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Chemistry

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Also known as: 64-75-5, Tetracycline hcl, Achromycin hydrochloride, Bristacycline, Sustamycin, Tetracycline.hcl
Molecular Formula
C22H25ClN2O8
Molecular Weight
480.9  g/mol
InChI Key
YCIHPQHVWDULOY-FMZCEJRJSA-N
FDA UNII
P6R62377KV

Tetracycline Hydrochloride
A naphthacene antibiotic that inhibits AMINO ACYL TRNA binding during protein synthesis.
1 2D Structure

Tetracycline Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(4S,4aS,5aS,6S,12aR)-4-(dimethylamino)-1,6,10,11,12a-pentahydroxy-6-methyl-3,12-dioxo-4,4a,5,5a-tetrahydrotetracene-2-carboxamide;hydrochloride
2.1.2 InChI
InChI=1S/C22H24N2O8.ClH/c1-21(31)8-5-4-6-11(25)12(8)16(26)13-9(21)7-10-15(24(2)3)17(27)14(20(23)30)19(29)22(10,32)18(13)28;/h4-6,9-10,15,25-26,29,31-32H,7H2,1-3H3,(H2,23,30);1H/t9-,10-,15-,21+,22-;/m0./s1
2.1.3 InChI Key
YCIHPQHVWDULOY-FMZCEJRJSA-N
2.1.4 Canonical SMILES
CC1(C2CC3C(C(=O)C(=C(C3(C(=O)C2=C(C4=C1C=CC=C4O)O)O)O)C(=O)N)N(C)C)O.Cl
2.1.5 Isomeric SMILES
C[C@@]1([C@H]2C[C@H]3[C@@H](C(=O)C(=C([C@]3(C(=O)C2=C(C4=C1C=CC=C4O)O)O)O)C(=O)N)N(C)C)O.Cl
2.2 Other Identifiers
2.2.1 UNII
P6R62377KV
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 4 Epitetracycline

2. 4-epitetracycline

3. Achromycin

4. Achromycin V

5. Hostacyclin

6. Sustamycin

7. Tetrabid

8. Tetracycline

9. Tetracycline Monohydrochloride

10. Topicycline

2.3.2 Depositor-Supplied Synonyms

1. 64-75-5

2. Tetracycline Hcl

3. Achromycin Hydrochloride

4. Bristacycline

5. Sustamycin

6. Tetracycline.hcl

7. Cyclopar

8. Sumycin

9. Tetracycline (hydrochloride)

10. Achromycin V

11. Neocycline B

12. Vetquamycin 324

13. Achromycin

14. Supramycin

15. Telotrex

16. Nci-c55561

17. Nsc-757338

18. Quatrex

19. P6r62377kv

20. Dumocyclin

21. (4s,4as,5as,6s,12as)-4-(dimethylamino)-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide Hydrochloride

22. 64-75-5 (hcl)

23. Dsstox_cid_1321

24. Dsstox_rid_76081

25. Dsstox_gsid_21321

26. (4s,4as,5as,6s,12as)-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide Monohydrochloride

27. Hostacycline

28. Mephacyclin

29. Quadracycline

30. Remicyclin

31. Stilciclina

32. Tetrabakat

33. Tetracompren

34. Tetralution

35. Tetramavan

36. Topicycline

37. Triphacyclin

38. Actisite

39. Artomycin

40. Diacycine

41. Partrex

42. Piracaps

43. Ricycline

44. Subamycin

45. Tefilin

46. Tetrabid

47. Tetrablet

48. Tetracaps

49. Tetrakap

50. Tetramed

51. Tetrosol

52. Paltet

53. Qidtet

54. Retet

55. Teline

56. Unicin

57. Tetra-wedel

58. Neocyclin B

59. Ro-cycline

60. Polyotic Ointment

61. Tetrasure

62. Tet-cy

63. Tetra-d

64. Vetquamycin-324

65. Cancycline-250

66. (4s,4as,5as,6s,12ar)-4-(dimethylamino)-1,6,10,11,12a-pentahydroxy-6-methyl-3,12-dioxo-4,4a,5,5a-tetrahydrotetracene-2-carboxamide;hydrochloride

67. 2-naphthacenecarboxamide,4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, Monohydrochloride,(4s,4as,5as,6s,12as)-

