doxylamine Succinate (1:1)

14. Alsadorm

15. Mereprine

16. Decapryn Succinate (1:1)

17. Alsodorm

18. Donormil

19. Donormyl

20. Dormidina

21. Meraprina

22. Nsc-74772

23. Doxylamine Succinate [usp]

24. V9bi9b5yi2

25. Butanedioic Acid;n,n-dimethyl-2-(1-phenyl-1-pyridin-2-ylethoxy)ethanamine

26. Mls000028417

27. 2-dimethylaminoethoxyphenylmethyl-2-picoline Succinate (1:1)

28. Chebi:82461

29. N,n-dimethyl-2-(1-phenyl-1-(pyridin-2-yl)ethoxy)ethanamine Succinate

30. Sedaplus

31. Smr000058436

32. Decapryn (tn)

33. Dsstox_cid_552

34. Doxylamine Succinate (usp)

35. Butanedioic Acid, Compd. With N,n-dimethyl-2-(1-phenyl-1-(2-pyridinyl)ethoxy)ethanamine (1:1)

36. Dsstox_rid_75656

37. Ethanamine, N,n-dimethyl-2-(1-phenyl-1-(2-pyridinyl)ethoxy)-, Butanedioate (1:1)

38. Dsstox_gsid_20552

39. Butanedioic Acid, Compd. Withn,n-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]ethanamine (1:1)other Ca Index Names:ethanamine, N,n-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-,butanedioate (1:1)

40. N,n-dimethyl-2-(1-phenyl-1-pyridin-2-ylethoxy)ethanamine Succinate

41. Topcare Sleep Aid

42. Butanedioic Acid, Compd. With N,n-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]ethanamine (1:1)

43. Ccris 4811

44. Sr-01000003036

45. Einecs 209-228-7

46. Equaline Sleep Aid

47. Mfcd00056168

48. Nsc 74772

49. Doxylamine Succinate Liquid

50. Unii-v9bi9b5yi2

51. Safetussin

52. Ai3-23993

53. Ncgc00017028-02

54. Cas-562-10-7

55. Prestwick_887

56. Dimethylaminoethoxy-methyl-benzyl-pyridine Succinate

57. Decamium

58. 2-dimethylaminoethoxyphenylmethyl-2-picoline Succinate

59. Opera_id_566

60. Phenyl2-pyridylmethyl-beta-n,n-dimethylaminoethyl Ether Succinate

61. 2-(alpha-(2-dimethylaminoethoxy)-alpha-methylbenzyl)pyridine Succinate

62. 2-(alpha(2-(dimethylamino)ethoxy)-alpha-methylbenzyl)pyridine Succinate (1:1)

