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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.
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API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Bimixin
Dosage Form :
Dosage Strength : 16 Cpr 2,500 Iu + 25,000 Iu
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Bimixin
Dosage Form :
Dosage Strength : The Scir 60 Ml 15,000 Iu + 150,000 Iu
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info : DISCN
Registration Country : USA
BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Brand Name : ZINC BACITRACIN,NEOMYCIN SULFATE,POLYMYXIN B SULFATE & HYDROCORTISONE
Dosage Form : OINTMENT;OPHTHALMIC
Dosage Strength : 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
Packaging :
Approval Date : 1982-07-02
Application Number : 62389
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Brand Name : LUMI-SPORYN
Dosage Form : OINTMENT;OPHTHALMIC
Dosage Strength : 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM
Packaging :
Approval Date : 1982-01-01
Application Number : 50417
Regulatory Info : RX
Registration Country : USA
Regulatory Info : OTC
Registration Country : Canada
Brand Name : POLYSPORIN COMPLETE
Dosage Form : OINTMENT
Dosage Strength : 500UNIT/G
Packaging : 15/30G
Approval Date :
Application Number : 2240568
Regulatory Info : OTC
Registration Country : Canada
Regulatory Info : RX
Registration Country : USA
BACITRACIN ZINC; POLYMYXIN B SULFATE
Brand Name : BACITRACIN ZINC AND POLYMYXIN B SULFATE
Dosage Form : OINTMENT;OPHTHALMIC
Dosage Strength : 500 UNITS/GM;10,000 UNITS/GM
Packaging :
Approval Date : 2002-02-27
Application Number : 65022
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : BACIGUENT
Dosage Form : OINTMENT;OPHTHALMIC
Dosage Strength : 500 UNITS/GM
Packaging :
Approval Date : 1982-01-01
Application Number : 60734
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : BACITRACIN
Dosage Form : OINTMENT;OPHTHALMIC
Dosage Strength : 500 UNITS/GM
Packaging :
Approval Date : 1982-01-01
Application Number : 62158
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : OTC
Registration Country : Canada
Brand Name : ANTIBIOTIC OINTMENT
Dosage Form : OINTMENT
Dosage Strength : 500UNIT
Packaging : 30G
Approval Date :
Application Number :
Regulatory Info : OTC
Registration Country : Canada
Regulatory Info :
Registration Country : USA
Brand Name : BACITRACIN
Dosage Form : Injectable; Injection
Dosage Strength : 10,000 UNITS/VIAL
Packaging :
Approval Date :
Application Number : 62696
Regulatory Info :
Registration Country : USA
RLD : No
TE Code :
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Brand Name : BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE
Dosage Form : OINTMENT;OPHTHALMIC
Dosage Strength : 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM
Approval Date : 1982-09-09
Application Number : 62386
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Brand Name : ZINC BACITRACIN,NEOMYCIN SULFATE,POLYMYXIN B SULFATE & HYDROCORTISONE
Dosage Form : OINTMENT;OPHTHALMIC
Dosage Strength : 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
Approval Date : 1982-07-02
Application Number : 62389
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
BACITRACIN ZINC; POLYMYXIN B SULFATE
Brand Name : OCUMYCIN
Dosage Form : OINTMENT;OPHTHALMIC
Dosage Strength : 500 UNITS/GM;10,000 UNITS/GM
Approval Date : 1983-04-08
Application Number : 62430
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : BACITRACIN
Dosage Form : OINTMENT;OPHTHALMIC
Dosage Strength : 500 UNITS/GM
Approval Date : 1984-03-28
Application Number : 62453
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Brand Name : NEO-POLYCIN
Dosage Form : OINTMENT;OPHTHALMIC
Dosage Strength : 500 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM
Approval Date : 1982-01-01
Application Number : 60647
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
BACITRACIN ZINC; POLYMYXIN B SULFATE
Brand Name : POLYSPORIN
Dosage Form : OINTMENT;OPHTHALMIC
Dosage Strength : 500 UNITS/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**
Approval Date : 1982-01-01
Application Number : 61229
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Brand Name : NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE
Dosage Form : OINTMENT;OPHTHALMIC
Dosage Strength : 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
Approval Date : 2012-07-25
Application Number : 65213
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : BACI-RX
Dosage Form : POWDER;FOR RX COMPOUNDING
Dosage Strength : 5,000,000 UNITS/BOT
Approval Date : 1982-01-01
Application Number : 61580
