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    Chemistry

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    Also known as: Hydroxycobalamin, Hydroxocobalamin, Hydroxycob(lll)alamin, 13422-51-0, C08230
    Molecular Formula
    C62H90CoN13O15P
    Molecular Weight
    1347.4  g/mol
    InChI Key
    DQOCFCZRZOAIBN-UVKKECPRSA-L
    Hydroxocobalamin
    Injectable form of VITAMIN B 12 that has been used therapeutically to treat VITAMIN B 12 DEFICIENCY.
    1 2D Structure

    Hydroxocobalamin

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    cobalt(2+);[(2R,3S,4R,5S)-5-(5,6-dimethylbenzimidazol-1-yl)-4-hydroxy-2-(hydroxymethyl)oxolan-3-yl] [(2R)-1-[3-[(2R,3R,4Z,7S,9Z,12S,13S,14Z,17S,18S,19R)-2,13,18-tris(2-amino-2-oxoethyl)-7,12,17-tris(3-amino-3-oxopropyl)-3,5,8,8,13,15,18,19-octamethyl-2,7,12,17-tetrahydro-1H-corrin-21-id-3-yl]propanoylamino]propan-2-yl] phosphate;hydrate
    2.1.2 InChI
    InChI=1S/C62H90N13O14P.Co.H2O/c1-29-20-39-40(21-30(29)2)75(28-70-39)57-52(84)53(41(27-76)87-57)89-90(85,86)88-31(3)26-69-49(83)18-19-59(8)37(22-46(66)80)56-62(11)61(10,25-48(68)82)36(14-17-45(65)79)51(74-62)33(5)55-60(9,24-47(67)81)34(12-15-43(63)77)38(71-55)23-42-58(6,7)35(13-16-44(64)78)50(72-42)32(4)54(59)73-56;;/h20-21,23,28,31,34-37,41,52-53,56-57,76,84H,12-19,22,24-27H2,1-11H3,(H15,63,64,65,66,67,68,69,71,72,73,74,77,78,79,80,81,82,83,85,86);;1H2/q;+2;/p-2/t31-,34-,35-,36-,37+,41-,52-,53-,56?,57+,59-,60+,61+,62+;;/m1../s1
    2.1.3 InChI Key
    DQOCFCZRZOAIBN-UVKKECPRSA-L
    2.1.4 Canonical SMILES
    CC1=CC2=C(C=C1C)N(C=N2)C3C(C(C(O3)CO)OP(=O)([O-])OC(C)CNC(=O)CCC4(C(C5C6(C(C(C(=N6)C(=C7C(C(C(=N7)C=C8C(C(C(=N8)C(=C4[N-]5)C)CCC(=O)N)(C)C)CCC(=O)N)(C)CC(=O)N)C)CCC(=O)N)(C)CC(=O)N)C)CC(=O)N)C)O.O.[Co+2]
    2.1.5 Isomeric SMILES
    CC1=CC2=C(C=C1C)N(C=N2)[C@@H]3[C@@H]([C@@H]([C@H](O3)CO)OP(=O)([O-])O[C@H](C)CNC(=O)CC[C@@]\4([C@H](C5[C@]6([C@@]([C@@H](C(=N6)/C(=C\7/[C@@]([C@@H](C(=N7)/C=C\8/C([C@@H](C(=N8)/C(=C4\[N-]5)/C)CCC(=O)N)(C)C)CCC(=O)N)(C)CC(=O)N)/C)CCC(=O)N)(C)CC(=O)N)C)CC(=O)N)C)O.O.[Co+2]
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. Hydroxo-cobalamin