63. Alpha-(2-dimethylaminoethoxy)-alpha-methyl-alpha-phenyl-2-picoline Acid Succinate

64. Pyridine, Succinate (1:1)

65. Mls000758288

66. Mls001076141

67. Mls001424137

68. Mls002222274

69. Schembl160443

70. Spectrum1500267

71. Chembl1200392

72. Dtxsid7020552

73. Doxylamine For System Suitability

74. Hms502k03

75. Doxylamine Succinate [mi]

76. Hms1568e15

77. Hms1920k04

78. Hms2051f14

79. Hms2091b09

80. Hms2095e15

81. Hms2231g05

82. Hms3261e17

83. Hms3370k04

84. Hms3393f14

85. Hms3652h19

86. Hms3712e15

87. Hms3885d13

88. Pharmakon1600-01500267

89. Doxylamine Succinate [iarc]

90. Bcp24067

91. Hy-a0069

92. Nsc74772

93. Doxylamine Succinate [vandf]

94. Tox21_113515

95. Tox21_202078

96. Tox21_302861

97. Tox21_500348

98. Ccg-38929

99. Doxylamine Succinate [mart.]

100. Nsc756752

101. S4240

102. Doxylamine Succinate [usp-rs]

103. Doxylamine Succinate [who-dd]

104. Akos025310916

105. Butanedioic Acid,n,n-dimethyl-2-(1-phenyl-1-pyridin-2-ylethoxy)ethanamine

106. Tox21_113515_1

107. Ac-4487

108. Ccg-101033

109. Cs-3232

110. Lp00348

111. Nc00283

112. Nsc-756752

113. Pyridine, 2-(alpha-(2-(dimethylamino)ethoxy)-alpha-methylbenzyl)-, Succinate (1:1)

114. Doxylamine Succinate [green Book]

115. Ncgc00016140-02

116. Ncgc00016140-03

117. Ncgc00016140-04

118. Ncgc00021147-11

119. Ncgc00089789-03

120. Ncgc00093785-01

121. Ncgc00093785-02

122. Ncgc00093785-03

123. Ncgc00256517-01

124. Ncgc00259627-01

125. Ncgc00261033-01

126. As-13661

127. Doxylamine Succinate [orange Book]

128. Succinic Acid, Compd. With 2-(alpha-(2-(dimethylamino)ethoxy)-alpha-methylbenzyl)pyridine (1:1)

129. Db-052868

130. Doxylamine Succinate [usp Monograph]

131. D5583

132. Eu-0100348

133. Ft-0625595

134. Ft-0667789

135. Sw197008-4

136. Wln: T6nj Bx1&r&o2n1&1 &ov2vo

137. Bonjesta Component Doxylamine Succinate

138. Diclegis Component Doxylamine Succinate

139. Bendectin Component Doxylamine Succinate

140. C19414

141. D 3775

142. D-9200

143. D02327

144. D81886

145. Diclectin Component Doxylamine Succinate

146. Doxylamine Succinate Component Of Bonjesta

147. Doxylamine Succinate Component Of Diclegis

148. Doxylamine Hydrogen Succinate [ep Impurity]

149. Doxylamine Succinate Component Of Bendectin

150. Doxylamine Hydrogen Succinate [ep Monograph]

151. Sr-01000003036-2

152. Sr-01000003036-6

153. Sr-01000003036-9

154. (dimethylamino)ethoxy-methyl-benzyl-pyridine Succinate

155. F2173-1155

156. [[[(2-dimethylamino)ethoxy]phenyl]methyl]-2-picoline Succinate

157. 2-[a-[2-(dimethylamino)ethoxy]-a-methylbenzyl]pyridine Succinate

158. Doxylamine Hydrogen Succinate 1.0 Mg/ml In Methanol (as Free Base)

159. Doxylamine Succinate, United States Pharmacopeia (usp) Reference Standard

160. N,n-dimethyl-2-(1-phenyl-1-(pyridin-2-yl)ethoxy)ethanaminesuccinate

161. Phenyl2-pyridylmethyl-(.beta.-n,n-dimethylamino)ethyl Ether Succinate

162. 2-(.alpha.(2-(dimethylamino)ethoxy)-.alpha.-methylbenzyl)pyridine Succinate (1:1)

163. 2-[[.alpha.-(2-dimethylamino)ethoxy]-.alpha.-methylbenzyl]pyridine Succinate

164. Butanedioic Acid,n-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]ethanamine (1:1)

165. Doxylamine For System Suitability, European Pharmacopoeia (ep) Reference Standard

166. Doxylamine Hydrogen Succinate, European Pharmacopoeia (ep) Reference Standard

167. Doxylamine Succinate, Pharmaceutical Secondary Standard; Certified Reference Material

168. Doxylamine Succinate Solution, 1.0 Mg/ml In Methanol (as Free Base), Ampule Of 1 Ml, Certified Reference Material

169. N,n-dimethyl-2-((1rs)-1-phenyl-1-(pyridin-2-yl)ethoxy(ethanamine Hydrogen Butanedioate

170. Succinic Acid, Compd. With 2-[.alpha.-[2-(dimethylamino)ethoxy]-.alpha.-methylbenzyl]pyridine (1:1)

2.4 Create Date
2005-03-26
3 Chemical and Physical Properties
Molecular Weight 388.5 g/mol
Molecular Formula C21H28N2O5
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count7
Rotatable Bond Count9
Exact Mass388.19982200 g/mol
Monoisotopic Mass388.19982200 g/mol
Topological Polar Surface Area100 Ų
Heavy Atom Count28
Formal Charge0
Complexity369
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count1
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 NameDoxylamine succinate
Drug LabelTAMPER EVIDENT: Do not use if printed foil inner seal under bottle cap is broken or missing. Failure to follow these warnings could result in serious consequences.www.sambrosadreams.comProcessed in the United States with Foreign IngredientsDist. by S...
Active IngredientDoxylamine succinate
Dosage FormTablet
RouteOral
Strength25mg
Market StatusOver the Counter
CompanyPerrigo; Lnk

2 of 4  
Drug NameUnisom
PubMed HealthDoxylamine (By mouth)
Drug ClassesRespiratory Agent
Active IngredientDoxylamine succinate
Dosage FormTablet
RouteOral
Strength25mg
Market StatusOver the Counter
CompanyChattem

3 of 4  
Drug NameDoxylamine succinate
Drug LabelTAMPER EVIDENT: Do not use if printed foil inner seal under bottle cap is broken or missing. Failure to follow these warnings could result in serious consequences.www.sambrosadreams.comProcessed in the United States with Foreign IngredientsDist. by S...
Active IngredientDoxylamine succinate
Dosage FormTablet
RouteOral
Strength25mg
Market StatusOver the Counter
CompanyPerrigo; Lnk

4 of 4  
Drug NameUnisom
PubMed HealthDoxylamine (By mouth)
Drug ClassesRespiratory Agent
Active IngredientDoxylamine succinate
Dosage FormTablet
RouteOral
Strength25mg
Market StatusOver the Counter
CompanyChattem

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.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Histamine Receptor Antagonists [MoA]; Antihistamine [EPC]

Listed Suppliers

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Virtual BoothPharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.

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Doxylamine Succinate

About the Company : Pharm-Rx has earned an outstanding reputation since its establishment in 1991, serving as a reputable importer and distributor of active ingredients to the pharmaceutical, nutritio...

Pharm-Rx has earned an outstanding reputation since its establishment in 1991, serving as a reputable importer and distributor of active ingredients to the pharmaceutical, nutritional supplement, and food industries. The company maintains an exceptionally selective approach to its suppliers, personally visiting manufacturers overseas to ensure the highest standards. The sustained growth of Pharm-Rx can be attributed to its steadfast commitment to three core values: quality ingredients, competitive pricing, and unparalleled customer service.
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LGM Pharma

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Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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Doxylamine Succinate

About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
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Virtual BoothRochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

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Doxylamine Succinate

About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...

Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quality ingredients manufactured in China. Headquartered in the Hauppauge, New York, Rochem has 16 offices spread across the globe to cater to the needs of its customers. Rochem’s operations are fully cGMP compliant and has been audited by the USFDA as well as several multinational organizations. It also trains and audits its partners to ensure all of their technologies and systems are FDA-compliant.
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Virtual BoothJai Radhe Sales is your partner for all your sourcing needs.

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Doxylamine Succinate

About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...

Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete sourcing solutions for pharmaceutical products from India, including technical and regulatory assistance. It believes in providing its customers with high-quality products at reasonable prices. It has always endeavored to achieve global standards in the field of pharmaceuticals and has carved out a niche for itself through new methods based on current market needs. Today, it has established itself as a truly global company, with exports to almost every continent.
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Virtual BoothMalladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.

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Doxylamine Succinate

About the Company : Malladi Drugs & Pharmaceuticals Ltd was founded in 1980 by microbiologist Mr. M L N Sastry. Within a few years, Malladi established itself as a leader in manufacturing ephedrine an...

Malladi Drugs & Pharmaceuticals Ltd was founded in 1980 by microbiologist Mr. M L N Sastry. Within a few years, Malladi established itself as a leader in manufacturing ephedrine and pseudoephedrine salts. Today, it is the leading manufacturer of APIs in the cough and cold segment. It also has a dominant presence in several therapeutic segments like antihistamines, anti-convulsants, anti-depressants and anxiolytics (CNS). Malladi exports its products to around 60 countries and over 85% of its revenue is generated from exports. Its manufacturing facilities have been approved by the FDA, EDQM, KFDA, TGA and various other regulatory agencies.
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Virtual BoothTenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.

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About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...

Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opportunities grew, it was felt that the proprietorship firm had outlived its usefulness and that it needed a corporate structure. So, Tenatra Chemie Private Limited (TCPL) was incorporated in 2002. Since then, the company has come a long way, gaining valuable experience and knowledge in the fields of chemicals and pharmaceuticals in India.
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07

Harika Drugs

India
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Virtual BoothHarika Drugs has been providing a qualitative range of Bulk Drugs/ APIs since 1993.

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Doxylamine Succinate

About the Company : Our endeavours also lie in the import, and domestic sourcing of raw materials from reliable vendors of the market. We have an excellent infrastructure with world class cGMP facilit...

Our endeavours also lie in the import, and domestic sourcing of raw materials from reliable vendors of the market. We have an excellent infrastructure with world class cGMP facilities. Our manufacturing unit is based near Hyderabad, which is equipped with the latest production equipment to produce super quality Bulk Drugs/APIs. Spread on the area of 18000 sq. m., our factory has high production capacity and as a result of which we are able to satisfy immediate and bulk requirements of our clients.
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Virtual BoothDelivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.