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
BACITRACIN; POLYMYXIN B SULFATE
Brand Name : LANABIOTIC
Dosage Form : DISC;TOPICAL
Dosage Strength : 500 UNITS/GM;5,000 UNITS/GM
Approval Date : 1986-09-22
Application Number : 50598
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
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Corporate PDF
BACITRACIN ZINC; POLYMYXIN B SULFATE
Brand Name : BACITRACIN ZINC-POLYMYXIN B SULFATE
Dosage Form : OINTMENT;TOPICAL
Dosage Strength : 500 UNITS/GM;10,000 UNITS/GM
Approval Date : 1987-11-13
Application Number : 62849
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Bimixin
Dosage Form :
Dosage Strength : 16 Cpr 2,500 Iu + 25,000 Iu
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Italy
Brand Name : Bimixin
Dosage Form :
Dosage Strength : The Scir 60 Ml 15,000 Iu + 150,000 Iu
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Orobicin
Dosage Form :
Dosage Strength : 16 Cpr 2,500 Iu + 25,000 Iu
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Enterostop
Dosage Form :
Dosage Strength : 20 Cpr 2,500 Iu + 25 Mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : OTC
Registration Country : Canada
Brand Name : OZONOL ANTIBIOTICS PLUS
Dosage Form : OINTMENT
Dosage Strength : 500UNIT/G
Packaging : 30G
Approval Date :
Application Number : 2236917
Regulatory Info : OTC
Registration Country : Canada
Regulatory Info : OTC
Registration Country : Canada
Brand Name : JAMPOLYCIN
Dosage Form : OINTMENT
Dosage Strength : 500UNIT/G
Packaging : 15/30G
Approval Date :
Application Number : 2357569
Regulatory Info : OTC
Registration Country : Canada
Regulatory Info : OTC
Registration Country : Canada
Brand Name : BAND-AID BRAND ADHESIVE BANDAGES PLUS ANTIBIOTIC
Dosage Form : OINTMENT
Dosage Strength : 500UNIT/G
Packaging : 20 PADS
Approval Date :
Application Number : 2236954
Regulatory Info : OTC
Registration Country : Canada
Regulatory Info : OTC
Registration Country : Canada
Brand Name : POLYSPORIN ANTIBIOTIC OINTMENT
Dosage Form : OINTMENT
Dosage Strength : 500UNIT/G
Packaging : 0.9/15/30G
Approval Date :
Application Number : 2237227
Regulatory Info : OTC
Registration Country : Canada
Regulatory Info : OTC
Registration Country : Canada
Brand Name : BACITIN
Dosage Form : OINTMENT
Dosage Strength : 500UNIT/G
Packaging : 15G/30G
Approval Date :
Application Number : 584908
Regulatory Info : OTC
Registration Country : Canada
Regulatory Info : OTC
Registration Country : Canada
Brand Name : BACIMYXIN ONGUENT
Dosage Form : OINTMENT
Dosage Strength : 500UNIT
Packaging : 5/15/30G
Approval Date :
Application Number :
Regulatory Info : OTC
Registration Country : Canada
Regulatory Info : OTC
Registration Country : Canada
Brand Name : ANTIBIOTIC OINTMENT
Dosage Form : OINTMENT
Dosage Strength : 500UNIT
Packaging : 30G
Approval Date :
Application Number :
Regulatory Info : OTC
Registration Country : Canada
Regulatory Info : OTC
Registration Country : Canada
Brand Name : ANTIBIOTIC OINTMENT USP
Dosage Form : OINTMENT
Dosage Strength : 500UNIT/G
Packaging : 15G
Approval Date :
Application Number : 2230251
Regulatory Info : OTC
Registration Country : Canada
Regulatory Info : OTC
Registration Country : Canada
Brand Name : TRIPLE ANTIBIOTIC OINTMENT
Dosage Form : OINTMENT
Dosage Strength : 500UNIT/G
Packaging : 15 G
Approval Date :
Application Number : 2246693
Regulatory Info : OTC
Registration Country : Canada
Regulatory Info : OTC
Registration Country : Canada
Brand Name : COMPLETE ANTIBIOTIC OINTMENT
Dosage Form : OINTMENT
Dosage Strength : 500UNIT/G
Packaging : 15G
Approval Date :
Application Number : 2304465
Regulatory Info : OTC
Registration Country : Canada
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Cicatrin Powder 15g
Dosage Form : PDR
Dosage Strength : 250u
Packaging : 15X1u
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Cicatrin Powder 15G
Dosage Form : POR
Dosage Strength : 250u/g
Packaging : 15X1u/g
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
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PharmaCompass offers a list of Bacitracin Zinc 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 Bacitracin Zinc manufacturer or Bacitracin Zinc supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Bacitracin Zinc manufacturer or Bacitracin Zinc supplier.
