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1. Ceftazidime Anhydrous
2. Ceftazidime Pentahydrate
3. Fortaz
4. Fortum
5. Gr 20263
6. Gr-20263
7. Gr20263
8. Ly 139381
9. Ly-139381
10. Ly139381
11. Pyridinium, 1-((7-(((2-amino-4-thiazolyl)((1-carboxy-1-methylethoxy)imino)acetyl)amino)-2-carboxy-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-en-3-yl)methyl)-, Inner Salt, Pentahydrate, (6r-(6alpha,7beta(z)))-
12. Tazidime
1. 72558-82-8
2. Tazidime
3. Fortaz
4. Ceftazidime Anhydrous
5. Pentacef
6. Tazicef
7. Ceptaz
8. Ceftazidima
9. Ceftazidimum
10. Ceftazidime Pentahydrate
11. Gr 20263
12. Chebi:3508
13. (6r,7r)-7-[[(2z)-2-(2-amino-1,3-thiazol-4-yl)-2-(2-carboxypropan-2-yloxyimino)acetyl]amino]-8-oxo-3-(pyridin-1-ium-1-ylmethyl)-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
14. Fortaz (tn)
15. (6r,7r)-7-[[2-(2-amino-1,3-thiazol-4-yl)-2-(2-carboxypropan-2-yloxyimino)acetyl]amino]-8-oxo-3-(pyridin-1-ium-1-ylmethyl)-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
16. 7-[[(2e)-2-(2-amino-1,3-thiazol-4-yl)-2-(2-carboxypropan-2-yloxyimino)acetyl]amino]-8-oxo-3-(pyridin-1-ium-1-ylmethyl)-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
17. Gr-20263
18. Ly-139381
19. 78439-06-2
20. Caz
21. J01dd07
22. Nsc-759260
23. Ceftazidime (tn)
24. Ceptaz (tn)
25. Schembl36849
26. Bidd:gt0734
27. Chembl44354
28. Dtxsid5022770
29. Hms2090m13
30. (6r,7r)-7-{[(2z)-2-(2-amino-1,3-thiazol-4-yl)-2-{[(2-carboxypropan-2-yl)oxy]imino}acetyl]amino}-8-oxo-3-(pyridinium-1-ylmethyl)-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
31. Hy-b0593
32. Bdbm50420259
33. Akos015951273
34. Ccg-269983
35. Db00438
36. Ncgc00179584-05
37. Ceftazidime (arginine Formulation)
38. Ab00513848
39. C06889
40. D07654
41. Ab00513848-02
42. Cefprozil, Antibiotic For Culture Media Use Only
43. A839420
44. Q-200811
45. (6r,7r)-7-((z)-2-(2-aminothiazol-4-yl)-2-(((2-carboxypropan-2-yl)oxy)imino)acetamido)-8-oxo-3-(pyridin-1-ium-1-ylmethyl)-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate (contains Ca. 10% Na2co3)
46. (6r,7r)-7-((z)-2-(2-aminothiazol-4-yl)-2-(((2-carboxypropan-2-yl)oxy)imino)acetamido)-8-oxo-3-(pyridin-1-ium-1-ylmethyl)-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate(containsca.10%na2co3)
47. (6r,7r)-7-({(2z)-2-(2-amino-1,3-thiazol-4-yl)-2-[(1-carboxy-1-methylethoxy)imino]acetyl}amino)-8-oxo-3-(pyridinium-1-ylmethyl)-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
48. 1-{[(6r,7r)-7-[(2z)-2-(2-amino-1,3-thiazol-4-yl)-2-[(1-carboxy-1-methylethoxy)imino]acetamido]-2-carboxylato-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl}pyridin-1-ium
49. 7beta-{[(2z)-2-(2-amino-1,3-thiazol-4-yl)-2-{[(2-carboxypropan-2-yl)oxy]imino}acetyl]amino}-3-(pyridinium-1-ylmethyl)-3,4-didehydrocepham-4-carboxylate
| Molecular Weight | 546.6 g/mol |
|---|---|
| Molecular Formula | C22H22N6O7S2 |
| XLogP3 | 0.4 |
| Hydrogen Bond Donor Count | 3 |
| Hydrogen Bond Acceptor Count | 12 |
| Rotatable Bond Count | 8 |
| Exact Mass | 546.09913941 g/mol |
| Monoisotopic Mass | 546.09913941 g/mol |
| Topological Polar Surface Area | 245 Ų |
| Heavy Atom Count | 37 |
| Formal Charge | 0 |
| Complexity | 1020 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 2 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 1 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
| 1 of 8 | |
|---|---|
| Drug Name | Ceftazidime |
| PubMed Health | Ceftazidime (Injection) |
| Drug Classes | Antibiotic |
| Drug Label | Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibiotic for parenteral administration. It isthe pentahydrate of pyridinium, 1-[[7-[[(2-amino-4-thiazolyl)[(1-carboxy-1-methylethoxy) imino] acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabic... |
| Active Ingredient | Ceftazidime |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 500mg/vial; 2gm/vial; 1gm/vial; 6gm/vial |
| Market Status | Prescription |
| Company | Wockhardt; Acs Dobfar |
| 2 of 8 | |
|---|---|
| Drug Name | Fortaz |
| PubMed Health | Ceftazidime (Injection) |
| Drug Classes | Antibiotic |
| Drug Label | Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibiotic for parenteral administration. It is the pentahydrate of pyridinium, 1-[[7-[[(2-amino-4-thiazolyl)[(1-carboxy-1-methylethoxy)imino]acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicycl... |
