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

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ACTIVE PHARMA INGREDIENTS

39 API Suppliers, 18 USDMF, 16 CEP/COS, 6 JDMF, 4 EU WC, 4 KDMF, 4 NDC API, 14 Listed Suppliers, $ API Reference Price

39 API Suppliers
18 USDMF
16 CEP/COS
6 JDMF
4 EU WC
4 KDMF
4 NDC API
14 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

INTERMEDIATES

6 Intermediates Suppliers

6 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

221 FDF Dossiers, 42 FDA Orange Book, 100 Europe, 6 Canada, 16 South Africa, 57 Listed Dossiers

221 FDF Dossiers
42 FDA Orange Book
100 Europe
6 Canada
16 South Africa
57 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

POWDER;INTRAVENOUS - EQ 0.5GM BASE;2GM/VIAL, INJECTABLE;INJECTION - 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 6GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 20MG BASE/ML, INJECTABLE;INJECTION - EQ 40MG BASE/ML, INJECTABLE;INJECTION - EQ 1GM BASE, INJECTABLE;INJECTION - EQ 2GM BASE

drugProductComposition
POWDER;INTRAVENOUS - EQ 0.5GM BASE;2GM/VIAL
INJECTABLE;INJECTION - 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE;INJECTION - 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE;INJECTION - 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE;INJECTION - 6GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE;INJECTION - EQ 20MG BASE/ML
INJECTABLE;INJECTION - EQ 40MG BASE/ML
INJECTABLE;INJECTION - EQ 1GM BASE
INJECTABLE;INJECTION - EQ 2GM BASE

RELATED EXCIPIENT COMPANIES

1 Actylis, 1 Kerry, 1 Microlex e.U, 1 Pluviaendo, 1 Roquette

relatedExcipients
1 Actylis
1 Kerry
1 Microlex e.U
1 Pluviaendo
1 Roquette

EXCIPIENTS BY APPLICATIONS

2 Parenteral, 2 Fillers, Diluents & Binders, 1 Co-Processed Excipients, 1 Taste Masking

excipientsByApplications
2 Parenteral
2 Fillers, Diluents & Binders
1 Co-Processed Excipients
1 Taste Masking

DIGITAL CONTENT

4 DATA COMPILATION #PharmaFlow, 25 NEWS #PharmaBuzz

media
4 DATA COMPILATION #PharmaFlow
25 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 82 Finished Drug Prices, 8 Annual Reports

globalSalesInformation
3 US Medicaid Prescriptions
82 Finished Drug Prices
8 Annual Reports

MARKET PLACE

21 APIs, 20 FDF Dossiers

marketPlace
21 APIs
20 FDF Dossiers

PATENTS & EXCLUSIVITIES

10 US Patents, 4 US Exclusivities, 16 Health Canada Patents

patents
10 US Patents
4 US Exclusivities
16 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM , 2 USP , 4 Others

otherSolutions
2 EDQM
2 USP
4 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 374

MARKET PLACE

API

FDF

6INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

221

FDF Dossiers

FDA Orange Book

100

Europe

Canada

Australia

South Africa

Listed Dossiers

3DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

14,255,398

Annual Reports (USD Million)

1,857

Finished Drug Prices

5 RELATED EXCIPIENT COMPANIES

6EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 72558-82-8, Tazidime, Fortaz, Ceftazidime anhydrous, Pentacef, Tazicef

Molecular Formula

C₂₂H₂₂N₆O₇S₂

Molecular Weight

546.6 g/mol

InChI Key

ORFOPKXBNMVMKC-DWVKKRMSSA-N

Semisynthetic, broad-spectrum antibacterial derived from CEPHALORIDINE and used especially for Pseudomonas and other gram-negative infections in debilitated patients.

1 2D Structure

Ceftazidime

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(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

2.1.2 InChI

InChI=1S/C22H22N6O7S2/c1-22(2,20(33)34)35-26-13(12-10-37-21(23)24-12)16(29)25-14-17(30)28-15(19(31)32)11(9-36-18(14)28)8-27-6-4-3-5-7-27/h3-7,10,14,18H,8-9H2,1-2H3,(H4-,23,24,25,29,31,32,33,34)/b26-13-/t14-,18-/m1/s1

2.1.3 InChI Key

ORFOPKXBNMVMKC-DWVKKRMSSA-N

2.1.4 Canonical SMILES

CC(C)(C(=O)O)ON=C(C1=CSC(=N1)N)C(=O)NC2C3N(C2=O)C(=C(CS3)C[N+]4=CC=CC=C4)C(=O)[O-]

