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1. 1,1'-hbcb
2. Avagard
3. Chlorhexamed
4. Chlorhexidine Bigluconate
5. Chlorhexidine Digluconate
6. Corsodyl Ici
7. Curasept Ads 220
8. Dyna-hex
9. Eludril
10. Gibitan
11. Hexidine
12. Hibiclens
13. Hibident
14. Hibiscrub
15. Hibisol
16. Hibitane
17. Peridex
18. Perio Chip
1. Chlorhexidine Digluconate
2. Hibiclens
3. 18472-51-0
4. Peridex
5. Dyna-hex
6. Bioscrub
7. Chlorhexidine D-digluconate
8. Exidine
9. Microderm
10. Periochip
11. Periogard
12. Unisept
13. Brian Care
14. Steri-stat
15. Cida-stat
16. Hibistat
17. Pharmaseal Scrub Care
18. Chg Scrub
19. Prevacare
20. Chlorhexidine Digluconate Solution
21. Chlorhexidine Di-d-gluconate
22. Mor84mud8e
23. Nsc-753971
24. Hibiscrub
25. Hibitane
26. 1,1'-hexamethylene Bis(5-(p-chlorophenyl)biguanide), Digluconate
27. 1,1'-hexamethylenebis(5-(p-chlorophenyl)biguanide) Di-d-gluconate
28. Bacticlens
29. Chlorhexamed
30. Kleersight
31. Corsodyl
32. Disteryl
33. Hibident
34. Hibidil
35. Orahexal
36. Plurexid
37. Septeal
38. Abacil
39. Fight Bac
40. Plac Out
41. Prevacare R
42. Arlacide G
43. Hibitane 5
44. 2,4,11,13-tetraazatetradecanediimidamide, N,n''-bis(4-chlorophenyl)-3,12-diimino-, Di-d-gluconate