| Active Ingredient | Ceftazidime |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 500mg/vial; 2gm/vial; 1gm/vial; 6gm/vial |
| Market Status | Prescription |
| Company | Covis Injectables |
| 3 of 8 | |
|---|---|
| Drug Name | Fortaz in plastic container |
| PubMed Health | Ceftazidime (Injection) |
| Drug Classes | Antibiotic |
| Drug Label | Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibiotic for parenteral administration. It is the pentahydrate of pyridinium, 1-[[7-[[(2-amino-4-thiazolyl)[(1-carboxy-1-methylethoxy)imino]acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicycl... |
| Active Ingredient | Ceftazidime sodium |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 40mg base/ml; eq 20mg base/ml |
| Market Status | Prescription |
| Company | Covis Injectables |
| 4 of 8 | |
|---|---|
| Drug Name | Tazicef |
| Active Ingredient | Ceftazidime |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 500mg/vial; 2gm/vial; 1gm/vial; 6gm/vial |
| Market Status | Prescription |
| Company | Hospira |
| 5 of 8 | |
|---|---|
| Drug Name | Ceftazidime |
| PubMed Health | Ceftazidime (Injection) |
| Drug Classes | Antibiotic |
| Drug Label | Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibiotic for parenteral administration. It isthe pentahydrate of pyridinium, 1-[[7-[[(2-amino-4-thiazolyl)[(1-carboxy-1-methylethoxy) imino] acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabic... |
| Active Ingredient | Ceftazidime |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 500mg/vial; 2gm/vial; 1gm/vial; 6gm/vial |
| Market Status | Prescription |
| Company | Wockhardt; Acs Dobfar |
| 6 of 8 | |
|---|---|
| Drug Name | Fortaz |
| PubMed Health | Ceftazidime (Injection) |
| Drug Classes | Antibiotic |
| Drug Label | Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibiotic for parenteral administration. It is the pentahydrate of pyridinium, 1-[[7-[[(2-amino-4-thiazolyl)[(1-carboxy-1-methylethoxy)imino]acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicycl... |
| Active Ingredient | Ceftazidime |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 500mg/vial; 2gm/vial; 1gm/vial; 6gm/vial |
| Market Status | Prescription |
| Company | Covis Injectables |
| 7 of 8 | |
|---|---|
| Drug Name | Fortaz in plastic container |
| PubMed Health | Ceftazidime (Injection) |
| Drug Classes | Antibiotic |
| Drug Label | Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibiotic for parenteral administration. It is the pentahydrate of pyridinium, 1-[[7-[[(2-amino-4-thiazolyl)[(1-carboxy-1-methylethoxy)imino]acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicycl... |
| Active Ingredient | Ceftazidime sodium |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 40mg base/ml; eq 20mg base/ml |
| Market Status | Prescription |
| Company | Covis Injectables |
| 8 of 8 | |
|---|---|
| Drug Name | Tazicef |
| Active Ingredient | Ceftazidime |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 500mg/vial; 2gm/vial; 1gm/vial; 6gm/vial |
| Market Status | Prescription |
| Company | Hospira |
Ceftazidime is indicated for the treatment of lower respiratory tract infections, skin and skin structure infections, urinary tract infections, bacterial septicemia, bone and joint infections, gynecologic infections, intra-abdominal infections (including peritonitis), and central nervous system infections (including meningitis) caused by susceptible bacteria. Ceftazidime is indicated in combination with [avibactam] to treat infections caused by susceptible Gram-negative organisms, including complicated intra-abdominal infections (cIAI), in conjunction with [metronidazole], and complicated urinary tract infections (cUTI), including pyelonephritis, in patients aged three months and older. This combination is also indicated to treat hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) in patients aged 18 years and older. In all cases, to mitigate the risk of bacterial resistance and preserve clinical efficacy, ceftazidime should only be used for infections that are confirmed or strongly suspected to be caused by susceptible bacterial strains.
