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    Chemistry

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    Also known as: Omnicef, 91832-40-5, Cefzon, Cfdn, Cefdinirum, Ci-983
    Molecular Formula
    C14H13N5O5S2
    Molecular Weight
    395.4  g/mol
    InChI Key
    RTXOFQZKPXMALH-GHXIOONMSA-N
    FDA UNII
    CI0FAO63WC
    Cefdinir
    A third-generation oral cephalosporin antibacterial agent that is used to treat bacterial infections of the respiratory tract and skin.
    Cefdinir is a Cephalosporin Antibacterial.
    1 2D Structure

    Cefdinir

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (6R,7R)-7-[[(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-hydroxyiminoacetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
    2.1.2 InChI
    InChI=1S/C14H13N5O5S2/c1-2-5-3-25-12-8(11(21)19(12)9(5)13(22)23)17-10(20)7(18-24)6-4-26-14(15)16-6/h2,4,8,12,24H,1,3H2,(H2,15,16)(H,17,20)(H,22,23)/b18-7-/t8-,12-/m1/s1
    2.1.3 InChI Key
    RTXOFQZKPXMALH-GHXIOONMSA-N
    2.1.4 Canonical SMILES
    C=CC1=C(N2C(C(C2=O)NC(=O)C(=NO)C3=CSC(=N3)N)SC1)C(=O)O
    2.1.5 Isomeric SMILES
    C=CC1=C(N2[C@@H]([C@@H](C2=O)NC(=O)/C(=N\O)/C3=CSC(=N3)N)SC1)C(=O)O
    2.2 Other Identifiers
    2.2.1 UNII
    CI0FAO63WC
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 7-(2 (2-aminothiazol-4-yl)-2-hydroxyiminoacetamido)-3-vinyl-3-cephem-4-carboxylic Acid

    2. Ci 983

    3. Ci-983

    4. Ci983

    5. Fk 482

    6. Fk-482

    7. Fk482

    8. Omnicef

    9. Pd 134393

    10. Pd-134393

    2.3.2 Depositor-Supplied Synonyms

    1. Omnicef

    2. 91832-40-5

    3. Cefzon

    4. Cfdn

    5. Cefdinirum

    6. Ci-983

    7. Fk-482

    8. Fk 482

    9. Cefdinir Anhydrous

    10. Bmy-28488

    11. Cefdinir (omnicef)

    12. Chebi:3485

    13. Cefdinyl

    14. Ci0fao63wc

    15. (6r,7r)-7-[[(2z)-2-(2-amino-1,3-thiazol-4-yl)-2-hydroxyiminoacetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid

    16. Nsc-758926

    17. Cefdinir 100 Microg/ml In Acetonitrile

    18. Pd 134393

    19. Cefdirnir

    20. Cefdinirum [inn-latin]

    21. (6r,7r)-7-((z)-2-(2-aminothiazol-4-yl)-2-(hydroxyimino)acetamido)-8-oxo-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid

    22. (6r,7r)-7-[(2z)-2-(2-amino-1,3-thiazol-4-yl)-2-(n-hydroxyimino)acetamido]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid

    23. Ceftinex

    24. (e)-cefdinir

    25. Bmy 28488

    26. Ci 983

    27. (6r,7r)-7-{2-(2-amino-thiazol-4-yl)-2-[(z)-hydroxyimino]-acetylamino}-8-oxo-3-vinyl-5-thia-1-aza-bicyclo[4.2.0]oct-2-ene-2-carboxylic Acid

    28. (6r,7r,z)-7-(2-(2-aminothiazol-4-yl)-2-(hydroxyimino)acetamido)-8-oxo-3-vinyl-5-thia-1-aza-bicyclo[4.2.0]oct-2-ene-2-carboxylic Acid

    29. Omnicef (tn)

    30. Cefzon (tn)

    31. Pd-134393

    32. Sr-05000001991

    33. Unii-ci0fao63wc

    34. Cefdinir [usan:usp:inn:ban]

    35. Ci983

    36. Fk482

    37. Cefdinir, 97%

    38. (-)-(6r,7r)-7-(2-(2-amino-4-thiazolyl)glyoxylamido)-8-oxo-3-vinyl-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 7(sup 2)-(z)-oxime

