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Chemistry

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Also known as: 2058-46-0, Oxytetracycline hcl, Terramycin hydrochloride, Oxytetracycline.hcl, Bisolvomycin, Terramycin
Molecular Formula
C22H25ClN2O9
Molecular Weight
496.9  g/mol
InChI Key
SVDOODSCHVSYEK-IFLJXUKPSA-N
FDA UNII
4U7K4N52ZM

Oxytetracycline Hydrochloride
A TETRACYCLINE analog isolated from the actinomycete STREPTOMYCES rimosus and used in a wide variety of clinical conditions.
1 2D Structure

Oxytetracycline Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(4S,4aR,5S,5aR,6S,12aR)-4-(dimethylamino)-1,5,6,10,11,12a-hexahydroxy-6-methyl-3,12-dioxo-4,4a,5,5a-tetrahydrotetracene-2-carboxamide;hydrochloride
2.1.2 InChI
InChI=1S/C22H24N2O9.ClH/c1-21(32)7-5-4-6-8(25)9(7)15(26)10-12(21)17(28)13-14(24(2)3)16(27)11(20(23)31)19(30)22(13,33)18(10)29;/h4-6,12-14,17,25-26,28,30,32-33H,1-3H3,(H2,23,31);1H/t12-,13-,14+,17+,21-,22+;/m1./s1
2.1.3 InChI Key
SVDOODSCHVSYEK-IFLJXUKPSA-N
2.1.4 Canonical SMILES
CC1(C2C(C3C(C(=O)C(=C(C3(C(=O)C2=C(C4=C1C=CC=C4O)O)O)O)C(=O)N)N(C)C)O)O.Cl
2.1.5 Isomeric SMILES
C[C@@]1([C@H]2[C@@H]([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)O.Cl
2.2 Other Identifiers
2.2.1 UNII
4U7K4N52ZM
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Bisolvomycin

2. Geomycin

3. Hydroxytetracycline

4. Oxyterracin

5. Oxyterracine

6. Oxytetracid

7. Oxytetracycline

8. Oxytetracycline Anhydrous

9. Oxytetracycline Calcium

10. Oxytetracycline Dihydrate

11. Oxytetracycline Monohydrochloride

12. Oxytetracycline Sulfate (2:1)

13. Oxytetracycline, (4a Beta,5 Beta,5a Beta,12a Beta)-isomer

14. Oxytetracycline, (5 Beta)-isomer

15. Oxytetracycline, Anhydrous

16. Oxytetracycline, Calcium (1:1) Salt

17. Oxytetracycline, Disodium Salt, Dihydrate

18. Oxytetracycline, Sodium Salt

19. Terramycin

2.3.2 Depositor-Supplied Synonyms

1. 2058-46-0

2. Oxytetracycline Hcl

3. Terramycin Hydrochloride

4. Oxytetracycline.hcl

5. Bisolvomycin

6. Terramycin

7. Dalimycin

8. Unimycin

9. Oxy-kesso-tetra

10. Alamycin

11. Imperacin

12. Mepatar

13. Oxacycline

14. Oxymykoin

15. Oxysteclin

16. Vendarcin

17. Oxytetracyclini Hydrochloridum

18. Dalinmycin

19. Engemycin

20. Oxamycen

21. Liquamycin Injectable

22. Aquacycline

23. Hydrocyclin

24. Oxybiocycline

25. Abbocin

26. Chrysocin

27. Elinton

28. Intaloxin

29. Liquachel

30. Macodyn

31. Otetryn

32. Oxlopar

33. Oxycycline

34. Oxyject

35. Oxytetral

36. Oxytetrin

37. Oxytracyl

38. Terraject

39. Toxinal

40. Biotet

41. Oxyvet

42. Oxy-dumocyclin

43. Tetra-tablinen

44. Oxy-terachel

45. Bi Steclin

46. Ia-loxin

47. Oxy-rivo

48. Uri-tet

49. Tetran Hydrochloride

50. 5-hydroxytetracycline Hydrochloride

51. Stecsolin

52. Oxydon

53. Tm 5

54. Oxy-tet 50

55. Tetracycline, 5-oxy-

56. Oxy-ws

57. Oxytetracycline (hydrochloride)

58. 4u7k4n52zm

59. Nsc 9169

60. Biosolvomycin

61. Chebi:31953

62. Oxy-de 250

63. 5-hydroxytetracycline Monohydrochloride

64. 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,6,10,12,12a-hexahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide Monohydrochloride