    2. Hydroxocobalamin

    3. Hydroxycobalamin

    2.2.2 Depositor-Supplied Synonyms

    1. Hydroxycobalamin

    2. Hydroxocobalamin

    3. Hydroxycob(lll)alamin

    4. 13422-51-0

    5. C08230

    2.3 Create Date
    2008-09-10
    3 Chemical and Physical Properties
    Molecular Weight 1347.4 g/mol
    Molecular Formula C62H90CoN13O15P
    Hydrogen Bond Donor Count10
    Hydrogen Bond Acceptor Count20
    Rotatable Bond Count26
    Exact Mass1346.574890 g/mol
    Monoisotopic Mass1346.574890 g/mol
    Topological Polar Surface Area453 Ų
    Heavy Atom Count92
    Formal Charge0
    Complexity3150
    Isotope Atom Count0
    Defined Atom Stereocenter Count13
    Undefined Atom Stereocenter Count1
    Defined Bond Stereocenter Count3
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count3
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameCyanokit
    PubMed HealthHydroxocobalamin (Injection)
    Drug ClassesCyanide Antidote
    Drug LabelHydroxocobalamin, the active ingredient in Cyanokit, is cobinamide dihydroxide dihydrogen phosphate (ester), mono (inner salt), 3'-ester with 5,6-dimethyl-1--D-ribofuranosyl-1H-benzimidazole. The drug substance is the hydroxylated active form of vi..
    Active IngredientHydroxocobalamin
    Dosage FormInjectable
    RouteInjection
    Strength5gm/vial (5gm/kit)
    Market StatusPrescription
    CompanyMerck Sante Sas

    2 of 4  
    Drug NameHydroxocobalamin
    PubMed HealthHydroxocobalamin (Injection)
    Drug ClassesCyanide Antidote
    Drug LabelHydroxocobalamin, the active ingredient in Cyanokit, is cobinamide dihydroxide dihydrogen phosphate (ester), mono (inner salt), 3'-ester with 5,6-dimethyl-1--D-ribofuranosyl-1H-benzimidazole. The drug substance is the hydroxylated active form of vi..
    Active IngredientHydroxocobalamin
    Dosage FormInjectable
    RouteInjection
    Strength1mg/ml
    Market StatusPrescription
    CompanyWatson Labs

    3 of 4  
    Drug NameCyanokit
    PubMed HealthHydroxocobalamin (Injection)
    Drug ClassesCyanide Antidote
    Drug LabelHydroxocobalamin, the active ingredient in Cyanokit, is cobinamide dihydroxide dihydrogen phosphate (ester), mono (inner salt), 3'-ester with 5,6-dimethyl-1--D-ribofuranosyl-1H-benzimidazole. The drug substance is the hydroxylated active form of vi..
    Active IngredientHydroxocobalamin
    Dosage FormInjectable
    RouteInjection
    Strength5gm/vial (5gm/kit)
    Market StatusPrescription
    CompanyMerck Sante Sas

    4 of 4  
    Drug NameHydroxocobalamin
    PubMed HealthHydroxocobalamin (Injection)
    Drug ClassesCyanide Antidote
    Drug LabelHydroxocobalamin, the active ingredient in Cyanokit, is cobinamide dihydroxide dihydrogen phosphate (ester), mono (inner salt), 3'-ester with 5,6-dimethyl-1--D-ribofuranosyl-1H-benzimidazole. The drug substance is the hydroxylated active form of vi..
    Active IngredientHydroxocobalamin
    Dosage FormInjectable
    RouteInjection
    Strength1mg/ml
    Market StatusPrescription
    CompanyWatson Labs

    4.2 Therapeutic Uses

    Hematinics

    National Library of Medicine's Medical Subject Headings online file (MeSH, 1999)

    Cyanokit is indicated for the treatment of known or suspected cyanide poisoning.

    Thomson Health Care Inc.; Physicians' Desk Reference 62 ed., Montvale, NJ 2008, p. 1032

    Pernicious anemia, both uncomplicated and accompanied by nervous system involvement.

    US Natl Inst Health; DailyMed. Current Medication Information for Hydroxocobalamin (February 2006). Available from, as of October 3, 2008: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=6636

    The US government considers cyanide to be among the most likely agents of chemical terrorism. Cyanide differs from many other biological or chemical agents for which little or no defense is available because its individual and public health effects are largely remediable through appropriate preparedness and response. Because the toxicity of the cyanide antidote currently available in the United States renders it ill-suited for use in terrorist incidents and other situations requiring rapid out-of-hospital treatment, hydroxocobalamin--an effective and safe cyanide antidote being used in other countries--has been introduced in the United States. Unlike the other available cyanide antidote, hydroxocobalamin can be administered at the scene of a cyanide disaster, and it need not be reserved for cases of confirmed cyanide poisoning but can be administered in cases of suspected poisoning. Both of these attributes facilitate the rapid intervention necessary for saving lives. To realize the potential benefits of hydroxocobalamin, progress also needs to be realized in other aspects of readiness, including but not limited to developing plans for ensuring local and regional availability of antidote, educating emergency responders and health care professionals in the recognition and management of cyanide poisoning, and raising public awareness of the potential for a chemical weapons attack and of how to respond.

