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    Chemistry

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    Also known as: Calcitonin-salmon, Thyrocalcitonin (salmon), Cibacalcin, Calcitonina, Calcitar, Bionocalcin
    Molecular Formula
    C145H240N44O48S2
    Molecular Weight
    3431.9  g/mol
    InChI Key
    BBBFJLBPOGFECG-VJVYQDLKSA-N
    Calcitonin
    Synthetic peptide, 32 residues long formulated as a nasal spray.
    1 2D Structure

    Calcitonin

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (4S)-4-[[(2S)-5-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-6-amino-2-[[2-[[(2S)-2-[[(2S)-2-[[(4R,7S,10S,13S,16S,19S,22R)-22-amino-16-(2-amino-2-oxoethyl)-7-[(1R)-1-hydroxyethyl]-10,19-bis(hydroxymethyl)-13-(2-methylpropyl)-6,9,12,15,18,21-hexaoxo-1,2-dithia-5,8,11,14,17,20-hexazacyclotricosane-4-carbonyl]amino]-3-methylbutanoyl]amino]-4-methylpentanoyl]amino]acetyl]amino]hexanoyl]amino]-4-methylpentanoyl]amino]-3-hydroxypropanoyl]amino]-5-oxopentanoyl]amino]-5-[[(2S)-1-[[(2S)-1-[[(2S)-6-amino-1-[[(2S)-1-[[(2S)-5-amino-1-[[(2S,3R)-1-[[(2S)-1-[(2S)-2-[[(2S)-1-[[(2S,3R)-1-[[(2S)-4-amino-1-[[(2S,3R)-1-[[2-[[(2S)-1-[[2-[[(2S,3R)-1-[(2S)-2-carbamoylpyrrolidin-1-yl]-3-hydroxy-1-oxobutan-2-yl]amino]-2-oxoethyl]amino]-3-hydroxy-1-oxopropan-2-yl]amino]-2-oxoethyl]amino]-3-hydroxy-1-oxobutan-2-yl]amino]-1,4-dioxobutan-2-yl]amino]-3-hydroxy-1-oxobutan-2-yl]amino]-5-carbamimidamido-1-oxopentan-2-yl]carbamoyl]pyrrolidin-1-yl]-3-(4-hydroxyphenyl)-1-oxopropan-2-yl]amino]-3-hydroxy-1-oxobutan-2-yl]amino]-1,5-dioxopentan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-1-oxohexan-2-yl]amino]-3-(1H-imidazol-5-yl)-1-oxopropan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-5-oxopentanoic acid
    2.1.2 InChI
    InChI=1S/C145H240N44O48S2/c1-65(2)45-86(175-139(232)110(70(11)12)183-136(229)99-63-239-238-62-79(148)117(210)178-96(59-191)134(227)174-92(52-104(151)202)131(224)172-90(49-69(9)10)129(222)180-98(61-193)135(228)187-114(74(16)197)142(235)181-99)118(211)158-55-106(204)162-80(25-18-20-40-146)120(213)169-89(48-68(7)8)128(221)179-97(60-192)133(226)167-83(34-37-102(149)200)122(215)165-85(36-39-109(207)208)123(216)171-88(47-67(5)6)127(220)173-91(51-77-54-156-64-161-77)130(223)164-81(26-19-21-41-147)121(214)170-87(46-66(3)4)126(219)166-84(35