    39. Fr-80482

    40. Cefdinir [usan]

    41. Cefdinir [inn]

    42. Cefdinir [jan]

    43. Cefdinir [mi]

    44. Cefdinir [vandf]

    45. Spectrum5_001560

    46. Cefdinir [mart.]

    47. Cefdinir [usp-rs]

    48. Cefdinir [who-dd]

    49. Chembl927

    50. Schembl36995

    51. Bspbio_002735

    52. Mls001304703

    53. Mls001424233

    54. Bidd:gt0827

    55. Spectrum1505208

    56. Cefdinir (jp17/usp/inn)

    57. Cefdinir [orange Book]

    58. Cefdinir [usp Monograph]

    59. Dtxsid8046084

    60. Cid_6915944

    61. Bcpp000293

    62. Hms1922l19

    63. Hms2093k20

    64. Hms3715f07

    65. Pharmakon1600-01505208

    66. Amy22139

    67. Hy-b0136

    68. Bdbm50248190

    69. Ccg-39455

    70. Mfcd00865030

    71. Nsc758926

    72. S1605

    73. Zinc13119676

    74. Akos015951262

    75. Akos032960348

    76. Bcp9000503

    77. Cs-1925

    78. Db00535

    79. Nsc 758926

    80. Ncgc00178499-01

    81. Ncgc00178499-02

    82. Ncgc00178499-08

    83. (6r,7r)-7-{[(2z)-2-(2-amino-1,3-thiazol-4-yl)-2-(hydroxyimino)acetyl]amino}-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid

    84. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 7-(((2-amino-4-thiazolyl) (hydroxyimino)acetyl)amino)-3-ethenyl-8-oxo-, (6r-(6alpha,7beta(z)))-

    85. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 7-(((2-amino-4-thiazolyl)(hydroxyiminoacetyl)amino)-3-ethenyl-8-oxo-, (6r-(6-alpha,7-beta(z)))-

    86. 5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid,7-[[(2z)-(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-, (6r,7r)-

    87. 7beta-[(2z)-2-(2-amino-1,3-thiazol-4-yl)-2-(hydroxyimino)acetamido]-3-ethenyl-3,4-didehydrocepham-4-carboxylic Acid

    88. As-35316

    89. Pd134393

    90. Sbi-0206739.p001

    91. C-2466

    92. C08110

    93. D00917

    94. Ab01274720-01

    95. Ab01274720_02

    96. Ab01274720_03

    97. Cefdinir, Antibiotic For Culture Media Use Only

    98. 832c405

    99. A844075

    100. Sr-05000001991-1

    101. Sr-05000001991-2

    102. Brd-k15766189-001-05-6

    103. Q27263344

    104. (-)-(6r,7r)-7-(2-(2-amino-4-thiazolyl)glyoxylamido)-8-oxo-3-vinyl-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 72-(z)-oxime

    105. (6r,7r)-7-(((2z)-(2-amino-4-thiazolyl)(hydroxyimino)acetyl)amino)-3-ethenyl-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid

    106. (6r,7r)-7-[[(2z)-2-(2-aminothiazol-4-yl)-2-hydroxyimino-acetyl]amino]-8-oxo-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid;cefdinir

    107. (7r)-3-vinyl-7-[[(2-amino-4-thiazolyl)[(e)-hydroxyimino]acetyl]amino]cepham-3-ene-4-carboxylic Acid

    108. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 7-(((2-amino-4-thiazolyl) (hydroxyimino)acetyl)amino)-3-ethenyl-8-oxo-, (6r-(6.alpha.,7.beta.(z)))-

    109. 5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid, 7-[[(2z)-2-(2-amino-4-thiazolyl)-2-(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-, (6r,7r)-