68. Cefracycline Tablets

69. Tetracycline Chloride

70. Panmycin Hydrochloride

71. Sentry Av Ornacycline

72. T-250 Capsules

73. Tetracyn Hydrochloride

74. Tetraciclina Cloridrato

75. Ala Tet

76. Polycycline Hydrochloride

77. Chlorowodorku Tetracykliny

78. Mfcd00078142

79. Chlorhydrate De Tetracycline

80. Unii-p6r62377kv

81. Ccris 2351

82. Sr-01000000212

83. Sr-05000001723

84. (-)-tetrahcycline Hydrochloride

85. Tetracycline Hydrochloride [jan]

86. Tetraciclina Cloridrato [italian]

87. Chlorowodorku Tetracykliny [polish]

88. (4s,4as,5as,6s,12as)-4-(dimethylamino)-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-4,4a,5,5a-tetrahydrotetracene-2-carboxamide;hydrochloride

89. Prestwick_434

90. Einecs 200-593-8

91. Bristacycline (tn)

92. Chlorhydrate De Tetracycline [french]

93. Tetracycline Hydrochloride [usp:jan]

94. Tetracycline Hydrochloride (internal Use)

95. Ai3-50120

96. Cas-64-75-5

97. Ncgc00016291-01

98. Tetracyclini Hydrochloridum

99. Ec 200-593-8

100. U-5965

101. Schembl34248

102. Spectrum1500566

103. Chembl454950

104. Dtxsid6021321

105. Nci-c55561;tetracycline Hcl

106. Tetracycline Hydrochloride, Powder

107. Hms1568k22

108. Hms1921c19

109. Pharmakon1600-01500566

110. Hy-b0474

111. Tox21_110355

112. Tox21_200516

113. Ccg-39267

114. Nsc757338

115. S2574

116. Akos015951263

117. Tox21_110355_1

118. Bcp9000227

119. Ks-1431

120. Nsc 757338

121. Tetracycline Hydrochloride (jp17/usp)

122. Tetracycline Hydrochloride [mi]

123. Ncgc00017323-08

124. Ncgc00180907-01

125. Ncgc00180907-02

126. Ncgc00258070-01

127. (4s,6s,12as,4as,5as)-4-(dimethylamino)-3,6,10,12,12a-pentahydroxy-6-methyl-1,1 1-dioxo-4,5,6,12a,4a,5a-hexahydronaphthacene-2-carboxamide, Chloride

128. 2-naphthacenecarboxamide, 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, Monohydrochloride, (4s,4as,5as,6s,12as)-

129. 2-naphthacenecarboxamide, 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, Monohydrochloride, (4s-(4alpha,4aalpha,5aalpha,6beta,12aalpha))-

130. Tetracycline Hydrochloride [mart.]

131. Tetracycline Hydrochloride [vandf]

132. Bcp0726000161

133. Tetracycline Hydrochloride [usp-rs]

134. Tetracycline Hydrochloride [who-dd]

135. Tetracycline Hydrochloride [who-ip]

136. Sw196293-4

137. D02122

138. D92606

139. Tetracycline Hydrochloride [green Book]

140. Tetracycline Hydrochloride [orange Book]

141. Tetracycline Hydrochloride [ep Monograph]

142. Apt T3x Component Tetracycline Tetracycline

143. Apt-t3x Component Tetracycline Tetracycline

144. Helidac Component Tetracycline Hydrochloride

145. Tetracycline Hydrochloride [usp Monograph]

146. Tetracyclini Hydrochloridum [who-ip Latin]

147. Sr-01000000212-4

148. Sr-05000001723-2

149. Q27286287

150. Tetracycline Hydrochloride 1000 Microg/ml In Ethanol

151. Tetracycline Hydrochloride Component Of Helidac

152. Tetracycline Tetracycline Component Of Apt T3x

153. Tetracycline Hydrochloride 100 Microg/ml In Acetonitrile

154. Tetracycline Hydrochloride, Meets Usp Testing Specifications

155. Tetracycline Hydrochloride, Vetranal(tm), Analytical Standard

156. Tetracycline Hydrochloride, >=95% (european Pharmacopoeia Hplc Assay)

157. Tetracycline Hydrochloride, British Pharmacopoeia (bp) Reference Standard

158. Tetracycline Hydrochloride, European Pharmacopoeia (ep) Reference Standard

159. Tetracycline Hydrochloride, Powder, Bioreagent, Suitable For Cell Culture

160. Tetracycline Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

161. Tetracycline Hydrochloride, United States Pharmacopeia (usp) Reference Standard

162. (4s,4as,5as,6s,12ar)-4-(dimethylamino)-1,6,10,11,12a-pentahydroxy-6-methyl-3,12-dioxo-3,4,4a,5,5a,6,12,12a-octahydrotetracene-2-carboxamide Hydrochloride