45. Chlorhexidin Glukonatu
46. Peridex (antiseptic)
47. Bactoshield Chg 2%
48. Caswell No. 481g
49. Unii-mor84mud8e
50. Pwriochip
51. Chlorhexidin Glukonatu [czech]
52. 1,6-bis(n5-[p-chlorophenyl]-n1-biguanido)hexane
53. Phiso-med
54. Hibitane Gluconate
55. Hibiclens (tn)
56. Periogard (tn)
57. Drg-0091
58. Einecs 242-354-0
59. Peridex (tn)
60. Mfcd00083599
61. Chlohexidine Gluconate
62. Epa Pesticide Chemical Code 045504
63. Readyprep Chg
64. Chlorhexidine Gluconate [usan:usp:jan]
65. Ec 242-354-0
66. Schembl34468
67. 1,6-bis(5-(p-chlorophenyl)biguandino)hexane Digluconate
68. Chembl4297088
69. Dtxsid5034519
70. Chebi:28312
71. 1,1'-hexamethylenebis(5-(p-chlorophenyl)biguanide) Gluconate
72. 1,1'-hexamethylenebis(5-(p-chlorophenyl)biguanide)digluconate
73. Chx Plus Concentrate Premium Chlorhexidine Teat Dip Concentrate
74. Biguanide, 1,1'-hexamethylenebis(5-(p-chlorophenyl)-, Digluconate
75. Chlorhexidine Gluconate (jp17/usp)
76. Chlorhexidine Gluconate [jan]
77. Chlorhexidine Gluconate [usan]
78. Akos015896303
79. Akos025310696
80. Chlorhexidine Gluconate [mart.]
81. Chlorhexidine Gluconate [vandf]
82. Nsc 753971
83. Chlorhexidine D-digluconate [mi]
84. Chlorhexidine Digluconate [inci]
85. Chlorhexidine Gluconate [who-dd]
86. Gluconic Acid, Compd. With 1,1'-hexamethylene Bis(5-(p-chlorophenyl)biguanide) (2:1), D-
87. D-gluconic Acid, Compd. With N,n''-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediimidamide (2:1)
88. D-gluconic Acid, Compound With N,n''-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine (2:1)
89. Chlorhexidine Gluconate [orange Book]
90. Chlorhexidine Gluconate [usp Impurity]
91. Avagard Component Chlorhexidine Gluconate
92. C08038
93. D00858
94. Chlorhexidine Digluconate Solution, 20% In H2o
95. Soluprep Component Chlorhexidine Gluconate
96. Chloraprep Component Chlorhexidine Gluconate
97. Chlorhexidine Gluconate Component Of Avagard
98. Chlorhexidine Digluconate, 20% W/v Aqueous Solution
99. Chlorhexidine Gluconate Component Of Soluprep
100. J-011837
101. Chlorhexidine Gluconate Component Of Chloraprep
102. Chlorhexidine Digluconate Solution [ep Monograph]
103. 1,1'-hexamethylenebis[5-(4-chlorophenyl)biguanide] Digluconate
104. Chlorhexidine Digluconate, Pharmaceutical Secondary Standard; Certified Reference Material
105. 1,1'-hexamethylenebis[5-(p-chlorophenyl)biguanide] (2r,3s,4r,5r)-2,3,4,5,6-pentahydroxyhexanoic Acid(1:2)
106. 1-(4-chlorophenyl)-3-[n-[6-[[n-[n-(4-chlorophenyl)carbamimidoyl]carbamimidoyl]amino]hexyl]carbamimidoyl]guanidine; (2r,3s,4r,5r)-2,3,4,5,6-pentahydroxyhexanoic Acid
107. 2,4,11,13-tetraazatetradecanediimidamide, N,n''-bis(4-chlorophenyl)-3,12-diimino-, Digluconate
108. 2,4,11,13-tetraazatetradecanediimidamide, N,n'-bis(4-chlorophenyl)-3,12-diimino-, Di-d-gluconate
109. D-gluconic Acid, Compd With N,n''-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediimidamide (2:1)
110. D-gluconic Acid, Compd. With N,n''-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecane Diimidamide (2:1)
111. D-gluconic Acid, Compd. With N1,n14-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediimidamide (2:1)
112. N',n'''''-hexane-1,6-diylbis[n-(4-chlorophenyl)(imidodicarbonimidic Diamide)]--d-gluconic Acid (1/2)
| Molecular Weight | 897.8 g/mol |
|---|---|
| Molecular Formula | C34H54Cl2N10O14 |
| Hydrogen Bond Donor Count | 18 |
| Hydrogen Bond Acceptor Count | 16 |
| Rotatable Bond Count | 23 |
| Exact Mass | 896.3198018 g/mol |
| Monoisotopic Mass | 896.3198018 g/mol |
| Topological Polar Surface Area | 455 Ų |
| Heavy Atom Count | 60 |
| Formal Charge | 0 |
| Complexity | 819 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 8 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 2 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 3 |
| 1 of 2 | |
|---|---|
| Drug Name | Chlorhexidine gluconate |
| Drug Label | Chlorhexidine Gluconate is an oral rinse containing 0.12% chlorhexidine gluconate (1,11-hexamethylene bis[5-(p-chlorophenyl) biguanide] di-D-gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium... |
| Active Ingredient | Chlorhexidine gluconate |
| Dosage Form | Cloth; Solution; Sponge |
| Route | Dental; Topical |
| Strength | 0.12%; 2%; 4% |
| Market Status | Over the Counter; Prescription |
| Company | Lyne; Wockhardt; Sage Prods; Hi Tech Pharma; Teva; Xttrium; Becton Dickinson |
| 2 of 2 | |
|---|---|
| Drug Name | Chlorhexidine gluconate |
| Drug Label | Chlorhexidine Gluconate is an oral rinse containing 0.12% chlorhexidine gluconate (1,11-hexamethylene bis[5-(p-chlorophenyl) biguanide] di-D-gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium... |
| Active Ingredient | Chlorhexidine gluconate |
| Dosage Form | Cloth; Solution; Sponge |
| Route | Dental; Topical |
| Strength | 0.12%; 2%; 4% |
| Market Status | Over the Counter; Prescription |
| Company | Lyne; Wockhardt; Sage Prods; Hi Tech Pharma; Teva; Xttrium; Becton Dickinson |
Antiseptic; disinfectant. (Vet): antiseptic; disinfectant.