FDA Label
Ceftazidime is a semisynthetic, broad-spectrum, third-generation cephalosporin antibiotic that is bactericidal through inhibition of enzymes responsible for cell-wall synthesis, primarily penicillin-binding protein 3 (PBP3). Among cephalosporins, ceftazidime is notable for its resistance to numerous -lactamases and its broad spectrum of activity against Gram-negative bacteria, including _Pseudomonas aeruginosa_. However, it is less active than first- and second-generation cephalosporins against _Staphylococcus aureus_ and other Gram-positive bacteria and also has low activity against anaerobes. Ceftazidime has confirmed activity against clinically relevant Gram-negative bacteria including _Citrobacter_ spp., _Enterobacter_ spp., _Klebsiella_ spp., _Proteus_ spp., _Serratia spp., _Escherichia coli_, _Haemophilus influenzae_, _Neisseria meningitidis_, _Pseudomonas aeruginosa_, and some Gram-positive bacteria including _Staphylococcus_ spp. and _Streptococcus_ spp. There are also _in vitro_ data for ceftazidime efficacy against a wide variety of other bacteria, such as _Acinetobacter baumannii_ and _Neisseria gonorrhoeae_, but no clear clinical studies to support the use of ceftazidime for infections caused by these bacteria. Although -lactam antibiotics like ceftazidime are generally well tolerated, there remains a risk of serious acute hypersensitivity reactions, which is higher in patients with a known allergy to ceftazidime or any other -lactam antibiotic. As with all antibiotics, ceftazidime may result in the overgrowth of non-susceptible organisms and potentially serious effects including _Clostridium difficile_-associated diarrhea (CDAD); CDAD should be considered in patients who develop diarrhea and, in confirmed cases, supportive care initiated immediately. Ceftazidime is primarily renally excreted such that high and prolonged serum concentrations can occur in patients with renal insufficiency, leading to seizures, nonconvulsive status epilepticus (NCSE), encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia. Treatment may lead to the development or induction of resistance with a risk of treatment failure. Periodic susceptibility testing should be considered, and monotherapy failure may necessitate the addition of another antibiotic such as an aminoglycoside. Cephalosporin use may decrease prothrombin activity, which may be improved by exogenous vitamin K. Inadvertent intra-arterial administration of ceftazidime may result in distal necrosis.
Anti-Bacterial Agents
Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)
J - Antiinfectives for systemic use
J01 - Antibacterials for systemic use
J01D - Other beta-lactam antibacterials
J01DD - Third-generation cephalosporins
J01DD02 - Ceftazidime
Absorption
Ceftazidime administered intravenously in healthy males produced mean Cmax values of between 42 and 170 g/mL for doses between 500 mg and 2 g, and are reached immediately following the end of the infusion period. The Cmax for 1 g of ceftazidime administered intramuscularly is attained approximately one hour following injection and is between 37 and 43 mg/L. Following intramuscular administration of 500 mg and 1 g of ceftazidime, the serum concentration remained above 4 g/mL for six and eight hours, respectively. Ceftazidime Cmax and AUC show linear proportionality to the dose over the therapeutic range. In individuals with normal renal function, ceftazidime given intravenously every eight hours for 10 days as either 1 or 2 g doses showed no accumulation.
Route of Elimination
Approximately 80% to 90% of an intramuscular or intravenous dose of ceftazidime is excreted unchanged by the kidneys over a 24-hour period. When administered intravenously, 50% of the dose appears in the urine within two hours, with another 32% of the dose appearing by eight hours post-administration.
Volume of Distribution
Ceftazidime has a volume of distribution of 15-20 L.
Clearance
The mean renal clearance of ceftazidime in healthy subjects ranges from 72 to 141 mL/min while the calculated plasma clearance is approximately 115 mL/min.
