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Chemistry

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Also known as: Ciprofloxacin hcl, 93107-08-5, 86483-48-9, 1-cyclopropyl-6-fluoro-4-oxo-7-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic acid hydrochloride, Cipro, Chebi:310388
Molecular Formula
C17H19ClFN3O3
Molecular Weight
367.8  g/mol
InChI Key
DIOIOSKKIYDRIQ-UHFFFAOYSA-N
FDA UNII
0MP32MFP6C

Ciprofloxacin Hydrochloride
A broad-spectrum antimicrobial carboxyfluoroquinoline.
1 2D Structure

Ciprofloxacin Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
1-cyclopropyl-6-fluoro-4-oxo-7-piperazin-1-ylquinoline-3-carboxylic acid;hydrochloride
2.1.2 InChI
InChI=1S/C17H18FN3O3.ClH/c18-13-7-11-14(8-15(13)20-5-3-19-4-6-20)21(10-1-2-10)9-12(16(11)22)17(23)24;/h7-10,19H,1-6H2,(H,23,24);1H
2.1.3 InChI Key
DIOIOSKKIYDRIQ-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C1CC1N2C=C(C(=O)C3=CC(=C(C=C32)N4CCNCC4)F)C(=O)O.Cl
2.2 Other Identifiers
2.2.1 UNII
0MP32MFP6C
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Anhydrous, Ciprofloxacin Hydrochloride

2. Bay 09867

3. Bay-09867

4. Bay09867

5. Ciprinol

6. Cipro

7. Ciprofloxacin

8. Ciprofloxacin Hydrochloride Anhydrous

9. Ciprofloxacin Monohydrochloride Monohydrate

10. Hydrochloride Anhydrous, Ciprofloxacin

11. Hydrochloride, Ciprofloxacin

12. Monohydrate, Ciprofloxacin Monohydrochloride

13. Monohydrochloride Monohydrate, Ciprofloxacin

2.3.2 Depositor-Supplied Synonyms

1. Ciprofloxacin Hcl

2. 93107-08-5

3. 86483-48-9

4. 1-cyclopropyl-6-fluoro-4-oxo-7-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic Acid Hydrochloride

5. Cipro

6. Chebi:310388

7. Ciprofloxacin Hydrochloride Anhydrous

8. 0mp32mfp6c

9. 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic Acid Hydrochloride

10. Ciprofloxacin (monohydrochloride)

11. Bay-o-9867

12. Ciprofloxacin Hydrochloride (anh.)

13. Bay O 9867

14. Cetraxal

15. Ciprobay

16. Ciproxan

17. Ciproxin

18. Flociprin

19. Ciflox

20. Mfcd00079044

21. 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic Acid Hcl

22. 1-cyclopropyl-6-fluoro-4-oxo-7-piperazin-1-ylquinoline-3-carboxylic Acid;hydrochloride

23. 1-cyclopropyl-6-fluoro-4-oxo-7-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic Acid Xhydrochloride

24. Bay-o 9867

25. 93107-08-5 (hcl)

26. 1-cyclopropyl-6-fluoro-4-oxo-7-(1-piperazinyl)-1,4-dihydro-3-quinolinecarboxylic Acid Hydrochloride

27. Dsstox_cid_27768

28. Dsstox_rid_82545

29. Dsstox_gsid_47788

30. Ciprofloxacin (as Hydrochloride)

31. Prestwick_67

32. 1-cyclopropyl-6-fluoro-4-oxo-7-piperazin-1-yl-1,4-dihydro-quinoline-3-carboxylic Acid; Hydrochloride

33. 4-(3-carboxy-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydro-quinolin-7-yl)-piperazin-1-ium; Chloride

34. Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic Acid, Monohydrochloride

35. Nsc620634

36. Ciprofloxacin Hydrochloride (anhydrous)

37. Ciprofloxacin 100 Microg/ml In Methanol

38. Ncgc00016959-01

39. Cas-93107-08-5

40. Unii-0mp32mfp6c

41. 3-quinolinecarboxylic Acid, 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-, Hydrochloride

42. 3-quiolinecarboxylic Acid

43. Ciprofloxacine Hydrochloride

44. Epitope Id:174846

45. Cambridge Id 5807784

46. Ciprofloxacini Hydrochloridum

47. Chembl1202

48. Schembl42310

49. 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic Acid Monohydrochloride