    PMID:17976798 Eckstein M; J Emerg Med. 2008 Jul;35(1):59-65 (2008)

    For more Therapeutic Uses (Complete) data for HYDROXOCOBALAMIN (10 total), please visit the HSDB record page.

    4.3 Drug Warning

    Caution should be exercised when administering other cyanide antidotes simultaneously with Cyanokit, as the safety of coadministration has not been established. If a decision is made to administer another cyanide antidote with Cyanokit, these drugs should not be administered concurrently in the same IV line.

    Thomson Health Care Inc.; Physicians' Desk Reference 62 ed., Montvale, NJ 2008, p. 1033

    Use caution in the management of patients with known anaphylactic reactions to hydroxocobalamin or cyanocobalamin. Consideration should be given to use of alternative therapies, if available. Allergic reactions may include: anaphylaxis, chest tightness, edema, urticaria, pruritus, dyspnea, and rash. Allergic reactions including angioneurotic edema have also been reported in postmarketing experience.

    Thomson Health Care Inc.; Physicians' Desk Reference 62 ed., Montvale, NJ 2008, p. 1033

    Maternal Medication usually Compatible with Breast-Feeding: B12: Reported Sign or Symptom in Infant or Effect on Lactation: None. /from Table 6/

    Report of the American Academy of Pediatrics Committee on Drugs in Pediatrics 93 (1): 140 (1994)

    While determination of blood cyanide concentration is not required for management of cyanide poisoning and should not delay treatment with Cyanokit, collecting a pretreatment blood sample may be useful for documenting cyanide poisoning as sampling post- Cyanokit use may be inaccurate.

    Thomson Health Care Inc.; Physicians' Desk Reference 62 ed., Montvale, NJ 2008, p. 1033

    For more Drug Warnings (Complete) data for HYDROXOCOBALAMIN (19 total), please visit the HSDB record page.

    4.4 Drug Indication

    Treatment of known or suspected cyanide poisoning.

    Cyanokit is to be administered together with appropriate decontamination and supportive measures.

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Hematinics

    Agents which improve the quality of the blood, increasing the hemoglobin level and the number of erythrocytes. They are used in the treatment of anemias. (See all compounds classified as Hematinics.)

    Vitamin B Complex

    A group of water-soluble vitamins, some of which are COENZYMES. (See all compounds classified as Vitamin B Complex.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Antidote [EPC]
    5.3 ATC Code

    V03AB33

    B - Blood and blood forming organs

    B03 - Antianemic preparations

    B03B - Vitamin b12 and folic acid

    B03BA - Vitamin b12 (cyanocobalamin and analogues)

    B03BA03 - Hydroxocobalamin

    V - Various

    V03 - All other therapeutic products

    V03A - All other therapeutic products

    V03AB - Antidotes

    V03AB33 - Hydroxocobalamin

    5.4 Absorption, Distribution and Excretion

    The possibility of direct transport of hydroxocobalamin from the nasal cavity into the cerebrospinal fluid after nasal administration in rats was investigated and the results were compared with a human study. Hydroxocobalamin was given to rats (n=8) both intranasally (214 ug/rat) and intravenously (49.5 ug/rat) into the jugular vein using a Vascular Access Port (VAP). Prior to and after drug administration, blood and cerebrospinal fluid samples were taken and analysed by radioimmunoassay. The AUCcerebrospinal fluid/AUCplasma ratio after nasal delivery does not differ from the ratio after intravenous infusion, indicating that hydroxocobalamin enters the cerebrospinal fluid via the blood circulation across the blood-brain barrier (BBB). This same transport route is confirmed by the cumulative AUC-time profiles in cerebrospinal fluid and plasma, demonstrating a 30 min delay between plasma absorption and cerebrospinal fluid uptake of hydroxocobalamin in rats and in a comparative human study. The present results in rats show that there is no additional uptake of hydroxocobalamin in the cerebrospinal fluid after nasal delivery compared to intravenous administration, which is in accordance with the results found in humans.

    PMID:14668053 Van den Berg MP et al; J Drug Target 11 (6): 325-31 (2003)

    Fifty percent of the administered dose of hydroxocobalamin disappears from the injection site in 2.5 hours. Hydroxocobalamin is bound to plasma proteins and stored in the liver. It is excreted in the bile and undergoes some enterohepatic recycling. Within 72 hours after injection of 500 to 1000 mcg of hydroxocobalamin, 16 to 66 percent of the injected dose may appear in the urine. The major portion is excreted within the first 24 hours.