65. Ncgc00091268-01

66. Oxytet

67. Terramycin (tn)

68. Dsstox_cid_1097

69. Component Of Terramycin Topical Ointment

70. Dsstox_rid_75939

71. Dsstox_gsid_21097

72. (4s,4ar,5s,5ar,6s,12ar)-4-(dimethylamino)-1,5,6,10,11,12a-hexahydroxy-6-methyl-3,12-dioxo-4,4a,5,5a-tetrahydrotetracene-2-carboxamide;hydrochloride

73. Oxy Ws

74. Oxyject 100

75. Caswell No. 628

76. Oxytetracycline Hydrochloride 100 Microg/ml In Acetonitrile

77. Oxatet

78. Hydroxytetrazyklinhydrochlorid

79. Ccris 200

80. Cas-2058-46-0

81. Tm 5 (van)

82. Nsc-757262

83. (4s,4ar,5s,5ar,6s,12as)-4-(dimethylamino)-3,5,6,10,12,12a-hexahydroxy-6-methyl-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide Hydrochloride

84. Einecs 218-161-2

85. Epa Pesticide Chemical Code 006308

86. Unii-4u7k4n52zm

87. Neo-oxy 100/100 Mr

88. Ai3-50164

89. Oxytetracycline Hydrochloride (internal Use)

90. (4s,4ar,5s,5ar,6s,12as)-4-(dimethylamino)-3,5,6,10,12,12a-hexahydroxy-6-methyl-1,11-dioxo-4,4a,5,5a-tetrahydrotetracene-2-carboxamide;hydrochloride

91. Oxytetracycline Hydrochloride [jan]

92. Oxytetracycline Hydrochloride [usp:jan]

93. 2-naphthacenecarboxamide, 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,6,10,12,12a-hexahydroxy-6-methyl-1,11-dioxo-, Monohydrochloride, (4s,4ar,5s,5ar,6s,12as)-

94. 2-naphthacenecarboxamide, 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,6,10,12,12a-hexahydroxy-6-methyl-1,11-dioxo-, Monohydrochloride, (4s-(4alpha,4aalpha,5alpha,5aalpha,6beta,12aalpha))-

95. Schembl124996

96. Spectrum1500457

97. Chembl1607480

98. Chembl4549546

99. Chembl4591469

100. Dtxsid5021097

101. Hy-b0275a

102. Hms1920f04

103. Pharmakon1600-01500457

104. Tox21_111109

105. Tox21_201850

106. Tox21_300601

107. Ccg-40206

108. Mfcd00135815

109. Nsc757262

110. S5199

111. Oxytetracycline For System Suitability

112. Akos015950811

113. Nc00526

114. Ncgc00164443-01

115. Ncgc00254367-01

116. Ncgc00259399-01

117. (4s,5s,6s,12as,4ar,5ar)-4-(dimethylamino)-3,5,6,10,12,12a-hexahydroxy-6-methyl -1,11-dioxo-4,5,6,12a,4a,5a-hexahydronaphthacene-2-carboxamide, Chloride

118. Ac-11614

119. Oxytetracycline Hydrochloride (jp17/usp)

120. Oxytetracycline Hydrochloride [mi]

121. Cs-0013151

122. O0475

123. Oxytetracycline Hydrochloride [mart.]

124. Oxytetracycline Hydrochloride [vandf]

125. Oxytetracycline Hydrochloride [usp-rs]

126. Oxytetracycline Hydrochloride [who-dd]

127. Oxytetracycline Hydrochloride [who-ip]

128. D01596

129. Oxytetracycline Hydrochloride [green Book]

130. Oxytetracycline Hydrochloride [orange Book]

131. Oxytetracycline Hydrochloride [ep Monograph]

132. Oxytetracycline Hydrochloride [usp Monograph]

133. Oxytetracyclini Hydrochloridum [who-ip Latin]

134. Q27114732

135. Oxytetracycline Hydrochloride, >=95% (hplc), Crystalline

136. Terra-cortril Component Oxytetracycline Hydrochloride

137. Oxytetracycline Hydrochloride Component Of Terra-cortril

138. Oxytetracycline Hydrochloride, Vetranal(tm), Analytical Standard

139. Oxytetracycline Hydrochloride, European Pharmacopoeia (ep) Reference Standard

140. Oxytetracycline Hydrochloride, United States Pharmacopeia (usp) Reference Standard

141. 15000-39-2

142. 2-naphthacenecarboxamide, 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,6,10,12,12a-hexahydroxy-6-methyl-1,11-dioxo-, Hydrochloride (1:1), (4s,4ar,5s,5ar,6s,12as)-