50. 3-quinolinecarboxylic Acid, 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-, Monohydrochloride

51. Ciprofloxacin Hcl/lactate

52. Dtxsid1047788

53. Hy-b0356a

54. Ciprofloxacin Hydrochloride (1:x)

55. Hms1568g08

56. Bcp13634

57. Bcp14336

58. Tox21_110712

59. S5008

60. Akos005111008

61. Tox21_110712_1

62. Cs-8134

63. Ks-5012

64. Nsc-620634

65. Sb73037

66. Ncgc00016959-06

67. 3-quinolinecarboxylic Acid, 1,4-dihydro-1-cyclopropyl-6-fluoro-4-oxo-7-(1-piperazinyl)-, Hydrochloride

68. Ac-23972

69. Bim-0048462.p001

70. Ciprofloxacin 1000 Microg/ml In Methanol

71. Ciprofloxacin Hydrochloride [who-dd]

72. Ft-0623850

73. Ft-0623851

74. A16969

75. H10663

76. A859872

77. Q-200860

78. Q27105154

79. F0001-2378

80. Cpx; Cetraxal; Ciloxan; Cipro; Bay-09867 Hydrochloride

81. 1-cyclopropyl-6-fluoro-4-oxo-7-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic Acid Hcl

82. 1-cyclopropyl-6-fluoro-4-oxo-7-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylicacidxhydrochloride

83. 3-quinolinecarboxylic Acid, 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-, Hydrochloride (1:1)

2.4 Create Date
2005-03-26
3 Chemical and Physical Properties
Molecular Weight 367.8 g/mol
Molecular Formula C17H19ClFN3O3
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count7
Rotatable Bond Count3
Exact Mass367.1098973 g/mol
Monoisotopic Mass367.1098973 g/mol
Topological Polar Surface Area72.9 Ų
Heavy Atom Count25
Formal Charge0
Complexity571
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 NameCiprofloxacin hydrochloride
PubMed HealthCiprofloxacin Betaine/Ciprofloxacin Hydrochloride (By mouth)
Drug ClassesAntibacterial
Drug LabelCiprofloxacin Tablets, USPis a synthetic broad spectrum antimicrobial agent for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-pip...
Active IngredientCiprofloxacin hydrochloride
Dosage FormSolution/drops; Tablet
RouteOphthalmic; Oral
Strengtheq 100mg base; eq 750mg base; eq 500mg base; eq 0.3% base; eq 250mg base
Market StatusPrescription
CompanyWatson Labs; Nexus Pharms; Ranbaxy; Ivax Sub Teva Pharms; Apotex; Bausch And Lomb; Aurobindo Pharma; Taro; Dr Reddys Labs; Unique Pharm Labs; Carlsbad; Pharmaforce; Fdc; Mylan; Hikma; Akorn

2 of 2  
Drug NameCiprofloxacin hydrochloride
PubMed HealthCiprofloxacin Betaine/Ciprofloxacin Hydrochloride (By mouth)
Drug ClassesAntibacterial
Drug LabelCiprofloxacin Tablets, USPis a synthetic broad spectrum antimicrobial agent for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-pip...
Active IngredientCiprofloxacin hydrochloride
Dosage FormSolution/drops; Tablet
RouteOphthalmic; Oral
Strengtheq 100mg base; eq 750mg base; eq 500mg base; eq 0.3% base; eq 250mg base
Market StatusPrescription
CompanyWatson Labs; Nexus Pharms; Ranbaxy; Ivax Sub Teva Pharms; Apotex; Bausch And Lomb; Aurobindo Pharma; Taro; Dr Reddys Labs; Unique Pharm Labs; Carlsbad; Pharmaforce; Fdc; Mylan; Hikma; Akorn

4.2 Drug Indication

Treatment of chronic pulmonary infections caused by Pseudomonas aeruginosa


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.)


Topoisomerase II Inhibitors

Compounds that inhibit the activity of DNA TOPOISOMERASE II. Included in this category are a variety of ANTINEOPLASTIC AGENTS which target the eukaryotic form of topoisomerase II and ANTIBACTERIAL AGENTS which target the prokaryotic form of topoisomerase II. (See all compounds classified as Topoisomerase II Inhibitors.)