-38-103(150)201)125(218)186-113(73(15)196)141(234)177-94(50-76-30-32-78(199)33-31-76)143(236)189-44-24-29-101(189)137(230)168-82(27-22-42-157-145(154)155)124(217)185-112(72(14)195)140(233)176-93(53-105(152)203)132(225)184-111(71(13)194)138(231)160-56-107(205)163-95(58-190)119(212)159-57-108(206)182-115(75(17)198)144(237)188-43-23-28-100(188)116(153)209/h30-33,54,64-75,79-101,110-115,190-199H,18-29,34-53,55-63,146-148H2,1-17H3,(H2,149,200)(H2,150,201)(H2,151,202)(H2,152,203)(H2,153,209)(H,156,161)(H,158,211)(H,159,212)(H,160,231)(H,162,204)(H,163,205)(H,164,223)(H,165,215)(H,166,219)(H,167,226)(H,168,230)(H,169,213)(H,170,214)(H,171,216)(H,172,224)(H,173,220)(H,174,227)(H,175,232)(H,176,233)(H,177,234)(H,178,210)(H,179,221)(H,180,222)(H,181,235)(H,182,206)(H,183,229)(H,184,225)(H,185,217)(H,186,218)(H,187,228)(H,207,208)(H4,154,155,157)/t71-,72-,73-,74-,75-,79+,80+,81+,82+,83+,84+,85+,86+,87+,88+,89+,90+,91+,92+,93+,94+,95+,96+,97+,98+,99+,100+,101+,110+,111+,112+,113+,114+,115+/m1/s1
    2.1.3 InChI Key
    BBBFJLBPOGFECG-VJVYQDLKSA-N
    2.1.4 Canonical SMILES
    CC(C)CC1C(=O)NC(C(=O)NC(C(=O)NC(CSSCC(C(=O)NC(C(=O)NC(C(=O)N1)CC(=O)N)CO)N)C(=O)NC(C(C)C)C(=O)NC(CC(C)C)C(=O)NCC(=O)NC(CCCCN)C(=O)NC(CC(C)C)C(=O)NC(CO)C(=O)NC(CCC(=O)N)C(=O)NC(CCC(=O)O)C(=O)NC(CC(C)C)C(=O)NC(CC2=CN=CN2)C(=O)NC(CCCCN)C(=O)NC(CC(C)C)C(=O)NC(CCC(=O)N)C(=O)NC(C(C)O)C(=O)NC(CC3=CC=C(C=C3)O)C(=O)N4CCCC4C(=O)NC(CCCNC(=N)N)C(=O)NC(C(C)O)C(=O)NC(CC(=O)N)C(=O)NC(C(C)O)C(=O)NCC(=O)NC(CO)C(=O)NCC(=O)NC(C(C)O)C(=O)N5CCCC5C(=O)N)C(C)O)CO
    2.1.5 Isomeric SMILES
    C[C@H]([C@H]1C(=O)N[C@@H](CSSC[C@@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N1)CO)CC(C)C)CC(=O)N)CO)N)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CC(C)C)C(=O)NCC(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CO)C(=O)N[C@@H](CCC(=O)N)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC2=CN=CN2)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(=O)N)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CC3=CC=C(C=C3)O)C(=O)N4CCC[C@H]4C(=O)N[C@@H](CCCNC(=N)N)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CC(=O)N)C(=O)N[C@@H]([C@@H](C)O)C(=O)NCC(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H]([C@@H](C)O)C(=O)N5CCC[C@H]5C(=O)N)O
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. Calcihexal