O'Neil, M.J. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. Cambridge, UK: Royal Society of Chemistry, 2013., p. 371
Cleanser: As a surgical hand scrub, skin wound and general skin cleanser, health care personnel hand wash, and for preoperative skin preparation. Chlorhedine gluconate significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care. /Chlorhexidine gluconate-topical/
Drug Facts and Comparisons 2013. Wolters Kluwer Health St. Louis, MO 2013, p. 3180
EXPL THER To determine if chlorhexidine can be used as an intervention to prolong the time to relapse of oral candidiasis. SUBJECTS AND METHODS: A double-blinded randomized clinical trial was performed in 75 HIV/AIDS subjects with oral candidiasis. Clotrimazole troche was prescribed, and the subjects were re-examined every 2 weeks until the lesions were completely eradicated. The subjects were then randomly divided into two groups; 0.12% chlorhexidine (n = 37, aged 22-52 years, mean 34 years) and 0.9% normal saline (n = 38, aged 22-55 years, mean 38 years). They were re-examined every 2 weeks until the next episode was observed. RESULTS: The time to recurrence of oral candidiasis between the chlorhexidine and the saline group was not statistically significant (P > 0.05). The following variables were significantly associated with the time of recurrence; frequency of antifungal therapy (P = 0.011), total lymphocyte (P = 0.017), alcohol consumption (P = 0.043), and candidiasis on gingiva (P = 0.048). The subjects with lower lymphocyte showed shorter oral candidiasis-free periods (P = 0.034). CONCLUSIONS: Chlorhexidine showed a small but not statistically significant effect in maintenance of oral candidiasis-free period. This lack of significance may be due to the small sample size. Further study should be performed to better assess the size of the effect, or to confirm our findings.
PMID:18627504 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3253386 Nittayananta W et al; Oral Dis. (7): 665-70 (2008)
/EXPTL Therapy:/ Rats were injected with 10 mg/kg azoxymethane sc weekly for 12 weeks to induce colorectal cancers. At 20 weeks, subtotal colectomies were performed on rats with colorectal tumors and without peritoneal implants or liver metastases. At the time of surgery, a cut portion of the tumor was placed in the abdomen for 30 minutes; the rats then randomly received peritoneal irrigation with chlorhexidine, or sterile water (control). Eight weeks postoperatively a necropsy was performed. At that time, obvious and suspected recurrences and the anastomotic area were sampled for histologic evaluation. Significant differences were seen with chlorhexidine vs. water for gross tumor (P=0.05) and microscopic tumor (P<0.05).
Stuntz M et al; Dis Colon Rectum 40 (9): 1058-8 (1997)
For external use only: For external use only. Keep out of eyes, ears, and mouth. Chlorhexidine gluconate should not be used as a preoperative skin preparation of the face or head. Misuse of products containing chlorhexidine gluconate has been reported to cause serious and permanent eye injury when it has been permitted to enter and remain in the eye during surgical procedures. If chlohexidine gluconate should contact these areas, rinse out promptly and thoroughly with cold water. Avoid contact with neninges. Do not use in genital area. /Chlorhexidine gluconate-topical/
Drug Facts and Comparisons 2013. Wolters Kluwer Health St. Louis, MO 2013, p. 3180
Sensitivity: Chlorhexidine gluconate should not be used by persons who have a sensitivity to it or its components.
Drug Facts and Comparisons 2013. Wolters Kluwer Health St. Louis, MO 2013, p. 3180
Hypersensitivity reactions: Irritation, sensitization, and generalized allergic reactions have been reported with chlorhexidine-containing products, especially in the genital areas. If adverse reactions occur and last more than 72 hr, discontinue use immediately and, if severe, contact a health care provider.
Drug Facts and Comparisons 2013. Wolters Kluwer Health St. Louis, MO 2013, p. 3180
Deafness: Chlorhexidine gluconate has been reported to cause deafness when instilled in the middle ear through perforate ear drums. /Chlorhexidine gluconate-topical/
Drug Facts and Comparisons 2013. Wolters Kluwer Health St. Louis, MO 2013, p. 3180
For more Drug Warnings (Complete) data for CHLORHEXIDINE (8 total), please visit the HSDB record page.
Anti-Infective Agents, Local
Substances used on humans and other animals that destroy harmful microorganisms or inhibit their activity. They are distinguished from DISINFECTANTS, which are used on inanimate objects. (See all compounds classified as Anti-Infective Agents, Local.)
Dermatologic Agents
Drugs used to treat or prevent skin disorders or for the routine care of skin. (See all compounds classified as Dermatologic Agents.)
34 newborn infants who had been bathed in a standard manner with Hibiscrub were studied to find out whether it was absorbed percutaneously. Low levels of chlorhexidine were found in the blood of all 10 babies sampled by heel prick, and 5 of 24 from whom venous blood was taken. /Chlorhexidine gluconate/
PMID:475414 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1545570 Cowen J et al; Arch Dis Child 54 (5): 379-83 (1979)
Percutaneous absorption of the antimicrobial agent chlorhexidine (labelled with carbon-14) was studied in rats. Less than 5% of the topically applied chlorhexidine was absorbed during a 5-day period. Excretion of absorbed radioactivity occurred mainly in the feces.