Cytochrome P-450 CYP1A2 Inhibitors

Drugs and compounds which inhibit or antagonize the biosynthesis or actions of CYTOCHROME P-450 CYP1A2. (See all compounds classified as Cytochrome P-450 CYP1A2 Inhibitors.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Quinolones [CS]; Quinolone Antimicrobial [EPC]

API Reference Price

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M.G.ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1744569000,"product":"CIPROFLOXACIN HYDROCHLORIDE USP CIPROFLOXACIN HYDROCHLORIDE USP","address":"701-ARUN CHAMBERS,80 TARDEO ROAD,","city":"MAHARASHTRA","supplier":"ZHEJIANG JINGXIN PHARMACEUTICAL IMPORT EXPORT","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"PRADIPKUMAR PHARMA PRIVATE LTD","customerCountry":"INDIA","quantity":"1500.00","actualQuantity":"1500","unit":"KGS","unitRateFc":"16.8","totalValueFC":"25554.7","currency":"USD","unitRateINR":"1458.4","date":"14-Apr-2025","totalValueINR":"2187530.65","totalValueInUsd":"25554.7","indian_port":"JNPT SEZ\/MUMBAI","hs_no":"29419030","bill_no":"9480513","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"CO., LTD. NO.800, DADAO EAST ROAD, CHENGGUAN, XINCHANG COUNTY, ZHEJIAN G, CHINA ., ., China China","customerAddress":"701-ARUN CHAMBERS,80 TARDEO ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1744655400,"product":"CIPROFLOXACIN HYDROCHLORIDE USP CIPROFLOXACIN HYDROCHLORIDE USP","address":"NEELAM CENTRE, B WING, 4TH FLOOR","city":"MUMBAI,MAHARASHTRA","supplier":"ZHEJIANG GUOBANG PHARMACEUTICAL CO","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"J B CHEMICALS AND PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"2000.09","actualQuantity":"2000.09","unit":"KGS","unitRateFc":"45","totalValueFC":"91053.6","currency":"USD","unitRateINR":"3897","date":"15-Apr-2025","totalValueINR":"7794350.73","totalValueInUsd":"91053.6","indian_port":"Bombay Air","hs_no":"29419030","bill_no":"9499510","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":",LTD NO.6 WEIWU ROAD, HANGZHOU GULF SHANGYU ECONOMIC AND TECHNOLOGICAL. 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ZHEJIANG CHINA 312369 CHINA","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1749753000,"product":"CIPROFLOXACIN HYDROCHLORIDE PH EUR CHEMICAL","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"ZHEJIANG GUOBANG PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"AUROBINDO PHARMA LTD","customerCountry":"INDIA","quantity":"4500.00","actualQuantity":"4500","unit":"KGS","unitRateFc":"36.3","totalValueFC":"164917.6","currency":"USD","unitRateINR":"3149","date":"13-Jun-2025","totalValueINR":"14170612.5","totalValueInUsd":"164917.6","indian_port":"Madras Sea","hs_no":"29419030","bill_no":"2635139","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO 6 WEIWU ROAD HANGZHOU GULF SHANG YU ECONOMIC AND TECHNOLOGICAL DEVEL OPMENT ZONE ZHEJIANG CHINA 312369 CHINA","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1749839400,"product":"CIPROFLOXACIN HCL BP\/USP (CIPROFLOXACIN HCL USP) CIPROFLOXACIN HCL USP","address":"25, 2ND PULIYUR MAIN ROAD,","city":"CHENNAI, TAMILNADU","supplier":"ZHEJIANG GUOBANG PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"MEDOPHARM","customerCountry":"INDIA","quantity":"289.00","actualQuantity":"289","unit":"KGS","unitRateFc":"17","totalValueFC":"4960.1","currency":"USD","unitRateINR":"1474.8","date":"14-Jun-2025","totalValueINR":"426202.75","totalValueInUsd":"4960.1","indian_port":"Madras Sea","hs_no":"29419030","bill_no":"2657239","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO.6, WEIWU ROAD HANGZHOU GULF, SHANGYU ECONOMIC & TECHNOLOGICAL DEVELOPMENT ZONE,ZHEJIANG, CHINA","customerAddress":"25, 2ND PULIYUR MAIN ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1750357800,"product":"CIPROFLOXACIN HYDROCHLORIDE CHEMICAL","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"ZHEJIANG GUOBANG PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"CHENGDU","customer":"AUROBINDO PHARMA LTD","customerCountry":"INDIA","quantity":"8233.00","actualQuantity":"8233","unit":"KGS","unitRateFc":"45","totalValueFC":"377574.3","currency":"USD","unitRateINR":"3940.6","date":"20-Jun-2025","totalValueINR":"32443233.37","totalValueInUsd":"377574.3","indian_port":"Madras Air","hs_no":"29419030","bill_no":"2777914","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"CHENGDU","supplierAddress":"NO 6 WEIWU ROAD HANGZHOU GULF SHANG YU ECONOMIC AND TECHNOLOGICAL DEVEL OPMENT ZONE ZHEJIANG CHINA 312369 CHINA","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1750962600,"product":"CIPROFLOXACIN HCL IP\/USP CIPROFLOXACIN HCL IP\/USP","address":"NO.54-55, INDUSTRIAL AREA,","city":"CHANDIGARH.","supplier":"ZHEJIANG GUOBANG PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"SCOTT EDIL PHARMACIA LTD","customerCountry":"INDIA","quantity":"3395.00","actualQuantity":"3395","unit":"KGS","unitRateFc":"17.9","totalValueFC":"62056.3","currency":"USD","unitRateINR":"1570.6","date":"27-Jun-2025","totalValueINR":"5332216.59","totalValueInUsd":"62056.3","indian_port":"JNPT","hs_no":"29419030","bill_no":"2900859","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO.6,WEIWU ROAD, HANGZHOU GULF SHAN GYU ECONOMIC AND TECHNOLOGICAL DEVE LOPMENT ZONE, ZHEJIANG, CHINA CHINA","customerAddress":"NO.54-55, INDUSTRIAL AREA,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1753727400,"product":"CIPROFLOXACIN HYDROCHLORIDE [ I.P\/ U.S.P ] CIPROFLOXACIN HYDROCHLORIDE [ I.P\/ U.S.P ]","address":"142-48 S.V.ROAD,","city":"MUMBAI, MAHARASHTRA","supplier":"ZHEJIANG GUOBANG PHARMACEUTICAL CO","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"FDC LTD","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"215","totalValueFC":"5420.8","currency":"USD","unitRateINR":"18662","date":"29-Jul-2025","totalValueINR":"466550","totalValueInUsd":"5420.8","indian_port":"Bombay Air","hs_no":"29335990","bill_no":"3562205","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"LTD.NO.6, WEIWU ROAD, HANGZHOU GUL FSHANGYU INDUSTRIAL ZONE, ZHEJIANG SDNF CHINA","customerAddress":"142-48 S.V.ROAD,"}]
05-Jan-2022
30-Jul-2025
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DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.3% ...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.3% BASE