2.1.5 Isomeric SMILES

CC(C)(C(=O)O)O/N=C(/C1=CSC(=N1)N)\C(=O)N[C@H]2[C@@H]3N(C2=O)C(=C(CS3)C[N+]4=CC=CC=C4)C(=O)[O-]

2.2 Synonyms

2.2.1 MeSH Synonyms

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

2.2.2 Depositor-Supplied Synonyms

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

2.3 Create Date

2005-08-01

3 Chemical and Physical Properties

Molecular Formula	C₂₂H₂₂N₆O₇S₂
Molecular Weight	546.6 g/mol
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 Å²
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

4 Drug and Medication Information

4.1 Drug Information

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

4.2 Drug Indication

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

5 Pharmacology and Biochemistry

5.1 Pharmacology

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.

5.2 MeSH Pharmacological Classification

Anti-Bacterial Agents

Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)

5.3 FDA Pharmacological Classification

5.3.1 Pharmacological Classes

Cephalosporins [CS]; Cephalosporin Antibacterial [EPC]

5.4 ATC Code

J - Antiinfectives for systemic use

J01 - Antibacterials for systemic use

J01D - Other beta-lactam antibacterials

J01DD - Third-generation cephalosporins

J01DD02 - Ceftazidime

5.5 Absorption, Distribution and Excretion

Absorption

Ceftazidime administered intravenously in healthy males produced mean C_max 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 C_max 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 C_max 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.

5.6 Metabolism/Metabolites

Ceftazidime is not appreciably metabolized.

5.7 Biological Half-Life

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.

5.8 Mechanism of Action

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

01

HRV Global Life Sciences

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM

Not Confirmed

HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

Contact Supplier

India

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF AU, ASMF

AUDIT

02

Orchid Pharma

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM

Not Confirmed

03

Orchid Pharma

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM

Not Confirmed

04

Sandoz B2B

Switzerland

South Korea

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM

Not Confirmed

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USDMF

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Acs Dobfar Spa

Italy

Duphat

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Acs Dobfar Spa

Switzerland

Duphat

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CEP/COS

01

AUROBINDO PHARMA LIMITED Hyderabad ...

India

Duphat

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02

FRESENIUS KABI IPSUM S.R.L. Cassina...

Italy

Duphat

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03

GlaxoSmithKline Research & Developm...

United Kingdom

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API Reference Price

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SQUARE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731436200,"product":"CEFTAZIDIME FOR INJECTION (BULK STERILE) IP (105 CTN) IUPACNAME: (6R,7R)-7-[[(2E)-2-(2-AMINO-1,3-THIAZOL-4-YL)-2-(1-HYDCEFTAZIDIME FOR INJECTION (BULK STERILE) IP (105 CTN) IUPAC","address":"305 AGGARWAL CITY SQUARE","city":"DELHI","supplier":"LONGCHEM INTERNATIONALTRADING COMPANY LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"SHAH TC DISTRIBUTION LLP","customerCountry":"INDIA","quantity":"560.00","actualQuantity":"560","unit":"KGS","unitRateFc":"196","totalValueFC":"110815.9","currency":"USD","unitRateINR":"16699.2","date":"13-Nov-2024","totalValueINR":"9351552","totalValueInUsd":"110815.9","indian_port":"JNPT SEZ\/MUMBAI","hs_no":"29419090","bill_no":"6655543","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Sterile","supplierPort":"SHANGHAI","supplierAddress":"UNIT 2 OF LG 1, MIRROR TOWER, 61 MO DY ROAD, TSIM SHA TSUI, KOWLOON HON G KONG Kowloon, , HONG KONG HONG KONG","customerAddress":"305 AGGARWAL CITY SQUARE"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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Drugs in Development

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INTERMEDIATES SUPPLIERS

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FDF Dossiers

01

AbbVie Inc

U.S.A

Biotech Showcase

Not Confirmed

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Contact Supplier

U.S.A

Virtual Booth

Digital Content

Regulatory Info : RX

Registration Country : USA

AVIBACTAM SODIUM; CEFTAZIDIME

Brand Name : AVYCAZ

Dosage Form : POWDER;INTRAVENOUS

Dosage Strength : EQ 0.5GM BASE;2GM/VIAL

Packaging :

Approval Date : 2015-02-25

Application Number : 206494

Regulatory Info : RX

Registration Country : USA

Product Web Link

Corporate PDF

02

Towa Pharmaceutical

Japan

Biotech Showcase

Not Confirmed

Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.