Chow CP, et al; Toxicol Lett 1(4): 213-16 (1978)
The percutaneous absorption of chlorhexidine gluconate (chlorhexidine digluconate; Hibitane) through hairless rat skin with or without stratum corneum was studied. For tests carried out on whole skin, storage in cutaneous structures after 48 hr was more important than diffusion; the reverse was observed for stripped skin. When the skin was stripped, the amount absorbed was multiplied by approximately 100, and the amount stored in skin by approximately 10. The difference in chlorhexidine diffusion observed between whole and stripped skin was related to the physicochemical characteristics of chlorhexidine. /Chlorhexidine gluconate/
Lafforque C et al; Int J Pharm 147: 243-6 (1997)
To evaluate the elimination kinetics of chlorhexidine in milk when used as an intramammary infusion to stop lactation in cows. ... The study was performed in 2 phases. Three cows were studied in each phase. All cows were treated with chlorhexidine suspension by infusion into a mastitic mammary gland quarter after 2 milkings 24 hours apart. Foremilk samples (100 mL) were collected from treated and untreated (controls) mammary gland quarters of each cow. Chlorhexidine was extracted from raw milk, and residue concentrations were quantified by use of high-performance liquid chromatography. Foremilk samples from days 2, 5, and 8 were analyzed in phase I, and samples from time 0 and days 3, 7, 14, 21, 28, 35, and 42 were analyzed in phase II. In phases I and II, there was no quantifiable transference of chlorhexidine to milk in untreated mammary gland quarters. Measurable chlorhexidine residues were found in milk from treated mammary gland quarters of 2 cows throughout the 42-day sample period in phase II. Estimated mean elimination half-life for chlorhexidine in milk was 11.5 days.
PMID:12830870 Middleton JR et al; J Am Vet Med Assoc 222 (12): 1746-9 (2003)
To evaluate the elimination kinetics of chlorhexidine in milk when used as an intramammary infusion to stop lactation in cows. ... The study was performed in 2 phases. Three cows were studied in each phase. All cows were treated with chlorhexidine suspension by infusion into a mastitic mammary gland quarter after 2 milkings 24 hours apart. Foremilk samples (100 mL) were collected from treated and untreated (controls) mammary gland quarters of each cow. Chlorhexidine was extracted from raw milk, and residue concentrations were quantified by use of high-performance liquid chromatography. Foremilk samples from days 2, 5, and 8 were analyzed in phase I, and samples from time 0 and days 3, 7, 14, 21, 28, 35, and 42 were analyzed in phase II. In phases I and II, there was no quantifiable transference of chlorhexidine to milk in untreated mammary gland quarters. Measurable chlorhexidine residues were found in milk from treated mammary gland quarters of 2 cows throughout the 42-day sample period in phase II. Estimated mean elimination half-life for chlorhexidine in milk was 11.5 days.
PMID:12830870 Middleton JR et al; J Am Vet Med Assoc 222 (12): 1746-9 (2003)
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DOSAGE - AEROSOL, METERED;TOPICAL - 4%
USFDA APPLICATION NUMBER - 19127
DOSAGE - SOLUTION;TOPICAL - 2%
USFDA APPLICATION NUMBER - 19422
DOSAGE - TABLET;DENTAL - 2.5MG
USFDA APPLICATION NUMBER - 20774
DOSAGE - SOLUTION;TOPICAL - 2%;70%
USFDA APPLICATION NUMBER - 208288
DOSAGE - SPONGE;TOPICAL - 2%;70% (1.5ML)
USFDA APPLICATION NUMBER - 20832
DOSAGE - SPONGE;TOPICAL - 2%;70% (10.5ML)
USFDA APPLICATION NUMBER - 20832
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USFDA APPLICATION NUMBER - 20832
DOSAGE - SOLUTION;TOPICAL - 61%;1%
USFDA APPLICATION NUMBER - 21074
DOSAGE - SWAB;TOPICAL - 3.15%;70% (1.6ML)
USFDA APPLICATION NUMBER - 21524
DOSAGE - SWAB;TOPICAL - 3.15%;70% (1ML)
USFDA APPLICATION NUMBER - 21524
DOSAGE - SWAB;TOPICAL - 3.15%;70% (5.1ML)
USFDA APPLICATION NUMBER - 21524
DOSAGE - SWAB;TOPICAL - 2%;70% (0.67ML)
USFDA APPLICATION NUMBER - 21555
DOSAGE - SWAB;TOPICAL - 2%;70% (1.75ML)
USFDA APPLICATION NUMBER - 21555
DOSAGE - SWAB;TOPICAL - 2%;70% (5.25ML)
USFDA APPLICATION NUMBER - 21555
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PharmaCompass offers a list of Chlorhexidine Gluconate 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 Chlorhexidine Gluconate manufacturer or Chlorhexidine Gluconate supplier for your needs.