PharmaCompass also assists you with knowing the Bacitracin Zinc API Price utilized in the formulation of products. Bacitracin Zinc API Price is not always fixed or binding as the Bacitracin Zinc Price is obtained through a variety of data sources. The Bacitracin Zinc Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, including repackagers and relabelers. The FDA regulates NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. NEOMYCIN AND POLYMYXIN B SULFATES AND 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 NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC supplier is an individual or a company that provides NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC active pharmaceutical ingredient (API) or NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC finished formulations upon request. The NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC suppliers may include NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC API manufacturers, exporters, distributors and traders.
click here to find a list of NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC DMF (Drug Master File) is a document detailing the whole manufacturing process of NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC active pharmaceutical ingredient (API) in detail. Different forms of NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC DMFs exist exist since differing nations have different regulations, such as NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC DMF submitted to regulatory agencies in the US is known as a USDMF. NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC USDMF includes data on NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC 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 NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC Drug Master File in Japan (NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC JDMF) empowers NEOMYCIN AND POLYMYXIN B SULFATES AND 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 NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC JDMF during the approval evaluation for pharmaceutical products. At the time of NEOMYCIN AND POLYMYXIN B SULFATES AND 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 NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC suppliers with JDMF on PharmaCompass.
A NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC CEP of the European Pharmacopoeia monograph is often referred to as a NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC Certificate of Suitability (COS). The purpose of a NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC to their clients by showing that a NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC CEP has been issued for it. The manufacturer submits a NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC CEP (COS) as part of the market authorization procedure, and it takes on the role of a NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC CEP holder for the record. Additionally, the data presented in the NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC DMF.
A NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. NEOMYCIN AND POLYMYXIN B SULFATES AND 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 NEOMYCIN AND POLYMYXIN B SULFATES AND 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 NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for NEOMYCIN AND POLYMYXIN B SULFATES AND 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 NEOMYCIN AND POLYMYXIN B SULFATES AND 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 NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC suppliers with NDC on PharmaCompass.
NEOMYCIN AND POLYMYXIN B SULFATES AND 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 NEOMYCIN AND POLYMYXIN B SULFATES AND 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 NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC GMP manufacturer or NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC GMP API supplier for your needs.
A NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC CoA (Certificate of Analysis) is a formal document that attests to NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC's compliance with NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC specifications and serves as a tool for batch-level quality control.
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC CoA mostly includes findings from lab analyses of a specific batch. For each NEOMYCIN AND POLYMYXIN B SULFATES AND 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.
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC may be tested according to a variety of international standards, such as European Pharmacopoeia (NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC EP), NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC JP (Japanese Pharmacopeia) and the US Pharmacopoeia (NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC USP).