143. 2-naphthacenecarboxamide, 4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,6,10,12,12a-hexahydroxy-6-methyl-1,11-dioxo-, Monohydrochloride, (4s-(4.alpha.,4a.alpha.,5.alpha.,5a.alpha.,6.beta.,12a.alpha.))-

144. Oxytetracycline Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

2.4 Create Date
2011-12-26
3 Chemical and Physical Properties
Molecular Weight 496.9 g/mol
Molecular Formula C22H25ClN2O9
Hydrogen Bond Donor Count8
Hydrogen Bond Acceptor Count10
Rotatable Bond Count2
Exact Mass496.1248581 g/mol
Monoisotopic Mass496.1248581 g/mol
Topological Polar Surface Area202 Ų
Heavy Atom Count34
Formal Charge0
Complexity1000
Isotope Atom Count0
Defined Atom Stereocenter Count6
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

Anti-Bacterial Agents

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


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ZHANGJIAGANG CITY, JIANGSU, CHINA","customerAddress":"213, LAXMI PLAZA, LAXMI INDL."},{"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":1734460200,"product":"OXYTETRACYCLINE HYDROCHLORIDE IP (400 DRM) IUPAC NAME: (4S,4 AR,5S,5AR,6S,12AR)-4-(DIMETHYLAMINO)-1,5,6,10,11,12A-HEXAHY","address":"304 AGGARWAL CITY SQUARE,MANGALAM","city":"DELHI,DELHI","supplier":"JIANGXI CHIBANG PHARMACEUTICAL CO.,LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"SHAH TC GLOBAL ","customerCountry":"INDIA","quantity":"10000.00","actualQuantity":"10000","unit":"KGS","unitRateFc":"11","totalValueFC":"110890","currency":"USD","unitRateINR":"942.2","date":"18-Dec-2024","totalValueINR":"9422207","totalValueInUsd":"110890","indian_port":"JNPT SEZ\/MUMBAI","hs_no":"29413020","bill_no":"7305421","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"N\/A","customerAddress":"304 AGGARWAL CITY SQUARE,MANGALAM"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734892200,"product":"OXYTETRACYCLINE HYDROCHLORIDE VET IP OXYTETRACYCLINE HYDROCHLORIDE IP","address":"13,VITHALDAS ROAD,BULAKHIDAS","city":"MUMBAI,MAHARASHTRA","supplier":"BRILLIANT PHARMACEUTICAL LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"MEDI PHARMA DRUG ","customerCountry":"INDIA","quantity":"5000.00","actualQuantity":"5000","unit":"KGS","unitRateFc":"10.6","totalValueFC":"53460.2","currency":"USD","unitRateINR":"908.5","date":"23-Dec-2024","totalValueINR":"4542457.5","totalValueInUsd":"53460.2","indian_port":"JNPT","hs_no":"29413020","bill_no":"7405940","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"6\/F MANULIFE PLACE 348 KWUN TONG RO AD KOWLOON HONG KONG SDNF CHINA","customerAddress":"13,VITHALDAS ROAD,BULAKHIDAS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734978600,"product":"OXYTETRACYCLINE HYDROCHLORIDE IP. OXYTETRACYCLINE HYDROCHLORIDE IP.","address":"48, CHANDRA GUPTA ESTATE,","city":"MUMBAI, MAHARASHTRA.","supplier":"HEBEI HONGCHENG YAXIN TECHNOLOGY CO LTD","supplierCountry":"CHINA","foreign_port":"XINGANG (CHINA)","customer":"GORANG INTERNATIONAL","customerCountry":"INDIA","quantity":"10000.00","actualQuantity":"10000","unit":"KGS","unitRateFc":"12.3","totalValueFC":"124622.4","currency":"USD","unitRateINR":"1058.9","date":"24-Dec-2024","totalValueINR":"10589040","totalValueInUsd":"124622.4","indian_port":"JNPT","hs_no":"29413020","bill_no":"7430658","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"XINGANG (CHINA)","supplierAddress":"NO. 50 SHENGXUE ROAD LUANCHENG SHIJ IAZHUANG HEBEI PROVINCE CHINA CHIN A, , China China","customerAddress":"48, CHANDRA GUPTA ESTATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1736447400,"product":"OXYTETRACYCLINE HYDROCHLORIDE IP (400 DRM)(LONGCHEM INTERNATIONAL TRADING COMPANY LIMITED) IUPAC NAME: (4S,4AR,5S,5AR,6SOXYTETRACYCLINE HYDROCHLORIDE IP (400 DRM)(LONGCHEM INTER","address":"DARABSHAW HOUSE LEVEL 1 SHOORJI","city":"MUMBAI","supplier":"ZHEJIANG XIHE IMPORT AND EXPORT CO., LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"NHAVA SHEVA BUSINESS PARK PRIVATE LIMITED","customerCountry":"INDIA","quantity":"10000.00","actualQuantity":"10000","unit":"KGS","unitRateFc":"10.9","totalValueFC":"108966.6","currency":"USD","unitRateINR":"939.6","date":"10-Jan-2025","totalValueINR":"9396100","totalValueInUsd":"108966.6","indian_port":"JNPT SEZ\/MUMBAI","hs_no":"29413020","bill_no":"7707600","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"ROOM 606, BUILDING 4, 188 ZIJINGHUA NORTH ROAD, WEST LAKE DISTRICT, HA NGZHOU ZHEJIANG PROVINCE Zhenjiang, CHINA","customerAddress":"DARABSHAW HOUSE LEVEL 1 SHOORJI"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1736965800,"product":"OXYTETRACYCLINE HYDROCHLORIDE VET IP OXYTETRACYCLINE HYDROCHLORIDE VET IP","address":"APEEJAY CHAMBER 1ST FLOOR","city":"MUMBAI ,MAHARASHTRA","supplier":"BRILLIANT PHARMACEUTICAL LIMITED.","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"KANTILAL MANILAL AND COMPANY PRIVATE LIMITED","customerCountry":"INDIA","quantity":"4000.00","actualQuantity":"4000","unit":"KGS","unitRateFc":"10.9","totalValueFC":"43649.5","currency":"USD","unitRateINR":"941","date":"16-Jan-2025","totalValueINR":"3763864","totalValueInUsd":"43649.5","indian_port":"JNPT","hs_no":"29413020","bill_no":"7823539","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"OFFICE F,32\/F,PLAZA 88 NO.88 YEUNG UK ROAD. TSUEN WAN, NT,HONG KONG,CH INA China","customerAddress":"APEEJAY CHAMBER 1ST FLOOR"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1738002600,"product":"OXYTETRACYCLINE HYDROCHLORIDE VET IP OXYTETRACYCLINE HYDROCHLORIDE VET IP","address":"501-502,AMBA SADAN,","city":"MUMBAI,MAHARASHTRA","supplier":"BRILLIANT PHARMACEUTICAL LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"GENERAL IMPORT COMPANY (INDIA) PRIVATE LIMITED","customerCountry":"INDIA","quantity":"3000.00","actualQuantity":"3000","unit":"KGS","unitRateFc":"10.4","totalValueFC":"31363.6","currency":"USD","unitRateINR":"901.5","date":"28-Jan-2025","totalValueINR":"2704455","totalValueInUsd":"31363.6","indian_port":"JNPT","hs_no":"29413020","bill_no":"8050991","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"OFFICE,F,32\/F, PLAZA 88NO.88 YEUNG UK ROAD, TSUEN WAN,NT, HONG KONG SDNF","customerAddress":"501-502,AMBA SADAN,"}]
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28-Jan-2025
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ABOUT THIS PAGE