    110. Syn-7-(2-(2-amino-4-thiazolyl)-2-hydroxyiminoacetamido)-3-vinyl-3-cephem-4-carboxylic Acid

    2.4 Create Date
    2006-07-15
    3 Chemical and Physical Properties
    Molecular Weight 395.4 g/mol
    Molecular Formula C14H13N5O5S2
    XLogP30
    Hydrogen Bond Donor Count4
    Hydrogen Bond Acceptor Count10
    Rotatable Bond Count5
    Exact Mass395.03581088 g/mol
    Monoisotopic Mass395.03581088 g/mol
    Topological Polar Surface Area212 Ų
    Heavy Atom Count26
    Formal Charge0
    Complexity739
    Isotope Atom Count0
    Defined Atom Stereocenter Count2
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count1
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameCefdinir
    PubMed HealthCefdinir (By mouth)
    Drug ClassesAntibiotic
    Drug LabelCefdinir for oral suspension, USPcontains the active ingredient cefdinir USP, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir is [6R-[6,7 (Z)]]-7-[[(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino...
    Active IngredientCefdinir
    Dosage FormCapsule; For suspension
    RouteOral
    Strength300mg; 125mg/5ml; 250mg/5ml
    Market StatusPrescription
    CompanyTeva Pharms; Aurobindo Pharma; Lupin; Sandoz; Orchid Hlthcare

    2 of 2  
    Drug NameCefdinir
    PubMed HealthCefdinir (By mouth)
    Drug ClassesAntibiotic
    Drug LabelCefdinir for oral suspension, USPcontains the active ingredient cefdinir USP, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, cefdinir is [6R-[6,7 (Z)]]-7-[[(2-amino-4-thiazolyl)(hydroxyimino)acetyl]amino...
    Active IngredientCefdinir
    Dosage FormCapsule; For suspension
    RouteOral
    Strength300mg; 125mg/5ml; 250mg/5ml
    Market StatusPrescription
    CompanyTeva Pharms; Aurobindo Pharma; Lupin; Sandoz; Orchid Hlthcare

    4.2 Drug Indication

    Cefdinir is indicated to treat acute bacterial otitis media, acute maxillary sinusitis, community-acquired (CA) pneumonia, acute bacterial exacerbations of chronic bronchitis, pharyngitis/tonsillitis, and uncomplicated skin and skin structure infections in children and adults. The organisms susceptible to cefdinir have been listed below in addition to their associated clinical condition that may be treated with cefdinir. Various beta-lactamase producing organisms may be treated, as indicated in certain sections below. **Respiratory** Acute bacterial exacerbations of chronic bronchitis caused by Haemophilus influenzae, Haemophilus parainfluenzae, Streptococcus pneumoniae (penicillin-susceptible only), and Moraxella catarrhalis Community-acquired pneumonia caused by Haemophilus influenzae, Haemophilus parainfluenzae, Streptococcus pneumoniae (penicillin-susceptible only), and Moraxella catarrhalis **Ear, nose, and throat** Acute bacterial otitis media caused by Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumoniae (penicillin-susceptible only) Tonsillitis caused by Streptococcus pyogenes Pharyngitis caused by Streptococcus pyogenes Acute maxillary sinusitis caused by Haemophilus pneumoniae and Streptococcus pneumoniae (penicillin-susceptible only), and Moraxella catarrhalis **Skin and skin structure infections** Uncomplicated skin and skin structure infections caused by Staphylococcus aureus and Streptococcus pyogenes

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Cefdinir is a bactericidal agent that treats bacterial infections by interfering with cell wall synthesis. Cefdinir exerts broad-spectrum activity against a variety of gram-positive and gram-negative bacterial infections. It is effective against several beta-lactamase enzyme producing bacteria. As a result, many organisms that are resistant to other cephalosporins may be susceptible to cefdinir.

    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 Active Moiety
    CEFDINIR
    5.3.2 FDA UNII
    CI0FAO63WC
    5.3.3 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

    J01DD15 - Cefdinir

    5.5 Absorption, Distribution and Excretion

    Absorption

    Maximal plasma cefdinir concentration can be attained between 2-4 hours after an ingested dose. The bioavailability of cefdinir depends on the formulation used. The estimated bioavailability of cefdinir in the capsule form is approximately 16%-21%, depending on the dose. Absolute bioavailability after the administration of a suspension of cefdinir is 25%.. The Cmax of cefdinir is 1.60 g/mL after a 300 mg dose with an AUC of 7.05. Cmax is 2.87 g/mL after a 600 mg dose with an AUC of 11. A meal high in fat can reduce the absorption of cefdinir by up to 15%, however, this is not a cause for clinically significant changes, therefore cefdinir may be taken with or without food. When given with aluminum or magnesium-containing antacids or iron, cefdinir absorption may decrease. It is recommended to allow 2 hours between cefdinir administration and the administration of these agents.