Ceftazidime is not appreciably metabolized.
Ceftazidime has an elimination half-life of 1.5-2.8 hours in healthy subjects. As ceftazidime is primarily renally excreted, its half-life is significantly prolonged in patients with renal impairment. In patients with creatinine clearance < 12 mL/min, the half-life is prolonged to between 14 and 30 hours.
The bacterial cell wall, which is located at the periphery of Gram-positive bacteria and within the periplasm of Gram-negative bacteria, comprises a glycopeptide polymer synthesized through cross-linking of glycans to peptide stems on alternating saccharides, which is known commonly as peptidoglycan. Cell wall formation, recycling, and remodelling require numerous enzymes, including a family of enzymes with similar active site character despite distinct and sometimes overlapping roles as carboxypeptidases, endopeptidases, transpeptidases, and transglycosylases, known as "penicillin-binding proteins" (PBPs). The number of PBPs differs between bacteria, in which some are considered essential and others redundant. In general, inhibition of one or more essential PBPs results in impaired cell wall homeostasis, loss of cell integrity, and is ultimately bactericidal. Ceftazidime is a semisynthetic third-generation cephalosporin with broad activity against numerous Gram-negative and some Gram-positive bacteria. Like other -lactam antibiotics, ceftazidime exhibits its bactericidal effect primarily through direct inhibition of specific PBPs in susceptible bacteria. _In vitro_ experiments in Gram-negative bacteria such as _Escherichia coli_, _Pseudomonas aeruginosa_, _Acinetobacter baumannii_, and _Klebsiella pneumoniae_ suggest that ceftazidime primarily binds to PBP3, with weaker binding to PBP1a/1b and PBP2 as well; although binding to other PBPs, such as PBP4, is detectable, the concentrations required are much greater than those achieved clinically. Similarly, ceftazidime showed binding to _Staphylococcus aureus_ PBP 1, 2, and 3 with a much lower affinity for PBP4. Recent data for _Mycobacterium abcessus_ suggest that ceftazidime can inhibit PonA1, PonA2, and PbpA at intermediate concentrations.
API SUPPLIERS
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24787
Submission : 2011-03-22
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-12-10
Pay. Date : 2013-09-06
DMF Number : 20481
Submission : 2006-12-28
Status : Active
Type : II
Certificate Number : R1-CEP 2016-195 - Rev 00
Issue Date : 2022-11-10
Type : Chemical
Substance Number : 1405
Status : Valid
Registration Number : 302MF10077
Registrant's Address : No. 849 Dongjia Town, Licheng District, Jinan, Shandong, China
Initial Date of Registration : 2020-07-06
Latest Date of Registration :
NDC Package Code : 51810-006
Start Marketing Date : 2020-04-04
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 : 7115
Submission : 1987-08-24
Status : Active
Type : II
Certificate Number : R1-CEP 2001-252 - Rev 04
Issue Date : 2015-06-15
Type : Chemical
Substance Number : 1405
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13009
Submission : 1998-05-25
Status : Active
Type : II
Certificate Number : R1-CEP 2010-272 - Rev 01
Issue Date : 2019-05-03
Type : Chemical
Substance Number : 2344
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16082
Submission : 2002-08-06
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-02-29
Pay. Date : 2024-02-23
DMF Number : 23294
Submission : 2009-12-24
Status : Active
Type : II
Certificate Number : CEP 2005-028 - Rev 05
Issue Date : 2024-09-06
Type : Chemical
Substance Number : 1405
Status : Valid
Date of Issue : 2019-07-22
Valid Till : 2022-07-21
Written Confirmation Number : WC-0131
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39408
Submission : 2024-01-25
Status : Active
Type : II
Certificate Number : CEP 2009-234 - Rev 01
Issue Date : 2024-09-09
Type : Chemical
Substance Number : 2344
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16794
Submission : 2003-08-28
Status : Inactive
Type : II
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DOSAGE - POWDER;INTRAVENOUS - EQ 0.5GM BASE;2...DOSAGE - POWDER;INTRAVENOUS - EQ 0.5GM BASE;2GM/VIAL
USFDA APPLICATION NUMBER - 206494
DOSAGE - INJECTABLE;INJECTION - 1GM/VIAL **Fe...DOSAGE - INJECTABLE;INJECTION - 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50578
DOSAGE - INJECTABLE;INJECTION - 2GM/VIAL **Fe...DOSAGE - INJECTABLE;INJECTION - 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50578
DOSAGE - INJECTABLE;INJECTION - 500MG/VIAL **...DOSAGE - INJECTABLE;INJECTION - 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50578
DOSAGE - INJECTABLE;INJECTION - 6GM/VIAL **Fe...DOSAGE - INJECTABLE;INJECTION - 6GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50578
DOSAGE - INJECTABLE;INJECTION - EQ 20MG BASE/...DOSAGE - INJECTABLE;INJECTION - EQ 20MG BASE/ML
USFDA APPLICATION NUMBER - 50634
DOSAGE - INJECTABLE;INJECTION - EQ 40MG BASE/...DOSAGE - INJECTABLE;INJECTION - EQ 40MG BASE/ML
USFDA APPLICATION NUMBER - 50634
DOSAGE - INJECTABLE;INJECTION - EQ 1GM BASE
USFDA APPLICATION NUMBER - 50823
DOSAGE - INJECTABLE;INJECTION - EQ 2GM BASE
USFDA APPLICATION NUMBER - 50823
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PharmaCompass offers a list of Ceftazidime 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 Ceftazidime manufacturer or Ceftazidime supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ceftazidime manufacturer or Ceftazidime supplier.