    2. Calcimar

    3. Calcitonin Salmon

    4. Forcaltonin

    5. Fortical

    6. Miacalcic

    7. Miacalcin

    8. Recombinant Salmon Calcitonin

    9. Salcatonin

    10. Salmon Calcitonin (1-32)

    11. Synthetic Salmon Calcitonin

    2.2.2 Depositor-Supplied Synonyms

    1. Calcitonin-salmon

    2. Thyrocalcitonin (salmon)

    3. Cibacalcin

    4. Calcitonina

    5. Calcitar

    6. Bionocalcin

    7. Calcimonta

    8. Calcitoran

    9. Cibacalcine

    10. Eptacalcin

    11. Miracalcic

    12. Osseocalcina

    13. Ostostabil

    14. Porostenina

    15. Prontocalcin

    16. Rulicalcin

    17. Salmocalcin

    18. Salmotonin

    19. Tonocalcin

    20. Astronin

    21. Biocalcin

    22. Calciben

    23. Calcinil

    24. Calcioton

    25. Calogen

    26. Calsynar

    27. Caltine

    28. Catonin

    29. Citonina

    30. Ipocalcin

    31. Kalsimin

    32. Oseototal

    33. Osteobion

    34. Osteovis

    35. Ostosalm

    36. Quosten

    37. Riostin

    38. Salcatyn

    39. Salmofar

    40. Stalcin

    41. Staporos

    42. Steocin

    43. Cadens

    44. Casalm

    45. Ostora

    46. Salcat

    47. Ucecal

    48. Calco

    49. Karil

    50. Sical

    51. Isi-calcin

    52. Calcitonin,salmon

    53. Calsynar Lyo L

    54. Calcitonin(salmon)

    55. Calcitonin, Salmar

    56. Salmon Calcitonin I

    57. Calcitonin Vom Lachs

    58. Calcitonine De Saumon

    59. Tz-ct

    60. Unii-7sfc6u2vi5

    61. Salmon Calcitonin-(i-32)

    62. 7sfc6u2vi5

    63. Salmon Calcitonin-(1-32)

    64. Chebi:3306

    65. Calcitonin, Salmon, For Bioassay

    66. Dtxsid601026667

    67. Calcitonin [usan:inn:ban:jan]

    68. Einecs 256-342-8

    69. Ncgc00167232-01

    70. Calcitonin Salmon, >=97% (hplc), Powder

    71. Calcitonin Salmon, European Pharmacopoeia (ep) Reference Standard

    72. Calcitonin Salmon, United States Pharmacopeia (usp) Reference Standard

    73. Cyclo-[cys-ser-asn-leu-ser-thr-cys]-val-leu-gly-lys-leu-ser-gln-glu-leu-his-lys-leu-gln-thr-tyr-pro-arg-thr-asn-thr-gly-ser-gly-thr-pro-nh2

    2.3 Create Date
    2007-07-16
    3 Chemical and Physical Properties
    Molecular Weight 3431.9 g/mol
    Molecular Formula C145H240N44O48S2
    XLogP3-16.6
    Hydrogen Bond Donor Count52
    Hydrogen Bond Acceptor Count55
    Rotatable Bond Count99
    Exact Mass3430.7166627 g/mol
    Monoisotopic Mass3429.7133079 g/mol
    Topological Polar Surface Area1560 Ų
    Heavy Atom Count239
    Formal Charge0
    Complexity7970
    Isotope Atom Count0
    Defined Atom Stereocenter Count34
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Indication

    Used in the treatment of symptomatic Paget's disease for patients unresponsive to alternate treatments or intolerant to such treatments. In addition, it is used in emergency situations when serum calcium levels must be decreased quickly until the underlying condition is identified. It can also be added to existing therapeutic regimens for hypercalcemia such as intravenous fluids and furosemide, oral phosphate or corticosteroids, or other agents. Calcitonin can be used in patients with azotemia and cases where intravenous fluids would be contraindicated due to limited cardiac reserves. Also for the treatment of post-menopausal osteoporosis in women more than 5 years post-menopause.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Calcitonin inhibits bone resorption by osteoclasts (bone remodeling cells) and promotes bone formation by osteoblasts. This leads to a net increase in bone mass and a reduction in plasma calcium levels. It also promotes the renal excretion of ions such as calcium, phosphate, sodium, magnesium, and potassium by decreasing tubular reabsorption. In consequence, there is an increase in the jejunal secretion of water, sodium, potassium, and chloride.

    5.2 MeSH Pharmacological Classification

    Bone Density Conservation Agents

    Agents that inhibit BONE RESORPTION and/or favor BONE MINERALIZATION and BONE REGENERATION. They are used to heal BONE FRACTURES and to treat METABOLIC BONE DISEASES such as OSTEOPOROSIS. (See all compounds classified as Bone Density Conservation Agents.)

    Calcium-Regulating Hormones and Agents

    Hormones and molecules with calcium-regulating hormone-like actions that modulate OSTEOLYSIS and other extra-skeletal activities to maintain calcium homeostasis. (See all compounds classified as Calcium-Regulating Hormones and Agents.)

