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Chemistry

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Also known as: 33386-08-2, Buspar, Buspirone hcl, Narol, Buspimen, Buspirone (hydrochloride)
Molecular Formula
C21H32ClN5O2
Molecular Weight
422.0  g/mol
InChI Key
RICLFGYGYQXUFH-UHFFFAOYSA-N
FDA UNII
207LT9J9OC

Buspirone Hydrochloride
An anxiolytic agent and serotonin receptor agonist belonging to the azaspirodecanedione class of compounds. Its structure is unrelated to those of the BENZODIAZAPINES, but it has an efficacy comparable to DIAZEPAM.
1 2D Structure

Buspirone Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
8-[4-(4-pyrimidin-2-ylpiperazin-1-yl)butyl]-8-azaspiro[4.5]decane-7,9-dione;hydrochloride
2.1.2 InChI
InChI=1S/C21H31N5O2.ClH/c27-18-16-21(6-1-2-7-21)17-19(28)26(18)11-4-3-10-24-12-14-25(15-13-24)20-22-8-5-9-23-20;/h5,8-9H,1-4,6-7,10-17H2;1H
2.1.3 InChI Key
RICLFGYGYQXUFH-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C1CCC2(C1)CC(=O)N(C(=O)C2)CCCCN3CCN(CC3)C4=NC=CC=N4.Cl
2.2 Other Identifiers
2.2.1 UNII
207LT9J9OC
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Anxut

2. Apo Buspirone

3. Apo-buspirone

4. Bespar

5. Busp

6. Buspar

7. Buspirone

8. Gen Buspirone

9. Gen-buspirone

10. Hydrochloride, Buspirone

11. Lin Buspirone

12. Lin-buspirone

13. Mj 9022 1

14. Mj-9022-1

15. Mj90221

16. N-(4-(4-(2-pyrimidinyl)-1-piperazinyl)butyl)-1-cyclopentanediacetamide

17. Neurosine

18. Novo Buspirone

19. Novo-buspirone

20. Nu Buspirone

21. Nu-buspirone

22. Pms Buspirone

23. Pms-buspirone

24. Ratio Buspirone

25. Ratio-buspirone

2.3.2 Depositor-Supplied Synonyms

1. 33386-08-2

2. Buspar

3. Buspirone Hcl

4. Narol

5. Buspimen

6. Buspirone (hydrochloride)

7. Mj 9022-1

8. 8-(4-(4-(pyrimidin-2-yl)piperazin-1-yl)butyl)-8-azaspiro[4.5]decane-7,9-dione Hydrochloride

9. Nsc-751138

10. Nsc-759571

11. Mj-9022-1

12. Mls000069796

13. N-(4-(4-(2-pyrimidinyl)-1-piperazinyl)butyl)-1,1-cyclopentanediacetamide Monohydrochloride

14. 207lt9j9oc

15. Apd405

16. Chebi:3224

17. Apd-405

18. Ansitec

19. Anxinil

20. Anxiolan

21. Busirone

22. Buspinol

23. Censpar

24. Effiplen

25. Establix

26. Kallmiren

27. Lucelan

28. Mabuson

29. Normaton

30. Smr000058186

31. Spamilan

32. Barpil

33. Bespar

34. Itagil

35. Nerbet

36. Sburol

37. Travin

38. Tutran

39. Biron

40. Relac

41. 33386-08-2 (hcl)

42. Apo-buspirone

43. 8-[4-(4-pyrimidin-2-ylpiperazin-1-yl)butyl]-8-azaspiro[4.5]decane-7,9-dione;hydrochloride

44. 8-azaspiro(4,5)decane-7,9-dione, 8-(4-(4-(2-pyrimidinyl)-1-piperazinyl)butyl)-, Monohydrochloride

45. 8-[4-(4-pyrimidin-2-ylpiperazin-1-yl)butyl]-8-azaspiro[4.5]decane-7,9-dione Hydrochloride

46. 8-{4-[4-(pyrimidin-2-yl)piperazin-1-yl]butyl}-8-azaspiro[4.5]decane-7,9-dione Hydrochloride

