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1. Bacitracin A2a
2. Baciguent
3. Fortracin
4. Bacitracinum
5. Parentracin
6. Penitracin
7. Topitracin
8. Zutracin
9. Baciim
10. Baci-rx
11. Solu-tracin 50
12. 22601-59-8
13. Chebi:35862
14. Dda3rrx0p7
15. Altracin
16. Bacitracin A1
17. E700
18. Bacitracin F, 1-(n-((2-(1-amino-2-methylbutyl)-4,5-dihydro-4-thiazolyl)carbonyl)-l-leucine)-
19. Ayfivin
20. Unii-dda3rrx0p7
21. Baciliquin
22. Bacilliquin
23. Bacitracina
24. Bacitracine
25. Mycitracin
26. Topitrasin
27. Tropitracin
28. Septa
29. Spectrocin Plus
30. Bacitek Ointment
31. Nsc-45737
32. Bacitracin Powder
33. Ak-tracin
34. Baci-jel
35. Bacitracin Complex
36. Nsc-755905
37. Baciferm 50
38. Bacitracin, Sterile
39. Einecs 245-115-9
40. Nsc 45737
41. Bacitracine [french]
42. Bacitracinum [latin]
43. Albac 50
44. Bacitracina [spanish]
45. Bactine Triple Antibiotic
46. Bacitracin(non-injectable)
47. Usaf Cb-7
48. Unii-58h6rwo52i
49. Mycitracin Plus Pain Reliever
50. 58h6rwo52i
51. Chembl1200558
52. Schembl20385900
53. Hsdb 6418
54. Bacitracin [usp:inn:ban:jan]
55. Einecs 215-786-2
56. Bdbm50458054
57. Bacitracin-neomycin-polymyxin Ointment
58. Db00626
59. Nsc 755905
60. Ai3-50147-x
61. Campho-phenique Triple Plus Pain Reliever
62. Q424319
63. Mycitracin Triple Antibiotic First Aid Ointment Maximum Strength
64. 85800-09-5
65. L-asparagine, N-(((4r)-2-((1s,2s)-1-amino-2-methylbutyl)-4,5-dihydro-4-thiazolyl)carbonyl)-l-leucyl-d-.alpha.-glutamyl-l-isoleucyl-l-lysyl-d-ornithyl-l-isoleucyl-d-phenylalanyl-l-histidyl-d-.alpha.-aspartyl-, (10->4)-lactam
66. N-({(4r)-2-[(1s,2s)-1-amino-2-methylbutyl]-4,5-dihydro-1,3-thiazol-4-yl}carbonyl)-l-leucyl-d-alpha-glutamyl-n-[(3s,6r,9s,12r,15s,18r,21s)-3-(2-amino-2-oxoethyl)-18-(3-aminopropyl)-12-benzyl-15-[(2s)-butan-2-yl]-6-(carboxymethyl)-9-(1h-imidazol-4-ylmethyl)-2,5,8,11,14,17,20-heptaoxo-1,4,7,10,13,16,19-heptaazacyclopentacosan-21-yl]-l-isoleucinamide
Molecular Weight | 1422.7 g/mol |
---|---|
Molecular Formula | C66H103N17O16S |
XLogP3 | -4.1 |
Hydrogen Bond Donor Count | 17 |
Hydrogen Bond Acceptor Count | 21 |
Rotatable Bond Count | 31 |
Exact Mass | 1421.74894144 g/mol |
Monoisotopic Mass | 1421.74894144 g/mol |
Topological Polar Surface Area | 556 Ų |
Heavy Atom Count | 100 |
Formal Charge | 0 |
Complexity | 2850 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 15 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
1 of 2 | |
---|---|
Drug Name | Baciim |
Drug Label | Bacitracin for Injection, USP is a sterile antibiotic for intramuscular administration. Bacitracin is derived from cultures of Bacillus subtilis (Tracey). It is a white to pale buff, hygroscopic powder, odorless or having a slight odor. It is freely... |
Active Ingredient | Bacitracin |
Dosage Form | Injectable |
Route | Injection |
Strength | 50,000 units/vial |
Market Status | Prescription |
Company | X Gen Pharms |
2 of 2 | |
---|---|
Drug Name | Baciim |
Drug Label | Bacitracin for Injection, USP is a sterile antibiotic for intramuscular administration. Bacitracin is derived from cultures of Bacillus subtilis (Tracey). It is a white to pale buff, hygroscopic powder, odorless or having a slight odor. It is freely... |
Active Ingredient | Bacitracin |
Dosage Form | Injectable |
Route | Injection |
Strength | 50,000 units/vial |
Market Status | Prescription |
Company | X Gen Pharms |
Bacitracin is indicated in topical formulations for acute and chronic localized skin infections. Occasionally, it is also used intramuscularly for infantile streptococcal pneumonia and empyema. Bacitracin is also formulated as an ointment with neomycin and polymyxin B for over the counter use. A bacitracin ointment formulated with neomycin and polymyxin B along with hydrocortisone is indicated for the treatment of corticosteroid responsive dermatoses with secondary infection.