    5.3 Absorption, Distribution and Excretion

    Absorption

    Salmon calcitonin is rapidly absorbed with bioavailability of 71% following subcutaneous injection and 66% following intramuscular injection in humans. Via the nasal route, the bioavailability varies between 3 to 5% relative to IM.

    Route of Elimination

    Urine. Studies with injectable calcitonin show increases in the excretion of filtered phosphate, calcium, and sodium by decreasing their tubular reabsorption in the kidney.

    Volume of Distribution

    0.15 to 0.3 L/kg

    5.4 Metabolism/Metabolites

    Salmon calcitonin primarily undergoes degradation in the kidneys to form pharmacologically inactive metabolites. It is also metabolized in the blood and the peripheral tissue.

    5.5 Biological Half-Life

    Half-life elimination (terminal): I.M. 58 minutes; SubQ 59 to 64 minutes; Nasal: ~18 to 23 minutes

    5.6 Mechanism of Action

    Calcitonin binds to the calcitonin receptor (found primarily in osteoclasts) which then enhances the production of vitamin D producing enzymes (25-hydroxyvitamine D-24-hydroxylase), leading to greater calcium retention and enhanced bone density. Binding of calcitonin to its receptor also activates adenylyl cyclase and the phosphatidyl-inositol-calcium pathway.

    API Reference Price

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Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1657477800,"product":"DES5-SER CALCITONIN SALMON (100 MG)","address":"901-911 9TH FLR ISCON ELEGANCE NR SHAPATH 5 S G HIGHWAY Contact No: 9","city":"AHMEDABAD","supplier":"BIOMATIK CORPORATION","supplierCountry":"CHINA","foreign_port":"NA","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.0001","unit":"KGS","unitRateFc":"10687500","totalValueFC":"1211.5","currency":"USD","unitRateINR":"963367700","date":"11-Jul-2022","totalValueINR":"96336.77","totalValueInUsd":"1211.5","indian_port":"AHMEDABAD AIR","hs_no":"29339990","bill_no":"9498163","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"901-911 9TH FLR ISCON ELEGANCE NR SHAPATH 5 S G HIGHWAY Contact No: 9"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1657477800,"product":"FORMYL CYS1 CALCITONIN SALMON (100 MG)","address":"901-911 9TH FLR ISCON ELEGANCE NR SHAPATH 5 S G HIGHWAY Contact No: 9","city":"AHMEDABAD","supplier":"BIOMATIK CORPORATION","supplierCountry":"CHINA","foreign_port":"NA","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.0001","unit":"KGS","unitRateFc":"12094200","totalValueFC":"1371","currency":"USD","unitRateINR":"1090167100","date":"11-Jul-2022","totalValueINR":"109016.71","totalValueInUsd":"1371","indian_port":"AHMEDABAD AIR","hs_no":"29339990","bill_no":"9498163","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"901-911 9TH FLR ISCON ELEGANCE NR SHAPATH 5 S G HIGHWAY Contact No: 9"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1657477800,"product":"FORMYL CYS11 CALCITONIN SALMON (100 MG)","address":"901-911 9TH FLR ISCON ELEGANCE NR SHAPATH 5 S G HIGHWAY Contact No: 9","city":"AHMEDABAD","supplier":"BIOMATIK CORPORATION","supplierCountry":"CHINA","foreign_port":"NA","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.0001","unit":"KGS","unitRateFc":"14310000","totalValueFC":"1622.2","currency":"USD","unitRateINR":"1289898600","date":"11-Jul-2022","totalValueINR":"128989.86","totalValueInUsd":"1622.2","indian_port":"AHMEDABAD AIR","hs_no":"29339990","bill_no":"9498163","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"901-911 9TH FLR ISCON ELEGANCE NR SHAPATH 5 S G HIGHWAY Contact No: 9"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1668796200,"product":"SALMON CALCITONIN USP","address":"PLOT NO.293 BOMMASANDRA JIGANI,LIN K ROAD JIGANI INDUSTRIAL AREA","city":"BANGALORE,KARNATAKA","supplier":"BCN PEPTIDES","supplierCountry":"SPAIN","foreign_port":"NA","customer":"STELIS BIOPHARMA","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"5","unit":"GMS","unitRateFc":"15000","totalValueFC":"75907.3","currency":"USD","unitRateINR":"1239000","date":"19-Nov-2022","totalValueINR":"6195000","totalValueInUsd":"75907.3","indian_port":"BANGALORE AIR","hs_no":"29371900","bill_no":"3376865","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PLOT NO.293 BOMMASANDRA JIGANI,LIN K ROAD JIGANI INDUSTRIAL AREA"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1674066600,"product":"APICS SALMON 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D6 D8, SY.NO. 234\/2,234\/3,","city":"TURKAPALLY(V),SHAMEERPET, HYDERABAD","supplier":"UNITED STATES PHARMACOPEIAL ","supplierCountry":"SWEDEN","foreign_port":"WASHINGTON, DULLES I","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.00064","unit":"KGS","unitRateFc":"63425000","totalValueFC":"41720.6","currency":"USD","unitRateINR":"5412976969","date":"28-Mar-2024","totalValueINR":"3464305.26","totalValueInUsd":"41720.6","indian_port":"Hyderabad Air","hs_no":"29371900","bill_no":"2774565","productDescription":"API","marketType":"REGULATED MARKET","country":"SWEDEN","selfForZScoreResived":"Pharma Grade","supplierPort":"WASHINGTON, DULLES I","supplierAddress":"7135 ENGLISH MUFFIN WAY FREDERICK,MD, US 21704, UNITED STATES OF AMERICA United States","customerAddress":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725906600,"product":"CALCITONIN SALMON USP","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"BCN PEPTIDES","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"CIPLA","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"10","unit":"GMS","unitRateFc":"15000","totalValueFC":"172548","currency":"EUR","unitRateINR":"1445973.6","date":"10-Sep-2024","totalValueINR":"14459735.91","totalValueInUsd":"172548","indian_port":"Bombay Air","hs_no":"29371900","bill_no":"5520926","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"PI ELS VINYETS I ELS FOGAR SANT QUINTI DE ME B 08777 ES SPAIN SPAIN","customerAddress":"MUMBAI CENTRAL,"}]
    18-Jan-2021
    11-Nov-2024
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - INJECTABLE;INJECTION - 100 IU/ML **F...DOSAGE - INJECTABLE;INJECTION - 100 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 17808