    US Natl Inst Health; DailyMed. Current Medication Information for Hydroxocobalamin (February 2006). Available from, as of October 3, 2008: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=6636

    Hydroxocobalamin is absorbed more slowly from the site of injection than is cyanocobalamin and there is some evidence that liver uptake of hydroxocobalamin may be greater than that of cyanocobalamin. It is believed that the increased retention of hydroxocobalamin compared with that of cyanocobalamin results from the greater affinity of hydroxocobalamin for both specific and nonspecific binding proteins in blood and tissues, as well as to its slower absorption from the injection site.

    American Society of Health System Pharmacists. AHFS Drug Information 2008. Bethesda, Maryland 2008

    In the presence of gastric acid and pancreatic proteases, dietary vitamin B12 is released from food and salivary binding protein and bound to gastric intrinsic factor. When the vitamin B12-intrinsic factor complex reaches the ileum, it interacts with a receptor on the mucosal cell surface and is actively transported into circulation. Adequate intrinsic factor, bile, and sodium bicarbonate (to provide a suitable pH) all are required for ileal transport of vitamin B12. Vitamin B12 deficiency in adults is rarely the result of a deficient diet per se; rather, it usually reflects a defect in one or another aspect of this complex sequence of absorption. Achlorhydria and decreased secretion of intrinsic factor by parietal cells secondary to gastric atrophy or gastric surgery is a common cause of vitamin B12 deficiency in adults. Antibodies to parietal cells or intrinsic factor complex also can play a prominent role in producing a deficiency. A number of intestinal diseases can interfere with absorption, including pancreatic disorders (loss of pancreatic protease secretion), bacterial overgrowth, intestinal parasites, sprue, and localized damage to ileal mucosal cells by disease or as a result of surgery. /Vitamin B-12/

    Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 11th ed. New York, NY: McGraw-Hill, 2006., p. 1454-5

    For more Absorption, Distribution and Excretion (Complete) data for HYDROXOCOBALAMIN (9 total), please visit the HSDB record page.

    5.5 Metabolism/Metabolites

    Toxicokinetics of hydroxocobalamin were studied in rats and in dogs after single administration. In dogs, the AUCs of free cobalamins-(III) and total cobalamins-(III) increased proportionally to the dose. Mean Cmax measured for free- and total cobalamins-(III) were 1 to 5 fold higher than those measured in humans treated with 5.0 and 10.0 g hydroxocobalamin. Terminal half-lives reached approximately 6 and 8 hours for free and total cobalamins-(III), respectively in dogs. Corresponding figures in rats amounted to 3 and 5 hours. In dogs, the clearance of total cobalamins-(III) (0.064 to 0.083 L/h/kg) was 6-7 fold lower than clearance of free cobalamins-(III).

    European Medicines Agency (EMEA), The European Agency for the Evaluation of Medicinal Products, European Public Assessment Report (EPAR) for Authorized Medicinal Products for Human Use; Cyanokit, Scientific Discussion (2007). Available from, as of November 24, 2008: https://www.emea.europa.eu/humandocs/Humans/EPAR/cyanokit/cyanokit.htm

    The binding of hydroxocobalamin to proteins may be regarded as reversible metabolism. Hydroxocobalamin also reacts with cyanide thereby forming cyanocobalamin. This complex is highly stable and is therefore regarded as a physiological end product of hydroxocobalamin especially during cyanide intoxication.

    European Medicines Agency (EMEA), The European Agency for the Evaluation of Medicinal Products, European Public Assessment Report (EPAR) for Authorized Medicinal Products for Human Use; Cyanokit, Scientific Discussion (2007). Available from, as of November 24, 2008: https://www.emea.europa.eu/humandocs/Humans/EPAR/cyanokit/cyanokit.htm

    5.6 Biological Half-Life

    In normal individuals, hydroxocobalamin has a plasma half life of 3-20 hours. In patients with cyanide poisoning, the half life is 14-24 hours.

    Olson, K.R. (Ed.); Poisoning & Drug Overdose. 5th ed. Lange Medical Books/McGraw-Hill. New York, N.Y. 2007., p. 459

    5.7 Mechanism of Action

    Hydroxocobalamin is a complexation agent that acts by direct binding of the cyanide ions, resulting in cyanocobalamin which is a highly stable, nontoxic compound that is excreted in the urine. In addition, increased blood pressure observed in some healthy subjects of the phase I clinical study and results of a non-clinical study performed in anesthetized rabbits suggest an interference of hydroxocobalamin with the NO system.