PharmaCompass also assists you with knowing the Ceftazidime API Price utilized in the formulation of products. Ceftazidime API Price is not always fixed or binding as the Ceftazidime Price is obtained through a variety of data sources. The Ceftazidime Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ceftazidime Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ceftazidime Sodium, including repackagers and relabelers. The FDA regulates Ceftazidime Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ceftazidime Sodium 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 Ceftazidime Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ceftazidime Sodium supplier is an individual or a company that provides Ceftazidime Sodium active pharmaceutical ingredient (API) or Ceftazidime Sodium finished formulations upon request. The Ceftazidime Sodium suppliers may include Ceftazidime Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Ceftazidime Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ceftazidime Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Ceftazidime Sodium active pharmaceutical ingredient (API) in detail. Different forms of Ceftazidime Sodium DMFs exist exist since differing nations have different regulations, such as Ceftazidime Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ceftazidime Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Ceftazidime Sodium USDMF includes data on Ceftazidime Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ceftazidime Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ceftazidime Sodium 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 Ceftazidime Sodium Drug Master File in Japan (Ceftazidime Sodium JDMF) empowers Ceftazidime Sodium 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 Ceftazidime Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Ceftazidime Sodium 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 Ceftazidime Sodium suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Ceftazidime Sodium Drug Master File in Korea (Ceftazidime Sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ceftazidime Sodium. The MFDS reviews the Ceftazidime Sodium KDMF as part of the drug registration process and uses the information provided in the Ceftazidime Sodium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ceftazidime Sodium 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 Ceftazidime Sodium API can apply through the Korea Drug Master File (KDMF).
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A Ceftazidime Sodium CEP of the European Pharmacopoeia monograph is often referred to as a Ceftazidime Sodium Certificate of Suitability (COS). The purpose of a Ceftazidime Sodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ceftazidime Sodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ceftazidime Sodium to their clients by showing that a Ceftazidime Sodium CEP has been issued for it. The manufacturer submits a Ceftazidime Sodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ceftazidime Sodium CEP holder for the record. Additionally, the data presented in the Ceftazidime Sodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ceftazidime Sodium DMF.
A Ceftazidime Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ceftazidime Sodium CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A Ceftazidime Sodium written confirmation (Ceftazidime Sodium WC) is an official document issued by a regulatory agency to a Ceftazidime Sodium manufacturer, verifying that the manufacturing facility of a Ceftazidime Sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ceftazidime Sodium APIs or Ceftazidime Sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Ceftazidime Sodium WC (written confirmation) as part of the regulatory process.
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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 Ceftazidime Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ceftazidime Sodium 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 Ceftazidime Sodium 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 Ceftazidime Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ceftazidime Sodium NDC to their finished compounded human drug products, they may choose to do so.
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Ceftazidime Sodium 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 Ceftazidime Sodium 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 Ceftazidime Sodium GMP manufacturer or Ceftazidime Sodium GMP API supplier for your needs.
A Ceftazidime Sodium CoA (Certificate of Analysis) is a formal document that attests to Ceftazidime Sodium's compliance with Ceftazidime Sodium specifications and serves as a tool for batch-level quality control.
Ceftazidime Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Ceftazidime Sodium 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.
Ceftazidime Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Ceftazidime Sodium EP), Ceftazidime Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ceftazidime Sodium USP).