    Route of Elimination

    This drug is mainly excreted by the kidneys. Dose adjustments may be required for patients with renal impairment or patients on dialysis. Approximately 18.4% of a 300 mg dose of cefdinir was found unchanged in the urine after a 300 mg dose was administered during a pharmacokinetic study of 21 individuals. A large proportion of the administered dose is excreted in the feces, although the majority is found in the urine.

    Volume of Distribution

    The average volume of distribution of cefdinir in adults is about 0.35 L/kg and 0.67 L/kg in children. Another resource estimates the volume of distribution in adults at 1.562.09 L/kg. Cefdinir is found to be distributed in various tissues at clinically effective concentrations. It may be found in the epithelial lining fluid, bronchial mucosa, tonsils, sinuses, skin blister fluid, as well as the middle ear fluid. Third-generation cephalosporins such as cefdinir cross the blood-brain barrier and are found in high concentrations in the cerebrospinal fluid, unlike their first and second generation counterparts. The wide tissue distribution of cefdinir allows it to treat a variety of infections throughout the body.

    Clearance

    The renal clearance in healthy adults in a pharmacokinetic study was 2.0 ( 1.0) mL/min/kg and the clearance in patients with renal failure was lower, decreasing in proportion to the degree of renal impairment. Dose adjustment is required in patients with renal impairment.

    5.6 Metabolism/Metabolites

    This drug is not significantly metabolized and its pharmacological actions are mainly attributed to the parent drug.

    5.7 Biological Half-Life

    The average plasma elimination half-life is about 1.7 hours in adults. In children and healthy infants, plasma elimination half-life ranges from 1.21.5 hours.

    5.8 Mechanism of Action

    Five-member thiazolidine rings that make up penicillins are replaced in cephalosporins by a six-member dihydrothiazine ring, conferring greater bactericidal activity. This This 6-member ring enables cefdinir and other cephalosporins to resist inactivation by certain bacterial enzymes. With a mechanism similar to other beta-lactam antibiotics, the bactericidal activity of cefdinir is caused by the inhibition of cell wall synthesis via binding to penicillin-binding proteins (PBPs). Cefdinir, like other cephalosporins, penetrates the bacterial cell wall, combats inactivation by beta-lactamase enzymes, and inactivates penicillin-binding proteins. This interferes with the final step of transpeptidation in cell walls, eventually leading to cell lysis, which eventually leads to the death of bacteria that are susceptible to this drug. Cefdinir has shown affinity to penicillin protein binding proteins 2 and 3. It has also been shown to inhibit transpeptidase enzymes of various bacteria, which may play a role in its bactericidal action. One in vitro study suggests that cefdinir inhibits myeloperoxidase release extracellularly. The impact of this potential drug target in relation to its mechanism of action is unknown.