USFDA APPLICATION NUMBER - 19992

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DOSAGE - OINTMENT;OPHTHALMIC - EQ 0.3% BASE

USFDA APPLICATION NUMBER - 20369

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DOSAGE - SUSPENSION/DROPS;OTIC - EQ 0.2% BASE...DOSAGE - SUSPENSION/DROPS;OTIC - EQ 0.2% BASE;1%

USFDA APPLICATION NUMBER - 20805

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ABOUT THIS PAGE

Looking for 86483-48-9 / Ciprofloxacin Hydrochloride API manufacturers, exporters & distributors?

Ciprofloxacin Hydrochloride manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Ciprofloxacin Hydrochloride

Synonyms

Ciprofloxacin hcl, 93107-08-5, 86483-48-9, 1-cyclopropyl-6-fluoro-4-oxo-7-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic acid hydrochloride, Cipro, Chebi:310388

Cas Number

86483-48-9

Unique Ingredient Identifier (UNII)

0MP32MFP6C

About Ciprofloxacin Hydrochloride

A broad-spectrum antimicrobial carboxyfluoroquinoline.

Ciprinol Manufacturers

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

Ciprinol Suppliers

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

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

Ciprinol USDMF

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

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

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

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

Ciprinol KDMF

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

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

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

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

Ciprinol CEP

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

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

Ciprinol WC

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

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

Ciprinol 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 Ciprinol as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Ciprinol GMP

Ciprinol 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 Ciprinol 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 Ciprinol GMP manufacturer or Ciprinol GMP API supplier for your needs.

Ciprinol CoA

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

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

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