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    Chemistry

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    Also known as: Niacinamide, 98-92-0, 3-pyridinecarboxamide, Pyridine-3-carboxamide, Nicotinic acid amide, Vitamin pp
    Molecular Formula
    C6H6N2O
    Molecular Weight
    122.12  g/mol
    InChI Key
    DFPAKSUCGFBDDF-UHFFFAOYSA-N
    FDA UNII
    25X51I8RD4
    Niacinamide
    An important compound functioning as a component of the coenzyme NAD. Its primary significance is in the prevention and/or cure of blacktongue and PELLAGRA. Most animals cannot manufacture this compound in amounts sufficient to prevent nutritional deficiency and it therefore must be supplemented through dietary intake.
    1 2D Structure

    Niacinamide

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    pyridine-3-carboxamide
    2.1.2 InChI
    InChI=1S/C6H6N2O/c7-6(9)5-2-1-3-8-4-5/h1-4H,(H2,7,9)
    2.1.3 InChI Key
    DFPAKSUCGFBDDF-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    C1=CC(=CN=C1)C(=O)N
    2.2 Other Identifiers
    2.2.1 UNII
    25X51I8RD4
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 3 Pyridinecarboxamide

    2. 3-pyridinecarboxamide

    3. B 3, Vitamin

    4. B3, Vitamin

    5. Enduramide

    6. Jenapharm, Nicotinsureamid

    7. Niacinamide

    8. Nicobion

    9. Nicotinsureamid Jenapharm

    10. Papulex

    11. Vitamin B 3

    12. Vitamin B3

    13. Vitamin Pp

    2.3.2 Depositor-Supplied Synonyms

    1. Niacinamide

    2. 98-92-0

    3. 3-pyridinecarboxamide

    4. Pyridine-3-carboxamide

    5. Nicotinic Acid Amide

    6. Vitamin Pp

    7. Papulex

    8. Aminicotin

    9. Amixicotyn

    10. Nicobion

    11. Nicotylamide

    12. Nikotinamid

    13. Savacotyl

    14. Benicot

    15. Dipegyl

    16. Endobion

    17. Hansamid

    18. Pelmine

    19. Nicotinic Amide

    20. Delonin Amide

    21. Pelonin Amide

    22. Vi-nicotyl

    23. Austrovit Pp

    24. Inovitan Pp

    25. Nicosylamide

    26. Nicotilamide

    27. Nicotililamido

    28. Amnicotin

    29. Niacevit

    30. Nicamina

    31. Nicamindon

    32. Nicofort

    33. Nicomidol

    34. Nicotamide

    35. Nicovitina

    36. Nicovitol

    37. Nicozymin

    38. Niocinamide

    39. Niozymin

    40. Niamide

    41. Nicasir

    42. Nicogen

    43. Nicota

    44. Nicotol

    45. Nicovit

    46. Niko-tamin

    47. 3-carbamoylpyridine

    48. Nicotine Acid Amide

    49. Nandervit-n

    50. Pyridine-3-carboxylic Acid Amide

    51. Vitamin B

    52. Niavit Pp

    53. Nicotinamidum

    54. Nicosan 2

    55. Nicotine Amide

    56. Beta-pyridinecarboxamide

    57. Nikotinsaeureamid

    58. Nicotylamidum

    59. Mediatric

    60. Nicotinsaureamid

    61. Pyridine, 3-carbamoyl-

    62. 3-pyridinecarboxylic Acid Amide

    63. M-(aminocarbonyl)pyridine

    64. Acid Amide

    65. Factor Pp

    66. Nicotinamida

    67. Nicovel

    68. Vitamin B (van)

    69. Pelmin

    70. Amid Kyseliny Nikotinove

    71. Witamina Pp

    72. Pp-faktor

    73. Amide Pp

    74. Nicotinsaureamid [german]

    75. Nikotinsaeureamid [german]

    76. Amid Kyseliny Nikotinove [czech]

    77. Nicotinamidum [inn-latin]

    78. Nicotinamida [inn-spanish]

    79. Nam

    80. Niacinamid

    81. Nictoamide

    82. Ccris 1901

    83. Dipigyl

    84. Hsdb 1237

    85. Vi-noctyl

    86. Ai3-02906

    87. Nsc 13128

    88. B-pyridinecarboxamide

    89. Niacinamide [usp]

    90. Nicotinamide [inn]

    91. 3-(aminocarbonyl)pyridine

    92. Mfcd00006395

    93. Nsc-13128

    94. Nsc-27452

    95. .beta.-pyridinecarboxamide

    96. Nicotinamide (vitamin B3)

    97. Chembl1140

    98. Mls000069714