    European Medicines Agency (EMEA), The European Agency for the Evaluation of Medicinal Products, European Public Assessment Report (EPAR) for Authorized Medicinal Products for Human Use; Cyanokit, Scientific Discussion (2007). Available from, as of November 24, 2008: https://www.emea.europa.eu/humandocs/Humans/EPAR/cyanokit/cyanokit.htm

    VITAMIN B12 IS IMPLICATED IN PROTEIN SYNTH THROUGH ITS ROLE IN SYNTH OF AMINE ACID METHIONINE... /COBALAMINS/

    Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 1329

    COENZYME B12 IS REQUIRED FOR HYDROGEN TRANSFER & ISOMERIZATION WHEREBY METHYLMALONATE IS CONVERTED TO SUCCINATE, THUS INVOLVING COBALAMIN IN BOTH FAT & CARBOHYDRATE METABOLISM. ... METHYLCOBALAMIN IS REQUIRED FOR CONVERSION OF HOMOCYSTEINE TO METHIONINE IN MAMMALS. /COBALAMINS/

    Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 1329

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    09

    Interquim Mexico

    Mexico

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

    AACR Annual meeting
    Not Confirmed
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    Interquim Mexico

    Mexico

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

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    AACR Annual meeting
    Not Confirmed
    USDMF CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 40074-0011

    Start Marketing Date : 2022-02-08

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

     KDMF VMF Others AUDIT
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    10

    HealthTech BioActives

    Spain

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

    AACR Annual meeting
    Not Confirmed
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    Listed Suppliers

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    01

    EUROAPI

    France
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    CPhI Japan
    Exhibiting
    • fda
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    Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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    Hydroxocobalamin

    About the Company : EUROAPI focuses on reinventing active ingredient solutions to sustainably meet the needs of customers and patients worldwide. The company is a leading API player with a portfolio o...

    EUROAPI focuses on reinventing active ingredient solutions to sustainably meet the needs of customers and patients worldwide. The company is a leading API player with a portfolio of around 200 products, covering a wide range of technologies and innovative molecules through CDMO activities. Supported by 3,650 employees, strong R&D capabilities, and six manufacturing sites in Europe, EUROAPI delivers high-quality API manufacturing to customers in more than 80 countries. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    02

    Supriya Lifescience

    India
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    AACR Annual meeting
    Not Confirmed
    • fda
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    • WHO-GMP

    Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

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    Hydroxocobalamin

    About the Company : Supriya Lifescience Limited, established in 1987 and headquartered in Mumbai, is a globally recognized, technology-driven manufacturer of APIs, CDMO, and formulations. Its faciliti...

    Supriya Lifescience Limited, established in 1987 and headquartered in Mumbai, is a globally recognized, technology-driven manufacturer of APIs, CDMO, and formulations. Its facilities in Lote and Ambernath are approved by USFDA, EUGMP, Health Canada, and other agencies. Specializing in antihistamines, antiallergics, vitamins, anesthetics, and anti-asthmatics, Supriya serves 1500+ customers in over 86 countries, with 15+ USDMFs, 10+ CEPs, and a 1050 KL manufacturing capacity. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Supriya

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    03

    Vital Laboratories Private Limited

    India
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    CPhI Milan
    Booth #2H64
    • fda
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    • WHO-GMP

    Virtual BoothVital Laboratories – Trusted Global API Manufacturer of Quinine, Hyoscine, Antimalarials & Vitamins

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    Hydroxocobalamin

    About the Company : Vital Laboratories is an API and intermediates manufacturer established in 1998, beginning with quinine derivatives. Today, it is a global leader in quinine and hyoscine derivative...

    Vital Laboratories is an API and intermediates manufacturer established in 1998, beginning with quinine derivatives. Today, it is a global leader in quinine and hyoscine derivatives, antimalarials, and vitamins, offering over 60 synthetic and phytochemistry-based APIs. With backward integration from KSMs and two WHO GMP–approved manufacturing facilities in Vapi, India, accredited by leading global regulators, Vital delivers scale, efficiency, cost leadership, and reliable global supply security. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    CB

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    04

    Apicore

    India
    AACR Annual meeting
    Not Confirmed
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    Apicore

    India
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    AACR Annual meeting
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    Hydroxocobalamin

    About the Company : Apicore LLC, a wholly owned subsidiary of RK Pharma Inc is a leading process R&D and API manufacturing service provider for the worldwide pharmaceutical industry. We offer a wide p...