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    DOSAGE - INJECTABLE;INJECTION - 200 IU/ML

    USFDA APPLICATION NUMBER - 17808

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    DOSAGE - SPRAY, METERED;NASAL - 200 IU/SPRAY ...DOSAGE - SPRAY, METERED;NASAL - 200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20313

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    ABOUT THIS PAGE

    Calcitonin Salmon Recombinant Manufacturers

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

    Calcitonin Salmon Recombinant Suppliers

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

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

    Calcitonin Salmon Recombinant USDMF

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

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

    click here to find a list of Calcitonin Salmon Recombinant suppliers with USDMF on PharmaCompass.

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

    Calcitonin Salmon Recombinant CEP

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

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

    Calcitonin Salmon Recombinant WC

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

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

    Calcitonin Salmon Recombinant 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 Calcitonin Salmon Recombinant as an active pharmaceutical ingredient (API).

    Finished drug products

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

    click here to find a list of Calcitonin Salmon Recombinant suppliers with NDC on PharmaCompass.

    Calcitonin Salmon Recombinant GMP

    Calcitonin Salmon Recombinant 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 Calcitonin Salmon Recombinant 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 Calcitonin Salmon Recombinant GMP manufacturer or Calcitonin Salmon Recombinant GMP API supplier for your needs.

    Calcitonin Salmon Recombinant CoA

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

    Calcitonin Salmon Recombinant CoA mostly includes findings from lab analyses of a specific batch. For each Calcitonin Salmon Recombinant 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.

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