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STATES","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"420","totalValueFC":"399585.7","currency":"USD","unitRateINR":33720.311000000002,"date":"22-Nov-2024","totalValueINR":"33720311","totalValueInUsd":"399585.7","indian_port":"Hyderabad Air","hs_no":"29419090","bill_no":"5830090","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"8-3-677\/18, S.K.D.NAGAR, HYDERABAD.AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732300200,"product":"CEFDINIR USP (MICRONIZED), BATCH NO. CDRM240041, MFG. DT. SEPTEMBER 2024 EXP. DT. AUGUST 2027","address":"D-3,MATRU-ASHISH,NR.BAL-BHARATI SCH","city":"MUMBAI","supplier":"YASHVI HEALTHCARE","supplierCountry":"INDIA","foreign_port":"BANGKOK","customer":"TO THE ORDER","customerCountry":"THAILAND","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"315","totalValueFC":"15461.2","currency":"USD","unitRateINR":26094.903999999999,"date":"23-Nov-2024","totalValueINR":"1304745.2","totalValueInUsd":"15461.2","indian_port":"Bombay Air","hs_no":"29419090","bill_no":"5851976","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"THAILAND","selfForZScoreResived":"Micronized","supplierPort":"Bombay Air","supplierAddress":"D-3,MATRU-ASHISH,NR.BAL-BHARATI SCH, MUMBAI","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1670524200,"product":"CEFDINIR RELATED COMPOUND B (QTY:2 X 10 MG, PRICE USD:903\/EACH)(FOC)","address":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,","city":"TURKAPALLY-V SHAMIRPET HYDERABAD,TE","supplier":"USP","supplierCountry":"INDIA","foreign_port":"NA","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.00002","unit":"KGS","unitRateFc":"90300000","totalValueFC":"2027.3","currency":"USD","unitRateINR":"8353214000","date":"09-Dec-2022","totalValueINR":"167064.28","totalValueInUsd":"2027.3","indian_port":"HYDERABAD AIR","hs_no":"29349910","bill_no":"3662395","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1674844200,"product":"CEFDINIR FORM-A USP MICRONIZED (RE-IMPORT VIDE SB NO:6813587DT:17.12.2021)","address":"8-3-677\/18, S K D NAGAR,YELLAREDDY GUDA","city":"HYDERABAD,TELANGANA","supplier":"HUMANIS SAGLIK A.S.","supplierCountry":"INDIA","foreign_port":"NA","customer":"VIRCHOW GROUP","customerCountry":"INDIA","quantity":"250.00","actualQuantity":"250","unit":"KGS","unitRateFc":"283","totalValueFC":"72002.3","currency":"USD","unitRateINR":"23547.5","date":"28-Jan-2023","totalValueINR":"5886870.65","totalValueInUsd":"72002.3","indian_port":"HYDERABAD AIR","hs_no":"29419090","bill_no":"4394957","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Micronized","supplierPort":"NA","supplierAddress":"","customerAddress":"8-3-677\/18, S K D NAGAR,YELLAREDDY GUDA"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1676226600,"product":"CEFDINIR USP MICRONIZED (RE-IMPORT VIDE SB NO:2719943 DT:19.05.2020)","address":"8-3-677\/18, S K D NAGAR,YELLAREDDY GUDA","city":"HYDERABAD,TELANGANA","supplier":"HIKMA PHARMACEUTICALS","supplierCountry":"INDIA","foreign_port":"NA","customer":"VIRCHOW GROUP","customerCountry":"INDIA","quantity":"84.98","actualQuantity":"84.975","unit":"KGS","unitRateFc":"448","totalValueFC":"38690.4","currency":"USD","unitRateINR":"37604.4","date":"13-Feb-2023","totalValueINR":"3195437.24","totalValueInUsd":"38690.4","indian_port":"HYDERABAD AIR","hs_no":"29419090","bill_no":"4614949","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Micronized","supplierPort":"NA","supplierAddress":"","customerAddress":"8-3-677\/18, S K D NAGAR,YELLAREDDY GUDA"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1704479400,"product":"CEFDINIR (RE-IMPORT VIDE SB NO:3899821 DT:13.09.2023)","address":"8-3-677\/18, S.K.D.NAGAR","city":"HYDERABAD.AP","supplier":"SANOVEL ILAC SANAYI ","supplierCountry":"INDIA","foreign_port":"ISTANBUL","customer":"VIRCHOW GROUP","customerCountry":"INDIA","quantity":"499.30","actualQuantity":"499.2975","unit":"KGS","unitRateFc":"280","totalValueFC":"142914.2","currency":"USD","unitRateINR":"23789.1","date":"06-Jan-2024","totalValueINR":"11877840.54","totalValueInUsd":"142914.2","indian_port":"Hyderabad Air","hs_no":"29419090","bill_no":"9549685","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"ISTANBUL","supplierAddress":"ISTINYE MAH.BALABANDERE CADNO:14 SARIYER ISTANBUL 00000-(0212)TURKEY TR","customerAddress":"8-3-677\/18, S.K.D.NAGAR"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1716143400,"product":"CEFDINIR (RE-IMPORT VIDE SB NO:8735524 DT:29.03.2024)","address":"8-3-677\/18, S.K.D.NAGAR","city":"HYDERABAD.AP","supplier":"GENVEON ILAC SAN VE TIC.AS.","supplierCountry":"INDIA","foreign_port":"ISTANBUL","customer":"VIRCHOW GROUP","customerCountry":"INDIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"280","totalValueFC":"57126.6","currency":"USD","unitRateINR":"23808.7","date":"20-May-2024","totalValueINR":"4761739.34","totalValueInUsd":"57126.6","indian_port":"Hyderabad Air","hs_no":"29419090","bill_no":"3571532","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"ISTANBUL","supplierAddress":"MASLAK MAH.SUMER SOK.NO.4,KAT:14 MASLAK OFFICE BUILDING, MOBMASLAK SARIYER,ISTANBUL TR","customerAddress":"8-3-677\/18, S.K.D.NAGAR"}]
    04-Jan-2021
    23-Nov-2024
    KGS
    overview
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    Average Price (USD/KGS)