    Apicore LLC, a wholly owned subsidiary of RK Pharma Inc is a leading process R&D and API manufacturing service provider for the worldwide pharmaceutical industry. We offer a wide portfolio of services ranging from API’s for the generic industry to custom synthesis for early phase pharmaceutical research and branded products. Our USFDA approved facilities in India (Visakhapatnam, Andhra Pradesh and Vadodara, Gujarat) are both equipped with state-of-the-art analytical and research capabilities. While our worldwide network of locations seamlessly integrate with each other, each unit also independently houses a full
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    05

    Arihantanam Life Care

    India
    AACR Annual meeting
    Not Confirmed
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    Arihantanam Life Care

    India
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    AACR Annual meeting
    Not Confirmed
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    Hydroxocobalamin

    About the Company : Arihantanam Life Care Pvt. Ltd. is engaged in Manufacturing of Various Active Pharmaceuticals Ingredients Since 2006. We are a WHO-GMP approved facility and have installed moder...

    Arihantanam Life Care Pvt. Ltd. is engaged in Manufacturing of Various Active Pharmaceuticals Ingredients Since 2006. We are a WHO-GMP approved facility and have installed modern facilities to produce various Sterile lyophilized, Freeze drying and Non Sterile Active Pharmaceuticals Ingredients (API) Products, We have adequate infrastructure and a dynamic team to produce the best Quality and to ensure timely supply. We have dedicated testing team for (Quality Control), (Quality Assurance),(Manufacturing) and Commercial (Purchase & Sale) related activities.
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    06

    CSPC Pharmaceutical Group

    China
    AACR Annual meeting
    Not Confirmed
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    CSPC Pharmaceutical Group

    China
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    AACR Annual meeting
    Not Confirmed
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    Hydroxocobalamin

    About the Company : CSPC Pharmaceutical Group Limited ("CSPC") (Stock code: 1093. HK) is a leading pharmaceutical group in China. It was established in 1997. Since the very beginning, CSPC has taken ...

    CSPC Pharmaceutical Group Limited ("CSPC") (Stock code: 1093. HK) is a leading pharmaceutical group in China. It was established in 1997. Since the very beginning, CSPC has taken “All for better medicine, all for a healthier world” as its corporate mission. In all aspects of development, procurement, production, and distribution, they are committed to ensuring the health of people by creating high-quality, effective, reliable, and innovative drugs that meet the needs of society.
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    07

    Guangzhou Tosun Pharmaceutical

    China
    AACR Annual meeting
    Not Confirmed
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    Guangzhou Tosun Pharmaceutical

    China
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    AACR Annual meeting
    Not Confirmed
    • fda
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    Hydroxocobalamin

    About the Company : Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Ex...

    Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Excipients, Herbal extracts, Formulation of Chinese & Western Medicine. With abundant economic strength, the group has successfully developed to a pharmaceutical group enterprise wich intergrets operation of medicine & related products, processing & manufacturing, and importation & exportation together.
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    08

    HealthTech BioActives

    Spain
    AACR Annual meeting
    Not Confirmed
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    HealthTech BioActives

    Spain
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    AACR Annual meeting
    Not Confirmed
    • fda
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    Hydroxocobalamin

    About the Company : HTBA (HealthTech BioActives), a global company specialized in flavonoids and vitamin B12 derivatives, with over 40 years of experience in natural-origin pharmaceutical ingredients....

    HTBA (HealthTech BioActives), a global company specialized in flavonoids and vitamin B12 derivatives, with over 40 years of experience in natural-origin pharmaceutical ingredients. We cover the entire value chain, from raw materials to merchandise, with global reach in pharmaceuticals, dietary supplements, human and animal nutrition, and in cosmetics. We recognize that our ingredients directly impact our customers’ activities and the well-being of end consumers. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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    09

    Interquim Mexico

    Mexico
    AACR Annual meeting
    Not Confirmed
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    Interquim Mexico

    Mexico
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    AACR Annual meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Hydroxocobalamin

    About the Company : Welcome to Interquim! We are a Mexican company dedicated to the production of active pharmaceutical ingredients for both domestic and international markets. The company was founded...