Contact Supplier

Japan

Virtual Booth

Digital Content

Regulatory Info :

Registration Country : Italy

Ceftazidime

Brand Name : CEFTAZIDIME THINK

Dosage Form : Powder And Solvent For Injection

Dosage Strength : 1 g/3 ml

Packaging : 1 UNIT 1000 MG - PARENTERAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

Portfolio PDF

Product Web Link

03

ACS DOBFAR SPA

Italy

Biotech Showcase

Not Confirmed

04

Ananta Medicare

United Kingdom

Biotech Showcase

Not Confirmed

05

Fresenius SE & Co. KGaA

Germany

U.S.A

Biotech Showcase

Not Confirmed

09

Jodas Expoim Pvt. Ltd

India

Biotech Showcase

Not Confirmed

10

Stragen Pharma SA

Switzerland

Biotech Showcase

Not Confirmed

Only 10 entries up to this point, click to access all

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FDA Orange Book

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Europe

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Canada

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South Africa

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Listed Dossiers

01

ACS DOBFAR SPA

Italy

BIO Partnering at JPM

Not Confirmed

02

Antibiotice SA

Romania

BIO Partnering at JPM

Not Confirmed

03

Aurobindo Pharma Limited

BIO Partnering at JPM

Not Confirmed

07

Orofino Pharmaceuticals Group

Italy

China

BIO Partnering at JPM

Not Confirmed

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DRUG PRODUCT COMPOSITIONS

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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

Related Excipient Companies

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Excipients by Applications

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Parenteral

Fillers, Diluents & Binders

Co-Processed Excipients

Taste Masking

Digital Content

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DATA COMPILATION #PharmaFlow

NEWS #PharmaBuzz

Global Sales Information

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US Medicaid Prescriptions

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Finished Drug Prices

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Annual Reports

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Market Place

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APIs

Injectable Grade Ceftazidime (2 kg) API needed in Mexico [ENA21485]

A pharmaceutical company that focuses on the development, manufacturing, marketing and distribution of generic drugs, primarily prescription, OTC, medical devices, and cosmetics is looking for suppliers of Injectable Grade Ceftazidime (2 kg) API for development purposes. The suppliers must support this enquiry with DMF, GMP & CoA.

20 Dec 2024

Sterile & USP Grade Ceftazidime (40 kg) API needed in Sri Lanka [ENA20746]

A company that focuses on the development and manufacturing of solid dosage forms, oral liquids and parenteral is looking for suppliers of Sterile & USP Grade Ceftazidime (40 kg) API for commercial purposes. The suppliers must support this enquiry with CoA.

04 Oct 2024

Ceftazidime API needed in India [ENA20732]

A company that focuses on formulation & analytical development is looking for suppliers of Ceftazidime API for development purposes. The suppliers must support this enquiry with CEP and CoA.

03 Oct 2024

Ceftazidime + Avibactam API needed in Pakistan [ENA19947]

A company that focuses on manufacturing and distribution of various finished formulation is looking for suppliers of Ceftazidime + Avibactam API for development purposes. The ratio is 4:1. The suppliers must support this enquiry with GMP & CoA.

12 Jul 2024

Various APIs needed in Saudi Arabia [ENA16206]

A company that specializes in the development and marketing of innovative healthcare products is looking for suppliers of Various APIs. The suppliers must support this enquiry with DMF & GMP. 1. Ceftazidime API. The required quantity is 5 kg - 10 kg each for the pilot and later 300 kg - 500 kg/ annum for commercial purposes. 2. Avibactam API. The required quantity is 5 kg - 10 kg for the pilot batch.

25 Jan 2023

Various APIs needed in India [ENA15233]

A leading Indian pharmaceutical company that focuses on research, development, manufacturing and exporting a wide range of finished formulations is looking for suppliers of Various APIs for commercial purpose. The suppliers must support this enquiry with DMF. 1. Amoxicillin Trihydrate Powder (1150 kg) API 2. Lactulose (600 kg) API 3. Prednisolone Acetate (5 kg) API 4. Sterile Grade Cefuroxime Sodium (20 kg) API 5. Ceftazidime (10 kg) API

07 Oct 2022

Various API Blends needed in Egypt [ENA14842]

A company operating in the pharmaceutical field for the development, manufacturing, marketing, distribution and export of a comprehensive array of branded and generic drugs is looking for suppliers of Various API Blends for evaluation purpose. The suppliers must support this enquiry with GMP & CoA. 1. Ceftazidime + Avibactam API Blend 2. Imipenem + Cilastatin + Relebactam API Blend 3. Meropenem + Vaborbactam API Blend 4. Panipenem + Betamipron API Blend