47. Buspirone Hydrochloride [usan]

48. Sr-01000075541

49. Einecs 251-489-4

50. Unii-207lt9j9oc

51. C21h31n5o2.hcl

52. Prestwick_711

53. Buspirone Hydrochloride [usan:usp]

54. Buspar (tn)

55. Mfcd00078569

56. Opera_id_707

57. 1,1-cyclopentanediacetimide, N-(4-(4-(2-pyrimidinyl)-1-piperazinyl)butyl)-, Hydrochloride

58. 8-(4-(4-(2-pyrimidinyl)-1-piperazinyl)butyl)-8-azaspiro(4.5)decane-7,9-dione Hydrochloride

59. Schembl41495

60. Mls001076085

61. Mls002548862

62. Buspirone Hydrochloride (usp)

63. Buspirone Hydrochloride Solution

64. Buspirone For System Suitability

65. Chembl1200399

66. Dtxsid1037193

67. Hms1569i19

68. Hms3750o03

69. Pharmakon1600-02300173

70. Apc-6002

71. Apc-6003

72. Bcp28463

73. Hy-b1115

74. Buspirone Hydrochloride [mi]

75. Tox21_500223

76. Buspirone Hydrochloride [jan]

77. Nsc751138

78. Nsc759571

79. S4256

80. Akos015962019

81. Ac-1905

82. Buspirone Hydrochloride [mart.]

83. Buspirone Hydrochloride [vandf]

84. Ccg-213652

85. Cs-4714

86. H05b847

87. Ks-5163

88. Lp00223

89. Nc00673

90. Nsc 751138

91. Nsc 759571

92. Buspirone Hydrochloride [usp-rs]

93. Buspirone Hydrochloride [who-dd]

94. Ncgc00093692-01

95. Ncgc00093692-02

96. Ncgc00260908-01

97. 8-(4-(4-(2-pyrimidinyl)-1-piperazinyl)butyl)-8-azaspiro(4.5)decane-7,9-dione Monohydrochloride

98. Buspirone Hydrochloride [orange Book]

99. Eu-0100223

100. Sw155073-5

101. Buspirone Hydrochloride [ep Monograph]

102. B 7148

103. Buspirone Hydrochloride [usp Monograph]

104. D00702

105. D96810

106. Q-200768

107. Sr-01000075541-1

108. Sr-01000075541-3

109. Sr-01000075541-7

110. Q27105997

111. Buspirone Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)

112. Buspirone Hydrochloride, European Pharmacopoeia (ep) Reference Standard

113. Buspirone Hydrochloride, United States Pharmacopeia (usp) Reference Standard

114. 8-azaspiro[4.5]decane-7, 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-, Monohydrochloride

115. Buspirone For System Suitability, European Pharmacopoeia (ep) Reference Standard

116. Buspirone Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

117. 1-[4-(7,9-dioxo-8-azaspiro[4.5]decan-8-yl)butyl]-4-(pyrimidin-2-yl)piperazin-1-ium Chloride

118. 8-[4-[4-(2-pyrimidinyl)-1-pipirazin Yl]butyl]-8-azaspiro[4,5]decane-7,9-dione Hydrochloride

119. 8-[4-[4-(2-pyrimidinyl)-1-pipirazinyl]butyl]-8-azaspiro[4,5]decane-7,9-dione Hydrochloride

120. 8-[4-[4-(pyrimidine-2-yl)-piperazine-1-yl]-butyl]-8-aza-spiro[4.5]decane-7,9-dione Hydrochloride

121. 8-azaspiro[4.5]decane-7,9-dione, 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-, Hydrochloride (1:1)

122. Buspirone Hcl Pound>>mj 9022 1 Pound>> Mj-9022-1 Pound>>mj90221 Pound>>mj9022 1 Pound>>mj9022-1

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

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 422.0 g/mol
Molecular Formula C21H32ClN5O2
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count6
Rotatable Bond Count6
Exact Mass421.2244530 g/mol
Monoisotopic Mass421.2244530 g/mol
Topological Polar Surface Area69.6 Ų
Heavy Atom Count29
Formal Charge0
Complexity529
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 2  
Drug NameBuspirone hydrochloride
Drug LabelBuspirone hydrochloride tablets USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs.Buspirone hydrochloride is a white crystalline, water soluble co...
Active IngredientBuspirone hydrochloride
Dosage FormTablet
RouteOral
Strength5mg; 7.5mg; 30mg; 10mg; 15mg
Market StatusPrescription
CompanyWatson Labs; Teva; Zydus Pharms Usa; Strides Arcolab; Dr Reddys Labs; Prosam Labs; Mylan