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A CHLORAPREP ONE-STEP manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CHLORAPREP ONE-STEP, including repackagers and relabelers. The FDA regulates CHLORAPREP ONE-STEP manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CHLORAPREP ONE-STEP 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 CHLORAPREP ONE-STEP manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A CHLORAPREP ONE-STEP supplier is an individual or a company that provides CHLORAPREP ONE-STEP active pharmaceutical ingredient (API) or CHLORAPREP ONE-STEP finished formulations upon request. The CHLORAPREP ONE-STEP suppliers may include CHLORAPREP ONE-STEP API manufacturers, exporters, distributors and traders.
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A CHLORAPREP ONE-STEP DMF (Drug Master File) is a document detailing the whole manufacturing process of CHLORAPREP ONE-STEP active pharmaceutical ingredient (API) in detail. Different forms of CHLORAPREP ONE-STEP DMFs exist exist since differing nations have different regulations, such as CHLORAPREP ONE-STEP USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A CHLORAPREP ONE-STEP DMF submitted to regulatory agencies in the US is known as a USDMF. CHLORAPREP ONE-STEP USDMF includes data on CHLORAPREP ONE-STEP's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CHLORAPREP ONE-STEP USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 CHLORAPREP ONE-STEP Drug Master File in Japan (CHLORAPREP ONE-STEP JDMF) empowers CHLORAPREP ONE-STEP 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 CHLORAPREP ONE-STEP JDMF during the approval evaluation for pharmaceutical products. At the time of CHLORAPREP ONE-STEP 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 CHLORAPREP ONE-STEP suppliers with JDMF on PharmaCompass.
A CHLORAPREP ONE-STEP CEP of the European Pharmacopoeia monograph is often referred to as a CHLORAPREP ONE-STEP Certificate of Suitability (COS). The purpose of a CHLORAPREP ONE-STEP CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of CHLORAPREP ONE-STEP EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of CHLORAPREP ONE-STEP to their clients by showing that a CHLORAPREP ONE-STEP CEP has been issued for it. The manufacturer submits a CHLORAPREP ONE-STEP CEP (COS) as part of the market authorization procedure, and it takes on the role of a CHLORAPREP ONE-STEP CEP holder for the record. Additionally, the data presented in the CHLORAPREP ONE-STEP CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the CHLORAPREP ONE-STEP DMF.
A CHLORAPREP ONE-STEP CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. CHLORAPREP ONE-STEP 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 CHLORAPREP ONE-STEP suppliers with CEP (COS) on PharmaCompass.
A CHLORAPREP ONE-STEP written confirmation (CHLORAPREP ONE-STEP WC) is an official document issued by a regulatory agency to a CHLORAPREP ONE-STEP manufacturer, verifying that the manufacturing facility of a CHLORAPREP ONE-STEP active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting CHLORAPREP ONE-STEP APIs or CHLORAPREP ONE-STEP finished pharmaceutical products to another nation, regulatory agencies frequently require a CHLORAPREP ONE-STEP WC (written confirmation) as part of the regulatory process.
click here to find a list of CHLORAPREP ONE-STEP suppliers with Written Confirmation (WC) on PharmaCompass.
CHLORAPREP ONE-STEP 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 CHLORAPREP ONE-STEP 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 CHLORAPREP ONE-STEP GMP manufacturer or CHLORAPREP ONE-STEP GMP API supplier for your needs.
A CHLORAPREP ONE-STEP CoA (Certificate of Analysis) is a formal document that attests to CHLORAPREP ONE-STEP's compliance with CHLORAPREP ONE-STEP specifications and serves as a tool for batch-level quality control.
CHLORAPREP ONE-STEP CoA mostly includes findings from lab analyses of a specific batch. For each CHLORAPREP ONE-STEP 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.
CHLORAPREP ONE-STEP may be tested according to a variety of international standards, such as European Pharmacopoeia (CHLORAPREP ONE-STEP EP), CHLORAPREP ONE-STEP JP (Japanese Pharmacopeia) and the US Pharmacopoeia (CHLORAPREP ONE-STEP USP).