29 Aug 2022

Various APIs needed in Pakistan [ENA13420]

A pharmaceutical company that specializes in the manufacturing of various finished formulations is looking for suppliers of Various APIs for development purpose. The required quantity is MOQ for each. The suppliers must support this enquiry with CoA. 1. Avibactam API 2. Bempedoic Acid API 3. Ceftazidime API

25 Apr 2022

Various APIs needed in India [ENA12701]

A company that deals in various pharmaceutical products like injections, syrups & hygiene products is looking for suppliers of Various APIs for commercial purpose. The suppliers must support this enquiry with CoA. 1. Ilaprazole (25 kg & 200 kg) API 2. Sterile Grade Ceftriaxone Sodium (50 kg) API 3. Sterile Grade Sulbactam Sodium (20 kg) API 4. Sterile Grade Tazobactam Sodium (2 kg) API 5. Sterile Grade Cefuroxime Sodium (20 kg) API 6. Sterile Grade Ceftazidime Sodium (10 kg) API 7. Sterile Grade Piperacillin and Tazobactam (50 kg) API 8. Sterile Grade Cefoperazone Sodium (10 kg) API

14 Feb 2022

Various APIs needed in Egypt [ENA12255]

A company that deals in the distribution of various pharmaceutical products is looking for suppliers of Various APIs for parenteral formulations. The suppliers must support this enquiry with DMF, GMP & CoA. 1. Ceftaroline Fosamil API 2. Ceftazidime + Avibactam API

29 Dec 2021

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FDF DOSSIERS

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Patents & EXCLUSIVITIES

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US Patents

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US Exclusivities

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REF. STANDARDS & IMPURITIES

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EDQM

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USP

Others

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ABOUT THIS PAGE

AVYCAZ Manufacturers

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

AVYCAZ Suppliers

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

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

AVYCAZ USDMF

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

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

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

AVYCAZ JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

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

AVYCAZ KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

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

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

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

AVYCAZ CEP

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

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

AVYCAZ WC

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

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

AVYCAZ NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing AVYCAZ as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for AVYCAZ API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture AVYCAZ as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain AVYCAZ and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a AVYCAZ NDC to their finished compounded human drug products, they may choose to do so.

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

AVYCAZ GMP

AVYCAZ 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 AVYCAZ 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 AVYCAZ GMP manufacturer or AVYCAZ GMP API supplier for your needs.

AVYCAZ CoA

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

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

AVYCAZ may be tested according to a variety of international standards, such as European Pharmacopoeia (AVYCAZ EP), AVYCAZ JP (Japanese Pharmacopeia) and the US Pharmacopoeia (AVYCAZ USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

39 API Suppliers

18 USDMF

16 CEP/COS

6 JDMF

4 EU WC

4 KDMF

4 NDC API

14 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

3 Drugs in Development

INTERMEDIATES

6 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

221 FDF Dossiers

42 FDA Orange Book

100 Europe

6 Canada

16 South Africa

57 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

POWDER;INTRAVENOUS - EQ 0.5GM BASE;2GM/VIAL

INJECTABLE;INJECTION - 1GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - 2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - 6GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - EQ 20MG BASE/ML

INJECTABLE;INJECTION - EQ 40MG BASE/ML

INJECTABLE;INJECTION - EQ 1GM BASE

INJECTABLE;INJECTION - EQ 2GM BASE

RELATED EXCIPIENT COMPANIES

1 Actylis

1 Kerry

1 Microlex e.U

1 Pluviaendo

1 Roquette

EXCIPIENTS BY APPLICATIONS

2 Parenteral

2 Fillers, Diluents & Binders

1 Co-Processed Excipients

1 Taste Masking

DIGITAL CONTENT

4 DATA COMPILATION #PharmaFlow

25 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions

82 Finished Drug Prices

8 Annual Reports

MARKET PLACE

21 APIs

20 FDF Dossiers

PATENTS & EXCLUSIVITIES

10 US Patents

4 US Exclusivities

16 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM

2 USP

4 Others

ACTIVE PHARMA INGREDIENTS

API REF. PRICE (USD/KG)

$ 374

MARKET PLACE

FINISHED DOSAGE FORMULATIONS

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

PATENTS & EXCLUSIVITIES

DIGITAL CONTENT

GLOBAL SALES INFORMATION

6EXCIPIENTS BY APPLICATIONS

01

02

03

04

INJECTABLE;INJECTION - 1GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

INJECTABLE;INJECTION - 2GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

INJECTABLE;INJECTION - 500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

INJECTABLE;INJECTION - 6GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons