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Ciprofloxacin Hydrochloride

Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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ACTIVE PHARMA INGREDIENTS

54 API Suppliers, 23 USDMF, 18 CEP/COS, 3 JDMF, 11 EU WC, 19 KDMF, 21 NDC API, 22 Listed Suppliers, $ API Reference Price

54 API Suppliers
23 USDMF
18 CEP/COS
3 JDMF
11 EU WC
19 KDMF
21 NDC API
22 Listed Suppliers
$ API Reference Price

FINISHED DOSAGE FORMULATIONS

212 FDF Dossiers, 87 FDA Orange Book, 39 Europe, 36 Canada, 1 South Africa, 49 Listed Dossiers

212 FDF Dossiers
87 FDA Orange Book
39 Europe
36 Canada
1 South Africa
49 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION/DROPS;OPHTHALMIC - EQ 0.3% BASE, OINTMENT;OPHTHALMIC - EQ 0.3% BASE, SUSPENSION/DROPS;OTIC - EQ 0.2% BASE;1%

drugProductComposition
SOLUTION/DROPS;OPHTHALMIC - EQ 0.3% BASE
OINTMENT;OPHTHALMIC - EQ 0.3% BASE
SUSPENSION/DROPS;OTIC - EQ 0.2% BASE;1%

RELATED EXCIPIENT COMPANIES

3 Rochem International Inc, 17 SPI Pharma, 2 Seqens, 7 DKSH, 8 Faran Shimi Pharmaceutical, 8 Boai NKY Pharmaceuticals Ltd, 14 Gangwal Healthcare, 8 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 ACG Worldwide, 15 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 34 BASF, 2 Clariant, 11 Corel Pharma Chem, 1 Curia, 6 DFE Pharma, 4 Finar, 13 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 33 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 16 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 4 Novo Excipients, 4 Pharmatrans-Sanaq, 9 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 27 Roquette, 15 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem

relatedExcipients
3 Rochem International Inc
17 SPI Pharma
2 Seqens
7 DKSH
8 Faran Shimi Pharmaceutical
8 Boai NKY Pharmaceuticals Ltd
14 Gangwal Healthcare
8 Nanjing Well Pharmaceutical
2 Pfanstiehl
1 ACG Worldwide
15 Actylis
1 Aeon Procare
1 Alcedo Pharmachem
9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
34 BASF
2 Clariant
11 Corel Pharma Chem
1 Curia
6 DFE Pharma
4 Finar
13 Gangwal Chemicals
7 Ideal Cures Pvt Ltd
5 Ingredion Pharma Solutions
33 Kerry
4 Kima Chemical
6 Lonza Capsugel
16 Microlex e.U
1 Nanjing Bold Chemical
2 Nomisma Healthcare
4 Novo Excipients
4 Pharmatrans-Sanaq
9 Pluviaendo
4 Prachin Chemical
1 Qianhao Chemical (Hebei) Co., Ltd
1 Qualicaps
27 Roquette
15 Seppic
7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shanghai Welltone Material Technology Co., Ltd
1 Shijiazhuang Huaxu Pharmaceutical
12 Sigachi Industries
3 The Dow Chemical Company
2 Ulanqab Kema New Material
1 Valens Pharmachem
4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

94 Fillers, Diluents & Binders, 57 Coating Systems & Additives, 48 Direct Compression, 41 Disintegrants & Superdisintegrants, 38 Solubilizers, 34 Controlled & Modified Release, 33 Granulation, 33 Thickeners and Stabilizers, 29 Parenteral, 26 Topical, 24 Taste Masking, 22 Lubricants & Glidants, 21 Co-Processed Excipients, 20 Film Formers & Plasticizers, 18 Chewable & Orodispersible Aids, 10 Emulsifying Agents, 8 API Stability Enhancers, 6 Surfactant & Foaming Agents, 5 Empty Capsules, 5 Coloring Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules

DIGITAL CONTENT

8 DATA COMPILATION #PharmaFlow, 15 NEWS #PharmaBuzz

media
8 DATA COMPILATION #PharmaFlow
15 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 6 Finished Drug Prices

globalSalesInformation
3 US Medicaid Prescriptions
6 Finished Drug Prices

MARKET PLACE

43 APIs, 3 FDF Dossiers

marketPlace
43 APIs
3 FDF Dossiers

PATENTS & EXCLUSIVITIES

1 US Patents, 10 Health Canada Patents

patents
1 US Patents
10 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM , 1 USP , 1 Others

otherSolutions
3 EDQM
1 USP
1 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 26

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

212

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

0 DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

3,226,129

Annual Reports (USD Million)

Finished Drug Prices

337 RELATED EXCIPIENT COMPANIES

581EXCIPIENTS BY APPLICATIONS

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

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 Formula	C₁₇H₁₉ClFN₃O₃
Molecular Weight	367.8 g/mol
Hydrogen Bond Donor Count	3
Hydrogen Bond Acceptor Count	7
Rotatable Bond Count	3
Exact Mass	367.1098973 g/mol
Monoisotopic Mass	367.1098973 g/mol
Topological Polar Surface Area	72.9 Å²
Heavy Atom Count	25
Formal Charge	0
Complexity	571
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Ciprofloxacin hydrochloride
PubMed Health	Ciprofloxacin Betaine/Ciprofloxacin Hydrochloride (By mouth)
Drug Classes	Antibacterial
Drug Label	Ciprofloxacin 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 Ingredient	Ciprofloxacin hydrochloride
Dosage Form	Solution/drops; Tablet
Route	Ophthalmic; Oral
Strength	eq 100mg base; eq 750mg base; eq 500mg base; eq 0.3% base; eq 250mg base
Market Status	Prescription
Company	Watson 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 Name	Ciprofloxacin hydrochloride
PubMed Health	Ciprofloxacin Betaine/Ciprofloxacin Hydrochloride (By mouth)
Drug Classes	Antibacterial
Drug Label	Ciprofloxacin 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 Ingredient	Ciprofloxacin hydrochloride
Dosage Form	Solution/drops; Tablet
Route	Ophthalmic; Oral
Strength	eq 100mg base; eq 750mg base; eq 500mg base; eq 0.3% base; eq 250mg base
Market Status	Prescription
Company	Watson 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 SUPPLIERS

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USDMF

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CEP/COS

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JDMF

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EU WC

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KDMF

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NDC API

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API Reference Price

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PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"J.B.CHEMICALS & PHARMACEUTICALS","customerCountry":"INDIA","quantity":"5000.00","actualQuantity":"5000","unit":"KGS","unitRateFc":"45","totalValueFC":"227205","currency":"USD","unitRateINR":"3818.3","date":"11-Oct-2024","totalValueINR":"19091250","totalValueInUsd":"227205","indian_port":"JNPT","hs_no":"29419030","bill_no":"6073276","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO.6 WEIWU ROAD, HANGZHOU GULF, SHA NGYU ECONOMIC AND TECHNOLOGICAL DEV ELOPMENT ZONE ,ZHEJIANG, CHINA China","customerAddress":"NEELAM CENTRE, B WING, 4TH FLOOR"}]

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DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.3% ...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.3% BASE

USFDA APPLICATION NUMBER - 19992

DOSAGE - OINTMENT;OPHTHALMIC - EQ 0.3% BASE

USFDA APPLICATION NUMBER - 20369

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

Ciprofloxacin Hydrochloride Manufacturers

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

Ciprofloxacin Hydrochloride Suppliers

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

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

Ciprofloxacin Hydrochloride USDMF

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

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

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

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

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

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

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

Ciprofloxacin Hydrochloride CEP

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

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

Ciprofloxacin Hydrochloride WC

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

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

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

Finished drug products

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

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

Ciprofloxacin Hydrochloride GMP

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

Ciprofloxacin Hydrochloride CoA

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

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

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

54 API Suppliers

23 USDMF

18 CEP/COS

3 JDMF

11 EU WC

19 KDMF

21 NDC API

22 Listed Suppliers

$ API Reference Price

FINISHED DOSAGE FORMULATIONS

212 FDF Dossiers

87 FDA Orange Book

39 Europe

36 Canada

1 South Africa

49 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION/DROPS;OPHTHALMIC - EQ 0.3% BASE

OINTMENT;OPHTHALMIC - EQ 0.3% BASE

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

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