    Welcome to Interquim! We are a Mexican company dedicated to the production of active pharmaceutical ingredients for both domestic and international markets. The company was founded in 1970 with the firm intention of contributing to the development of the pharmaceutical industry. As a leader in the development and production of active ingredients manufacturer, we have an ongoing commitment to research and product innovation as well as service excellence.
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    10

    Micro Orgo Chem

    India
    AACR Annual meeting
    Not Confirmed
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    Micro Orgo Chem

    India
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    AACR Annual meeting
    Not Confirmed
    • fda
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    • WHO-GMP
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    Hydroxocobalamin

    About the Company : Micro Orgo Chem is a pharmaceutical establishment, manufacturing niche Active Pharmaceutical Ingredients (API). Founded in 1992, we have a mission of providing high quality drugs t...

    Micro Orgo Chem is a pharmaceutical establishment, manufacturing niche Active Pharmaceutical Ingredients (API). Founded in 1992, we have a mission of providing high quality drugs to the market. Over these years, we have expanded our product portfolio to hormones, narcotics analgesics, steroids and more. We aspire to use our experience of over two decades to continue to provide Micro Orgo Chem’s finest drugs to those in need.
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    FDA Orange Book

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    01

    ABRAXIS PHARM

    U.S.A
    AACR Annual meeting
    Not Confirmed
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    ABRAXIS PHARM

    U.S.A
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    AACR Annual meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    RLD : No

    TE Code :

    HYDROXOCOBALAMIN

    Brand Name : HYDROXOCOBALAMIN

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 1MG/ML

    Approval Date : 1982-01-01

    Application Number : 84921

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    02

    WATSON LABS

    Ireland
    AACR Annual meeting
    Not Confirmed
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    WATSON LABS

    Ireland
    arrow
    AACR Annual meeting
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    RLD : No

    TE Code :

    HYDROXOCOBALAMIN

    Brand Name : HYDROXOCOBALAMIN

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 1MG/ML

    Approval Date : 1982-01-01

    Application Number : 85528

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    03

    ACTAVIS

    Ireland
    AACR Annual meeting
    Not Confirmed
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    ACTAVIS

    Ireland
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    AACR Annual meeting
    Not Confirmed
    • fda
    • EDQM
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    RLD : No

    TE Code :

    HYDROXOCOBALAMIN

    Brand Name : HYDROXOCOBALAMIN

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 1MG/ML

    Approval Date : 1982-01-01

    Application Number : 85998

    RX/OTC/DISCN : RX

    RLD : No

    TE Code :

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    04

    BEL MAR

    U.S.A
    AACR Annual meeting
    Not Confirmed
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    BEL MAR

    U.S.A
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    AACR Annual meeting
    Not Confirmed
    • fda
    • EDQM
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    RLD : No

    TE Code :

    HYDROXOCOBALAMIN

    Brand Name : HYDROXOMIN

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 1MG/ML

    Approval Date : 1982-01-01

    Application Number : 84629

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    05

    BTG INTL

    U.S.A
    AACR Annual meeting
    Not Confirmed
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    BTG INTL

    U.S.A
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    AACR Annual meeting
    Not Confirmed
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    RLD : Yes

    TE Code :

    HYDROXOCOBALAMIN

    Brand Name : CYANOKIT

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 5GM/VIAL (5GM/KIT)

    Approval Date : 2011-04-08

    Application Number : 22041

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    06

    BTG INTL

    U.S.A
    AACR Annual meeting
    Not Confirmed
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    BTG INTL

    U.S.A
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    AACR Annual meeting
    Not Confirmed
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    RLD : No

    TE Code :

    HYDROXOCOBALAMIN

    Brand Name : CYANOKIT

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 2.5GM/VIAL (5GM/KIT)

    Approval Date : 2006-12-15

    Application Number : 22041

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    07

    MERCK

    U.S.A
    AACR Annual meeting
    Not Confirmed
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    MERCK

    U.S.A
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    AACR Annual meeting
    Not Confirmed
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    RLD : No

    TE Code :

    HYDROXOCOBALAMIN

    Brand Name : ALPHAREDISOL

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 1MG/ML

    Approval Date : 1982-01-01

    Application Number : 80778

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    Europe

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    01

    Orion Corporation

    Finland
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    AACR Annual meeting
    Not Confirmed
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    Regulatory Info : Approved