Bacitracin is a mixture of polypeptides that prevent the formation of the bacterial cell wall and oxidatively cleave DNA. It has a short duration of action as it must be given every 3 to 4 hours topically. Bacitracin is nephrotoxic when given intramuscularly and may lead to renal failure.
Absorption
Topical, ophthalmic, and oral formulations of bacitracin are poorly absorbed systemically. Intramuscular bacitracin is readily and completely absorbed.
Route of Elimination
Bacitracin is mainly excreted renally with 87% of and intramuscular dose being recovered in the urine after 6 hours.
Volume of Distribution
Data regarding the volume of distribution of bacitracin in humans is not readily available.
Clearance
Data regarding the clearance of bacitracin in humans has not been well studied. A study of 9 subjects in 1947 shows a renal clearance of 105-283mL/min with an average renal clearance of 159mL/min.
Data regarding the metabolism of bacitracin in humans is not readily available. Because bacitracin is a protein it is expected to be metabolized into smaller polypeptides and amino acids. However, the structure of bacitracin may afford it some protection from the action of proteases.
Data regarding the half life of bacitracin in humans is not readily available.
Bacitracin binds to a divalent metal ion such as Mn(II), Co(II), Ni(II), Cu(II), or Zn(II). These complexes bind C55-isoprenyl pyrophosphate, preventing the hydrolysis of a lipid dolichol pyrophosphate, which finally inhibits cell wall synthesis. Bacitracin metal complexes also bind and oxidatively cleave DNA.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-12-26
Pay. Date : 2012-10-31
DMF Number : 13341
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : CEP 2002-226 - Rev 08
Issue Date : 2024-08-22
Type : Chemical
Substance Number : 465
Status : Valid
Registration Number : 225MF10193
Registrant's Address : 108 Binhai Road, Taizhou, Zhejiang 318000 PRC, China
Initial Date of Registration : 2013-10-09
Latest Date of Registration : --
NDC Package Code : 44231-0002
Start Marketing Date : 2012-12-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23358
Submission : 2009-12-04
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-02-06
Pay. Date : 2014-11-10
DMF Number : 28615
Submission : 2014-08-29
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-04-23
Pay. Date : 2013-09-23
DMF Number : 27510
Submission : 2013-09-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3858
Submission : 1980-07-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19133
Submission : 2006-01-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13340
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13344
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13323
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3858
Submission : 1980-07-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19133
Submission : 2006-01-22
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-17
Pay. Date : 2012-10-31
DMF Number : 13607
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13388
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-26
Pay. Date : 2012-10-31
DMF Number : 13341
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-08
Pay. Date : 2012-10-31
DMF Number : 13608
Submission : 1998-09-01
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13568
Submission : 1998-09-01
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Certificate Number : R0-CEP 2006-052 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2008-11-07
Type : Chemical
Substance Number : 466
Certificate Number : CEP 2017-293 - Rev 01
Status : Valid
Issue Date : 2024-09-18
Type : Chemical
Substance Number : 465
Bacitracin, Micronised, Non-micronised
Certificate Number : CEP 2002-226 - Rev 08
Status : Valid
Issue Date : 2024-08-22
Type : Chemical
Substance Number : 465
Certificate Number : R1-CEP 2002-103 - Rev 10
Status : Valid
Issue Date : 2022-08-18
Type : Chemical
Substance Number : 466
Certificate Number : R1-CEP 2002-224 - Rev 08
Status : Valid
Issue Date : 2018-02-07
Type : Chemical
Substance Number : 465
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Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
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About the Company : ALP Pharm began to manufacture some APIs in the partner's facilities in 2007. Some of our APIs have been approved by EDQM and US FDA. Our professional regulatory compliance experts...