2 of 2  
Drug NameBuspirone hydrochloride
Drug LabelBuspirone hydrochloride tablets USP are an antianxiety agent that is not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs.Buspirone hydrochloride is a white crystalline, water soluble co...
Active IngredientBuspirone hydrochloride
Dosage FormTablet
RouteOral
Strength5mg; 7.5mg; 30mg; 10mg; 15mg
Market StatusPrescription
CompanyWatson Labs; Teva; Zydus Pharms Usa; Strides Arcolab; Dr Reddys Labs; Prosam Labs; Mylan

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Anti-Anxiety Agents

Agents that alleviate ANXIETY, tension, and ANXIETY DISORDERS, promote sedation, and have a calming effect without affecting clarity of consciousness or neurologic conditions. ADRENERGIC BETA-ANTAGONISTS are commonly used in the symptomatic treatment of anxiety but are not included here. (See all compounds classified as Anti-Anxiety Agents.)


Serotonin Receptor Agonists

Endogenous compounds and drugs that bind to and activate SEROTONIN RECEPTORS. Many serotonin receptor agonists are used as ANTIDEPRESSANTS; ANXIOLYTICS; and in the treatment of MIGRAINE DISORDERS. (See all compounds classified as Serotonin Receptor Agonists.)


API Reference Price

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RESEARCH","customerCountry":"INDIA","quantity":"217.00","actualQuantity":"217","unit":"KGS","unitRateFc":"550","totalValueFC":"120754.2","currency":"USD","unitRateINR":"46172.5","date":"09-Feb-2024","totalValueINR":"10019432.5","totalValueInUsd":"120754.2","indian_port":"Bombay Air","hs_no":"29335990","bill_no":"2076614","productDescription":"API","marketType":"REGULATED MARKET","country":"FINLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"HELSINKI","supplierAddress":"KOIVU-MANKKAAN TIE 6 AP.O.BOX 28 FI-02101 ESPOOFINLAND FI","customerAddress":"221, GOREGAON-MULUND LINK ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1710959400,"product":"BUSPIRONE HYDROCHLORIDE SIEVED BATCH: 2313104","address":"206, DEVAVRATA,","city":"NAVI MUMBAI, MAHARASHTRA.","supplier":"FAREVA","supplierCountry":"GERMANY","foreign_port":"N|RNBERG (NUREMBERG)","customer":"STRIDES PHARMA SCIENCE","customerCountry":"INDIA","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"374","totalValueFC":"229324.3","currency":"EUR","unitRateINR":"38084.3","date":"21-Mar-2024","totalValueINR":"19042125","totalValueInUsd":"229324.3","indian_port":"Bangalore Air","hs_no":"29335990","bill_no":"2684936","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"N|RNBERG (NUREMBERG)","supplierAddress":"POSTFACH 1330D-90533FEUCHT GERMANY","customerAddress":"206, DEVAVRATA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1710959400,"product":"BUSPIRONE HYDROCHLORIDE SIEVED BATCH:2313104","address":"206, DEVAVRATA,","city":"NAVI MUMBAI, MAHARASHTRA.","supplier":"FAREVA","supplierCountry":"GERMANY","foreign_port":"N|RNBERG (NUREMBERG)","customer":"STRIDES PHARMA SCIENCE","customerCountry":"INDIA","quantity":"48.00","actualQuantity":"48","unit":"KGS","unitRateFc":"374","totalValueFC":"22015.1","currency":"EUR","unitRateINR":"38084.3","date":"21-Mar-2024","totalValueINR":"1828044","totalValueInUsd":"22015.1","indian_port":"Bangalore Air","hs_no":"29335990","bill_no":"2684936","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"N|RNBERG (NUREMBERG)","supplierAddress":"POSTFACH 1330D-90533FEUCHT GERMANY","customerAddress":"206, DEVAVRATA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1711045800,"product":"9089100 - BUSPIRONE HYDROCHLORIDE SIEVED","address":"8-2120\/86\/9\/A\/1,12 & 2\/13,ANILATH,","city":"BANJARA HILLS,TELANGANA","supplier":"EXCELLA GMBH","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"STRIDES PHARMA SCIENCE","customerCountry":"INDIA","quantity":"773.38","actualQuantity":"773.38","unit":"KGS","unitRateFc":"374","totalValueFC":"354709.7","currency":"EUR","unitRateINR":"38084.3","date":"22-Mar-2024","totalValueINR":"29453597.63","totalValueInUsd":"354709.7","indian_port":"Bangalore Air","hs_no":"29335990","bill_no":"2693939","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"NUERNBERGER STR 12 90837 FEUCHT Frankfurt am Main, , GERMANYSDNF GERMANY","customerAddress":"8-2120\/86\/9\/A\/1,12 & 2\/13,ANILATH,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1713897000,"product":"BUSPIRONE HYDROCHLORIDE","address":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"FERMION OY","supplierCountry":"FINLAND","foreign_port":"HELSINKI (HELSINGFORS)","customer":"APL HEALTHCARE","customerCountry":"INDIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"550","totalValueFC":"111175.9","currency":"USD","unitRateINR":"46420","date":"24-Apr-2024","totalValueINR":"9284000","totalValueInUsd":"111175.9","indian_port":"APIIC MULTI PRODUCT SEZ NAIDUPET AP","hs_no":"29335990","bill_no":"1000572","productDescription":"API","marketType":"REGULATED MARKET","country":"FINLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"HELSINKI (HELSINGFORS)","supplierAddress":"KOIVU - MANKKAAN TIE 6 A, P.O.BOX 28 FI - 02101 ESPOO, FI","customerAddress":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1715711400,"product":"9089100 BUSPIRONE HYDROCHLORIDE SIEVED","address":"8-2120\/86\/9\/A\/1,12 & 2\/13,ANILATH,","city":"BANJARA HILLS,TELANGANA","supplier":"FAREVA","supplierCountry":"GERMANY","foreign_port":"DUESSELDORF","customer":"STRIDES PHARMA SCIENCE","customerCountry":"INDIA","quantity":"226.70","actualQuantity":"226.7","unit":"KGS","unitRateFc":"374","totalValueFC":"103578.5","currency":"EUR","unitRateINR":"38084.3","date":"15-May-2024","totalValueINR":"8633699.48","totalValueInUsd":"103578.5","indian_port":"Bangalore Air","hs_no":"29335990","bill_no":"3499884","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"DUESSELDORF","supplierAddress":"POSTFACH 1330, NRNBERGER STR. 12,D-90533,D-90537, FEUCHT, GERMANY","customerAddress":"8-2120\/86\/9\/A\/1,12 & 2\/13,ANILATH,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724178600,"product":"9089100 BUSPIRONE HYDROCHLORIDE SIEVED","address":"206, DEVAVRATA,","city":"NAVI MUMBAI, MAHARASHTRA.","supplier":"KLOUS AND KOUPLER LLC-FZ","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"STRIDES PHARMA 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SCIENCE","customerCountry":"INDIA","quantity":"1040.00","actualQuantity":"1040","unit":"KGS","unitRateFc":"425","totalValueFC":"475583.2","currency":"EUR","unitRateINR":"38590","date":"27-Nov-2024","totalValueINR":"40133600","totalValueInUsd":"475583.2","indian_port":"Madras Air","hs_no":"29335990","bill_no":"6913987","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"DUESSELDORF","supplierAddress":"THE MEYDAN HOTEL,GRANDSTAND, 6TH FLOOR MEYDAN ROAD, 12345 , NAD AL SHEBA, DUBAI, UNITED ARAB EMIRATES","customerAddress":"8-2120\/86\/9\/A\/1,12 & 2\/13,ANILATH,"}]
01-Feb-2021
27-Nov-2024
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ABOUT THIS PAGE

Buspirone Hydrochloride Manufacturers

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

Buspirone Hydrochloride Suppliers

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

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

Buspirone Hydrochloride USDMF

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

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

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

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

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

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

Buspirone Hydrochloride CEP

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

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

Buspirone Hydrochloride WC

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

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

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

Finished drug products

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

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

Buspirone Hydrochloride GMP

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

Buspirone Hydrochloride CoA

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

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

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