Looking for 15000-39-2 / Oxytetracycline Hydrochloride API manufacturers, exporters & distributors?

Oxytetracycline Hydrochloride manufacturers, exporters & distributors 1

14

PharmaCompass offers a list of Oxytetracycline Hydrochloride 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 Oxytetracycline Hydrochloride manufacturer or Oxytetracycline Hydrochloride supplier for your needs.

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

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

API | Excipient name

Oxytetracycline Hydrochloride

Synonyms

2058-46-0, Oxytetracycline hcl, Terramycin hydrochloride, Oxytetracycline.hcl, Bisolvomycin, Terramycin

Cas Number

15000-39-2

Unique Ingredient Identifier (UNII)

4U7K4N52ZM

About Oxytetracycline Hydrochloride

A TETRACYCLINE analog isolated from the actinomycete STREPTOMYCES rimosus and used in a wide variety of clinical conditions.

Oxytetracycline Hydrochloride Manufacturers

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

Oxytetracycline Hydrochloride Suppliers

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

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

Oxytetracycline Hydrochloride USDMF

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

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

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

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

Oxytetracycline Hydrochloride CEP

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

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

Oxytetracycline Hydrochloride WC

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

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

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

Finished drug products

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

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

Oxytetracycline Hydrochloride GMP

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

Oxytetracycline Hydrochloride CoA

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

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

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