About the Company : Hanways Chempharm Co., Limited, the former one is Hubei Hanways Pharchem CO.,Limited, set up in 2009 in Wuhan, China. We are engaged in supplying APIs, pharmaceutical intermediate...
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API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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ABOUT THIS PAGE
A Bacitracin Zinc manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bacitracin Zinc, including repackagers and relabelers. The FDA regulates Bacitracin Zinc manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bacitracin Zinc 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 Bacitracin Zinc manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bacitracin Zinc supplier is an individual or a company that provides Bacitracin Zinc active pharmaceutical ingredient (API) or Bacitracin Zinc finished formulations upon request. The Bacitracin Zinc suppliers may include Bacitracin Zinc API manufacturers, exporters, distributors and traders.
click here to find a list of Bacitracin Zinc suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bacitracin Zinc DMF (Drug Master File) is a document detailing the whole manufacturing process of Bacitracin Zinc active pharmaceutical ingredient (API) in detail. Different forms of Bacitracin Zinc DMFs exist exist since differing nations have different regulations, such as Bacitracin Zinc USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bacitracin Zinc DMF submitted to regulatory agencies in the US is known as a USDMF. Bacitracin Zinc USDMF includes data on Bacitracin Zinc's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bacitracin Zinc USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bacitracin Zinc suppliers with USDMF on PharmaCompass.
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 Bacitracin Zinc Drug Master File in Japan (Bacitracin Zinc JDMF) empowers Bacitracin Zinc 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 Bacitracin Zinc JDMF during the approval evaluation for pharmaceutical products. At the time of Bacitracin Zinc 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 Bacitracin Zinc suppliers with JDMF on PharmaCompass.
A Bacitracin Zinc CEP of the European Pharmacopoeia monograph is often referred to as a Bacitracin Zinc Certificate of Suitability (COS). The purpose of a Bacitracin Zinc CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Bacitracin Zinc EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Bacitracin Zinc to their clients by showing that a Bacitracin Zinc CEP has been issued for it. The manufacturer submits a Bacitracin Zinc CEP (COS) as part of the market authorization procedure, and it takes on the role of a Bacitracin Zinc CEP holder for the record. Additionally, the data presented in the Bacitracin Zinc CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Bacitracin Zinc DMF.
A Bacitracin Zinc CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Bacitracin Zinc 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 Bacitracin Zinc suppliers with CEP (COS) on PharmaCompass.
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 Bacitracin Zinc as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Bacitracin Zinc API and other APIs are published in this directory by the FDA.
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 Bacitracin Zinc 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.
The NDC directory also contains data on finished compounded human drug products that contain Bacitracin Zinc and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Bacitracin Zinc NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Bacitracin Zinc suppliers with NDC on PharmaCompass.
Bacitracin Zinc 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 Bacitracin Zinc 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 Bacitracin Zinc GMP manufacturer or Bacitracin Zinc GMP API supplier for your needs.
A Bacitracin Zinc CoA (Certificate of Analysis) is a formal document that attests to Bacitracin Zinc's compliance with Bacitracin Zinc specifications and serves as a tool for batch-level quality control.
Bacitracin Zinc CoA mostly includes findings from lab analyses of a specific batch. For each Bacitracin Zinc 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.
Bacitracin Zinc may be tested according to a variety of international standards, such as European Pharmacopoeia (Bacitracin Zinc EP), Bacitracin Zinc JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bacitracin Zinc USP).
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