    Registration Country : Sweden

    Hydroxokobalaminacetat

    Brand Name : Hydroxocobalamin Orion

    Dosage Form : Injectable Solution

    Dosage Strength : 1mg/ml

    Packaging :

    Approval Date : 11-09-2024

    Application Number : 2.02E+13

    Regulatory Info : Approved

    Registration Country : Sweden

    Fermion Orion Company Banner

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    02

    SERB SA

    Belgium
    AACR Annual meeting
    Not Confirmed
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    SERB SA

    Belgium
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    AACR Annual meeting
    Not Confirmed
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    Regulatory Info : Not Marketed

    Registration Country : Norway

    Hydroxocobalamin

    Brand Name : Cyanokit

    Dosage Form : Powder For Infusion Solution

    Dosage Strength : 2.5g

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Not Marketed

    Registration Country : Norway

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    03

    SERB SA

    Belgium
    AACR Annual meeting
    Not Confirmed
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    SERB SA

    Belgium
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    AACR Annual meeting
    Not Confirmed
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    Regulatory Info : Marketed

    Registration Country : Norway

    Hydroxocobalamin

    Brand Name : Cyanokit

    Dosage Form : Powder For Infusion Solution

    Dosage Strength : 5g

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Marketed

    Registration Country : Norway

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    04

    Serb

    Belgium
    AACR Annual meeting
    Not Confirmed
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    Serb

    Belgium
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    AACR Annual meeting
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    Regulatory Info : Prescription

    Registration Country : Estonia

    Hydroxocobalamin

    Brand Name : Cyanokit

    Dosage Form : Solution For Injection

    Dosage Strength : 5g

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Prescription

    Registration Country : Estonia

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    05

    Serb Sa

    Belgium
    AACR Annual meeting
    Not Confirmed
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    Serb Sa

    Belgium
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    AACR Annual meeting
    Not Confirmed
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    Regulatory Info : Authorized

    Registration Country : Spain

    Hydroxocobalamin

    Brand Name : Cyanokit

    Dosage Form : Powder For Infusion Solution

    Dosage Strength : 5G

    Packaging :

    Approval Date : 19-11-2010

    Application Number : 7420002

    Regulatory Info : Authorized

    Registration Country : Spain

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    06

    Serb Sa

    Belgium
    AACR Annual meeting
    Not Confirmed
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    Serb Sa

    Belgium
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    AACR Annual meeting
    Not Confirmed
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    Regulatory Info : Approved

    Registration Country : Sweden

    Hydroxocobalamin

    Brand Name : Cyanokit

    Dosage Form : Solution For Injection

    Dosage Strength : 5g

    Packaging :

    Approval Date : 07-10-2010

    Application Number : 2.01E+13

    Regulatory Info : Approved

    Registration Country : Sweden

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    07

    TEOFARMA Srl

    Country
    AACR Annual meeting
    Not Confirmed
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    TEOFARMA Srl

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    Calcium Folinate; Hydroxocobalamin

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    Regulatory Info : Withdrawn

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    Hydroxocobalamin

    Brand Name : Cobalin-H

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    Regulatory Info : PRESCRIPTION

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    HYDROXOCOBALAMIN

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    ABOUT THIS PAGE

    Looking for 13422-51-0 / Hydroxocobalamin API manufacturers, exporters & distributors?

    Hydroxocobalamin manufacturers, exporters & distributors 1

    40

    PharmaCompass offers a list of Hydroxocobalamin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Hydroxocobalamin manufacturer or Hydroxocobalamin supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Hydroxocobalamin manufacturer or Hydroxocobalamin supplier.

    API | Excipient name

    Hydroxocobalamin

    Synonyms

    Hydroxycobalamin, Hydroxycob(lll)alamin, 13422-51-0, C08230

    Cas Number

    13422-51-0

    About Hydroxocobalamin

    Injectable form of VITAMIN B 12 that has been used therapeutically to treat VITAMIN B 12 DEFICIENCY.

    Hidroxocobalamina Manufacturers

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

    Hidroxocobalamina Suppliers

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

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

    Hidroxocobalamina USDMF

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

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

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

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

    Hidroxocobalamina KDMF

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

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

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

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

    Hidroxocobalamina 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 Hidroxocobalamina as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Hidroxocobalamina GMP

    Hidroxocobalamina 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 Hidroxocobalamina GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Hidroxocobalamina GMP manufacturer or Hidroxocobalamina GMP API supplier for your needs.

    Hidroxocobalamina CoA

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

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

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