    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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    FDA Orange Book

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    01

    ABBVIE

    U.S.A
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    Duphat
    Not Confirmed
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    • EDQM
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    RLD : Yes

    TE Code :

    CEFDINIR

    Brand Name : OMNICEF

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Approval Date : 1997-12-04

    Application Number : 50739

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

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    02

    ABBVIE

    U.S.A
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    RLD : Yes

    TE Code :

    CEFDINIR

    Brand Name : OMNICEF

    Dosage Form : FOR SUSPENSION;ORAL

    Dosage Strength : 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Approval Date : 1997-12-04

    Application Number : 50749

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

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    03

    ABBVIE

    U.S.A
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    RLD : Yes

    TE Code :

    CEFDINIR

    Brand Name : OMNICEF

    Dosage Form : FOR SUSPENSION;ORAL

    Dosage Strength : 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Approval Date : 2004-07-29

    Application Number : 50749

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

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    04

    ALKEM LABS LTD

    India
    Duphat
    Not Confirmed
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    ALKEM LABS LTD

    India
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    RLD : No

    TE Code : AB

    CEFDINIR

    Brand Name : CEFDINIR

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : 300MG

    Approval Date : 2021-02-19

    Application Number : 210220

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    05

    ALKEM LABS LTD

    India
    Duphat
    Not Confirmed
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    ALKEM LABS LTD

    India
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    RLD : No

    TE Code : AB

    CEFDINIR

    Brand Name : CEFDINIR

    Dosage Form : FOR SUSPENSION;ORAL

    Dosage Strength : 125MG/5ML

    Approval Date : 2021-02-19

    Application Number : 210534

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    06

    AUROBINDO PHARMA

    India
    Duphat
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    AUROBINDO PHARMA

    India
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    RLD : No

    TE Code : AB

    CEFDINIR

    Brand Name : CEFDINIR

    Dosage Form : FOR SUSPENSION;ORAL

    Dosage Strength : 125MG/5ML

    Approval Date : 2007-12-14

    Application Number : 65473

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    07

    AUROBINDO PHARMA

    India
    Duphat
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    AUROBINDO PHARMA

    India
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    Duphat
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    RLD : No

    TE Code : AB

    CEFDINIR

    Brand Name : CEFDINIR

    Dosage Form : FOR SUSPENSION;ORAL

    Dosage Strength : 250MG/5ML

    Approval Date : 2007-12-14

    Application Number : 65473

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    08

    CHARTWELL RX

    U.S.A
    Duphat
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    CHARTWELL RX

    U.S.A
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    RLD : No

    TE Code : AB

    CEFDINIR

    Brand Name : CEFDINIR

    Dosage Form : FOR SUSPENSION;ORAL

    Dosage Strength : 125MG/5ML

    Approval Date : 2007-04-06

    Application Number : 65337

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    09

    CHARTWELL RX

    U.S.A
    Duphat
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    CHARTWELL RX

    U.S.A
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    Duphat
    Not Confirmed
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    RLD : No

    TE Code : AB

    CEFDINIR

    Brand Name : CEFDINIR

    Dosage Form : FOR SUSPENSION;ORAL

    Dosage Strength : 250MG/5ML

    Approval Date : 2007-04-06

    Application Number : 65337

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    10

    LUPIN

    India
    Duphat
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    LUPIN

    India
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    RLD : No

    TE Code : AB

    CEFDINIR

    Brand Name : CEFDINIR

    Dosage Form : FOR SUSPENSION;ORAL

    Dosage Strength : 125MG/5ML

    Approval Date : 2006-05-31

    Application Number : 65259

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    ABOUT THIS PAGE

    Cefdinir Manufacturers

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

    Cefdinir Suppliers

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

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

    Cefdinir USDMF

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

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

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

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

    Cefdinir KDMF

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

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

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

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

    Cefdinir WC

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

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

    Cefdinir 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 Cefdinir as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Cefdinir 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 Cefdinir 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 Cefdinir and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cefdinir NDC to their finished compounded human drug products, they may choose to do so.

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

    Cefdinir GMP

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

    Cefdinir CoA

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

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

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