163. (4s,4as,5as,6s,12as)-4-(dimethylamino)-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamidehydrochloride

164. (4s,4as,5as,6s,12as)-4-(dimethylamino)-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-4,4a,5,5a-tetrahydrotetracene-2-carboxamide Hydrochloride

165. (4s,4as,5as,6s,12as,z)-2-(amino(hydroxy)methylene)-4-(dimethylamino)-6,10,11,12a-tetrahydroxy-6-methyl-4a,5a,6,12a-tetrahydrotetracene-1,3,12(2h,4h,5h)-trione Hydrochloride

166. 2-naphthacenecarboxamide, 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, Hydrochloride (1:1), (4s,4as,5as,6s,12as)-

167. 2-naphthacenecarboxamide, 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, Monohydrochloride, (4s-(4.alpha.,4a.alpha.,5a.alpha.,6.beta.,12a.alpha.))-

168. 2-naphthacenecarboxamide, 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, Monohydrochloride, (4s-(4alpha,4aalpha,5aalpha,6beta,12alpha))-

2.4 Create Date
2011-12-26
3 Chemical and Physical Properties
Molecular Weight 480.9 g/mol
Molecular Formula C22H25ClN2O8
Hydrogen Bond Donor Count7
Hydrogen Bond Acceptor Count9
Rotatable Bond Count2
Exact Mass480.1299435 g/mol
Monoisotopic Mass480.1299435 g/mol
Topological Polar Surface Area182 Ų
Heavy Atom Count33
Formal Charge0
Complexity971
Isotope Atom Count0
Defined Atom Stereocenter Count5
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 NameTetracycline hydrochloride
Drug LabelTetracycline is a yellow, odorless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetr...
Active IngredientTetracycline hydrochloride
Dosage FormCapsule
RouteOral
Strength250mg; 500mg; 100mg
Market StatusPrescription
CompanyWatson Labs; Ivax Sub Teva Pharms; Impax Labs

2 of 2  
Drug NameTetracycline hydrochloride
Drug LabelTetracycline is a yellow, odorless, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions. Tetr...
Active IngredientTetracycline hydrochloride
Dosage FormCapsule
RouteOral
Strength250mg; 500mg; 100mg
Market StatusPrescription
CompanyWatson Labs; Ivax Sub Teva Pharms; Impax Labs

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Anti-Bacterial Agents

Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)


Protein Synthesis Inhibitors

Compounds which inhibit the synthesis of proteins. They are usually ANTI-BACTERIAL AGENTS or toxins. Mechanism of the action of inhibition includes the interruption of peptide-chain elongation, the blocking the A site of ribosomes, the misreading of the genetic code or the prevention of the attachment of oligosaccharide side chains to glycoproteins. (See all compounds classified as Protein Synthesis Inhibitors.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Tetracyclines [CS]; Tetracycline-class Antimicrobial [EPC]

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ZHANGJIAGANG CITY, JIANGSU, CHINA","customerAddress":"213, LAXMI PLAZA, LAXMI INDL."},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730658600,"product":"OXYTETRACYCLINE HYDROCHLORIDE IP (200 DRM)(LONGCHEM INTERNATIONAL TRADING COMPANY LIMITED) IUPAC NAME: (4S,4AR,5S,5AR,6SOXYTETRACYCLINE HYDROCHLORIDE IP (200 DRM)(LONGCHEM INTERNAT","address":"DARABSHAW HOUSE LEVEL 1 SHOORJI","city":"MUMBAI","supplier":"SHANGHAI FINE CHEMICALS CO.,LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"NHAVA SHEVA BUSINESS PARK PRIVATE LIMITED","customerCountry":"INDIA","quantity":"5000.00","actualQuantity":"5000","unit":"KGS","unitRateFc":"10.5","totalValueFC":"52849.5","currency":"USD","unitRateINR":"892","date":"04-Nov-2024","totalValueINR":"4459875","totalValueInUsd":"52849.5","indian_port":"JNPT SEZ\/MUMBAI","hs_no":"29413020","bill_no":"6477525","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"RM719, NO.8-9, MAX-MALL, LANE 1500 SOUTH LIANHUA ROAD, SHANGHAI Shangh ai, , CHINA CHINA","customerAddress":"DARABSHAW HOUSE LEVEL 1 SHOORJI"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731349800,"product":"OXYTETRACYCLINE HYDROCHLORIDE IP","address":"48, CHANDRA GUPTA ESTATE,","city":"MUMBAI, MAHARASHTRA.","supplier":"HEBEI HONGCHENG YAXIN TECHNOLOGY CO LTD","supplierCountry":"CHINA","foreign_port":"TIANJIN","customer":"GORANG INTERNATIONAL","customerCountry":"INDIA","quantity":"10000.00","actualQuantity":"10000","unit":"KGS","unitRateFc":"12.3","totalValueFC":"149371.1","currency":"USD","unitRateINR":"1260.5","date":"12-Nov-2024","totalValueINR":"12605152.56","totalValueInUsd":"149371.1","indian_port":"Bombay Air","hs_no":"29413020","bill_no":"6633415","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"TIANJIN","supplierAddress":"NO. 50 SHENGXUE ROAD LUANCHENG SHIJ IAZHUANG 051430 HEBEI CHINA SDNF China","customerAddress":"48, CHANDRA GUPTA ESTATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731349800,"product":"TETRACYCLINE HYDROCHLORIDE (CAS: 64-75-5) TETRACYCLINE HYDROCHLORIDE (CAS: 64-75-5)","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"CBC (CHANGCHUN) PHARMACEUTICAL CO., LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"101.3","totalValueFC":"20454.9","currency":"USD","unitRateINR":"8630.8","date":"12-Nov-2024","totalValueINR":"1726152","totalValueInUsd":"20454.9","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29413090","bill_no":"6633412","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"ROOM 17163 , 17164 AND 17137 , 1 - (BUILDING), BLOCK B, WANDA PLAZA THE CROSS OF KAIXUAN ROAD AND TAIBE CN","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731436200,"product":"OXYTETRACYCLINE HYDROCHLORIDE IP (200 DRM)(LONGCHEM INTERNATIONAL TRADING COMPANY LIMITED) IUPAC NAME: (4S,4AR,5S,5AR,6SOXYTETRACYCLINE HYDROCHLORIDE IP (200 DRM)(LONGCHEM INTERNAT","address":"305 AGGARWAL CITY SQUARE","city":"DELHI","supplier":"LONGCHEM INTERNATIONALTRADING COMPANY LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"SHAH TC DISTRIBUTION LLP","customerCountry":"INDIA","quantity":"4000.00","actualQuantity":"4000","unit":"KGS","unitRateFc":"10.5","totalValueFC":"42404","currency":"USD","unitRateINR":"894.6","date":"13-Nov-2024","totalValueINR":"3578400","totalValueInUsd":"42404","indian_port":"JNPT SEZ\/MUMBAI","hs_no":"29413020","bill_no":"6655540","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"UNIT 2 OF LG 1, MIRROR TOWER, 61 MO DY ROAD, TSIM SHA TSUI, KOWLOON HON G KONG Kowloon, , HONG KONG HONG KONG","customerAddress":"305 AGGARWAL CITY SQUARE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732213800,"product":"TETRACYCLINE HYDROCHLORIDE IP","address":"PLOT NO 10-A, GIDC ESTATE,","city":"MAHESANA","supplier":"SINOBRIGHT PHARMACEUTICAL COMPANY LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"RISHABH LIFESCIENCE PRIVATE ","customerCountry":"INDIA","quantity":"2000.00","actualQuantity":"2000","unit":"KGS","unitRateFc":"20.8","totalValueFC":"42191.6","currency":"USD","unitRateINR":"1780.2","date":"22-Nov-2024","totalValueINR":"3560475.01","totalValueInUsd":"42191.6","indian_port":"JNPT","hs_no":"29413020","bill_no":"6812728","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"S LIMITED OFFICE F, 32\/F , PLAZA 88 NO.88 YEUNG UK ROAD, TSUEN WAN, NT, HONG KONG, CHINA","customerAddress":"PLOT NO 10-A, GIDC ESTATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732905000,"product":"TETRACYCLINE HYDROCHLORIDE BP\/USP (TETRACYCLINE HYDROCHLORIDE)","address":"25, 2ND PULIYUR MAIN ROAD,","city":"CHENNAI, TAMILNADU","supplier":"ZHEJIANG UEASY BUSINESS ","supplierCountry":"CHINA","foreign_port":"N\/A","customer":"MEDOPHARM PRIVATE LIMITED","customerCountry":"INDIA","quantity":"750.00","actualQuantity":"750","unit":"KGS","unitRateFc":"22","totalValueFC":"16688.1","currency":"USD","unitRateINR":"1877.7","date":"30-Nov-2024","totalValueINR":"1408275","totalValueInUsd":"16688.1","indian_port":"Madras Sea","hs_no":"29413020","bill_no":"6972204","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"NO 22 GREAT WALL STREET XIACHENG DI STRICT HANGZHOU China","customerAddress":"25, 2ND PULIYUR MAIN ROAD,"}]
05-Jan-2021
30-Nov-2024
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Quantity (KGS) & Unit rate (USD/KGS) over time

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - CAPSULE;ORAL - 250MG

USFDA APPLICATION NUMBER - 50278

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DOSAGE - CAPSULE;ORAL - 500MG

USFDA APPLICATION NUMBER - 50278

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ABOUT THIS PAGE

CAS-64-75-5 Manufacturers

A CAS-64-75-5 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CAS-64-75-5, including repackagers and relabelers. The FDA regulates CAS-64-75-5 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CAS-64-75-5 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 CAS-64-75-5 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

CAS-64-75-5 Suppliers

A CAS-64-75-5 supplier is an individual or a company that provides CAS-64-75-5 active pharmaceutical ingredient (API) or CAS-64-75-5 finished formulations upon request. The CAS-64-75-5 suppliers may include CAS-64-75-5 API manufacturers, exporters, distributors and traders.

click here to find a list of CAS-64-75-5 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

CAS-64-75-5 USDMF

A CAS-64-75-5 DMF (Drug Master File) is a document detailing the whole manufacturing process of CAS-64-75-5 active pharmaceutical ingredient (API) in detail. Different forms of CAS-64-75-5 DMFs exist exist since differing nations have different regulations, such as CAS-64-75-5 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A CAS-64-75-5 DMF submitted to regulatory agencies in the US is known as a USDMF. CAS-64-75-5 USDMF includes data on CAS-64-75-5's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CAS-64-75-5 USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of CAS-64-75-5 suppliers with USDMF on PharmaCompass.

CAS-64-75-5 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 CAS-64-75-5 Drug Master File in Japan (CAS-64-75-5 JDMF) empowers CAS-64-75-5 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 CAS-64-75-5 JDMF during the approval evaluation for pharmaceutical products. At the time of CAS-64-75-5 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 CAS-64-75-5 suppliers with JDMF on PharmaCompass.

CAS-64-75-5 CEP

A CAS-64-75-5 CEP of the European Pharmacopoeia monograph is often referred to as a CAS-64-75-5 Certificate of Suitability (COS). The purpose of a CAS-64-75-5 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of CAS-64-75-5 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of CAS-64-75-5 to their clients by showing that a CAS-64-75-5 CEP has been issued for it. The manufacturer submits a CAS-64-75-5 CEP (COS) as part of the market authorization procedure, and it takes on the role of a CAS-64-75-5 CEP holder for the record. Additionally, the data presented in the CAS-64-75-5 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the CAS-64-75-5 DMF.

A CAS-64-75-5 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. CAS-64-75-5 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 CAS-64-75-5 suppliers with CEP (COS) on PharmaCompass.

CAS-64-75-5 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 CAS-64-75-5 as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for CAS-64-75-5 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 CAS-64-75-5 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 CAS-64-75-5 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a CAS-64-75-5 NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of CAS-64-75-5 suppliers with NDC on PharmaCompass.

CAS-64-75-5 GMP

CAS-64-75-5 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 CAS-64-75-5 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 CAS-64-75-5 GMP manufacturer or CAS-64-75-5 GMP API supplier for your needs.

CAS-64-75-5 CoA

A CAS-64-75-5 CoA (Certificate of Analysis) is a formal document that attests to CAS-64-75-5's compliance with CAS-64-75-5 specifications and serves as a tool for batch-level quality control.

CAS-64-75-5 CoA mostly includes findings from lab analyses of a specific batch. For each CAS-64-75-5 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.

CAS-64-75-5 may be tested according to a variety of international standards, such as European Pharmacopoeia (CAS-64-75-5 EP), CAS-64-75-5 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (CAS-64-75-5 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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