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Doxylamine Succinate

About the Company : Zeal MediPharma is a globally recognized Star One Export House, serving customers in over 50 countries for more than two decades. We specialize in sourcing and exporting high-quali...

Zeal MediPharma is a globally recognized Star One Export House, serving customers in over 50 countries for more than two decades. We specialize in sourcing and exporting high-quality APIs for human and veterinary use, along with drug intermediates, excipients, and semi-finished formulations such as pellets and DC granules. Our diverse portfolio also includes herbal extracts, phytochemicals, nutraceuticals, food and feed ingredients, agrochemicals, preservatives, surfactants, and specialty chemicals. Committed to excellence, we deliver reliable, high-quality solutions to meet the evolving needs of global healthcare and industry.
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Virtual BoothHonour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.

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Doxylamine Succinate

About the Company : Honour is a leading global CDMO and a trusted manufacturer of specialty chemicals and ingredients. With seven world-class facilities built to meet global safety and quality standar...

Honour is a leading global CDMO and a trusted manufacturer of specialty chemicals and ingredients. With seven world-class facilities built to meet global safety and quality standards, we are committed to delivering excellence with innovative, holistic solutions to clients across the globe by leveraging our expertise in chemistry. Operating through our two core verticals - Honour Synthesis and Honour Specialty, we embrace the science of partnership and possibilities. Our team of over 2,500 professionals collaborates closely with pharmaceutical, biotechnology, and specialty industries worldwide to develop practical, scalable solutions.
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Doxylamine Succinate

About the Company : Aspire group was established in the year 2000 with a motto of quality drug for better health of all. In its journey till date, aspire has developed enormous reputation, consistent ...

Aspire group was established in the year 2000 with a motto of quality drug for better health of all. In its journey till date, aspire has developed enormous reputation, consistent growth, unique technologies and world class quality healthcare products. Aspire is pioneer in manufacturing and sourcing unique healthcare products. True to the statement, “Where the future started yesterday” with a foresight on the current trends in the healthcare market, Aspire has grown from strength combining its research strength, Human resources and well established quality systems. Aspire has crossed numerous milestones in a comparatively short period since its inception.
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SDNF Spain","customerAddress":"54-A, SIR MATHURADAS VASANJI ROAD"}]
12-Jan-2022
26-Jul-2025
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ABOUT THIS PAGE

Looking for 562-10-7 / Doxylamine Succinate API manufacturers, exporters & distributors?

Doxylamine Succinate manufacturers, exporters & distributors 1

15

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

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

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

API | Excipient name

Doxylamine Succinate

Synonyms

562-10-7, Decapryn, Doxylamine (succinate), Gittalun, Unisom, Doxylamine hydrogen succinate

Cas Number

562-10-7

Unique Ingredient Identifier (UNII)

V9BI9B5YI2

About Doxylamine Succinate

Doxylamine Succinate is a pyridine derivate histamine H1 antagonist with pronounced sedative properties. Doxylamine succinate competitively blocks the histamine H1 receptor and limits the typical allergic and anaphylactic responses, including bronchoconstriction, vasodilation, increased capillary permeability, and spasmodic contraction of gastrointestinal smooth muscle, caused by actions of histamine on bronchial and gastrointestinal smooth muscles, and on capillaries. This drug also prevents histamine-induced pain and itching of the skin and mucous membranes.

Doxylamine succinate salt Manufacturers

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

Doxylamine succinate salt Suppliers

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

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

Doxylamine succinate salt USDMF

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

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

click here to find a list of Doxylamine succinate salt suppliers with USDMF on PharmaCompass.

Doxylamine succinate salt CEP

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

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

Doxylamine succinate salt WC

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

click here to find a list of Doxylamine succinate salt suppliers with Written Confirmation (WC) on PharmaCompass.

Doxylamine succinate salt 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 Doxylamine succinate salt as an active pharmaceutical ingredient (API).

Finished drug products

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

click here to find a list of Doxylamine succinate salt suppliers with NDC on PharmaCompass.

Doxylamine succinate salt GMP

Doxylamine succinate salt 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 Doxylamine succinate salt 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 Doxylamine succinate salt GMP manufacturer or Doxylamine succinate salt GMP API supplier for your needs.

Doxylamine succinate salt CoA

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

Doxylamine succinate salt CoA mostly includes findings from lab analyses of a specific batch. For each Doxylamine succinate salt 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.

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