    99. Chebi:17154

    100. 25x51i8rd4

    101. Nsc13128

    102. Niacinamide (usp)

    103. Ncgc00093354-03

    104. Ncgc00093354-05

    105. Smr000058212

    106. Nicotinamide 10 Microg/ml In Acetonitrile

    107. Dsstox_cid_929

    108. Niacinamide;nicotinic Acid Amide;vitamin B3

    109. Wln: T6nj Cvz

    110. Dsstox_rid_75873

    111. Dsstox_gsid_20929

    112. Niacinamide [usan]

    113. Enduramide

    114. Cas-98-92-0

    115. B3, Vitamin

    116. Vitamin B 3

    117. B 3, Vitamin

    118. 3 Pyridinecarboxamide

    119. Sr-01000721872

    120. Nicotinsaureamid Jenapharm

    121. Einecs 202-713-4

    122. Jenapharm, Nicotinsaureamid

    123. Niacotinamide

    124. Nicotinamid

    125. Nicotin-amide

    126. Unii-25x51i8rd4

    127. Nicotinsaeureamid

    128. 3-amidopyridine

    129. Dea No. 1405

    130. Nicotinamide,(s)

    131. Vitamin B3 Amide

    132. 3-yridinecarboxamide

    133. Mediatric (salt/mix)

    134. Niacin - Vitamin B3

    135. 1yc5

    136. Opera_id_775

    137. Niacin (as Niacinamide)

    138. Niacinamide [ii]

    139. Niacinamide(vitamin B3)

    140. Niacinamide [fcc]

    141. Nicotinamide [mi]

    142. Niacinamide [hsdb]

    143. Niacinamide [inci]

    144. Nicotinamide [jan]

    145. Bmse000281

    146. Molmap_000061

    147. Ec 202-713-4

    148. Niacinamide [vandf]

    149. Schembl2926

    150. Nicotinamide (jp17/inn)

    151. Nicotinamidum [hpus]

    152. Niacinamide [usp-rs]

    153. Nicotinamide [mart.]

    154. Mls001424246

    155. Nicotinamide [who-dd]

    156. Nicotinamide [who-ip]

    157. Nicotinamide-(amide-[15n])

    158. Schembl6278767

    159. Sgcut00176

    160. Zinc5878

    161. Tpn Component Niacinamide

    162. Dtxsid2020929

    163. Schembl19978192

    164. Bdbm27507

    165. Niacinamide [orange Book]

    166. Nicotinamide, Niacin, Vitamin B3

    167. Hms2052m21

    168. Hms2090b05

    169. Hms2093h03

    170. Hms2236j03

    171. Hms3370f21

    172. Hms3394m21

    173. Hms3655m20

    174. Hms3713b22

    175. Hms3884a16

    176. Nicotinamide [ep Impurity]

    177. Pharmakon1600-01505397

    178. Niacinamide [usp Monograph]

    179. Nicotinamide [ep Monograph]

    180. Bcp07322

    181. Hy-b0150

    182. Niacinamide Component Of Tpn

    183. Nicotinamide (vitamin B3) Solution

    184. Nsc27452

    185. To_000073

    186. Nicotinamide 1.0 Mg/ml In Methanol

    187. Nicotinamide, >=98.5% (hplc)

    188. Nicotinamide, >=99.5% (hplc)

    189. Tox21_111202

    190. Tox21_201716

    191. Tox21_302776

    192. Nicotinamidum [who-ip Latin]

    193. Nsc759115

    194. S1899

    195. Stl163867

    196. Akos005715850

    197. Tox21_111202_1

    198. Ccg-101149

    199. Cs-1968

    200. Db02701

    201. Nc00399

    202. Nsc-759115

    203. Sb74497

    204. Nicotinamide 100 Microg/ml In Methanol

    205. Nicotinamide, >=98% (hplc), Powder

    206. Ncgc00093354-04

    207. Ncgc00093354-06

    208. Ncgc00093354-09

    209. Ncgc00256432-01

    210. Ncgc00259265-01

    211. Niacin (as Niacinamide) [vandf]

    212. As-13845

    213. Bn166252

    214. Nicotinamide, Puriss., 99.0-101.0%

    215. Sy024804

    216. Nicotinamide, Tested According To Ph.eur.

    217. Sbi-0206826.p001

    218. Db-057754

    219. Ft-0631517

    220. Ft-0672696

    221. Ft-0773644

    222. N0078

    223. N1651

    224. Sw197779-3

    225. En300-15612

    226. Niacinamide, Meets Usp Testing Specifications

    227. C00153

    228. D00036

    229. Nicotinamide (niacinamide), Analytical Standard

    230. Ab00373895-13

    231. Ab00373895_15

    232. Ab00373895_16

    233. Nicotinamide, Vetec(tm) Reagent Grade, >=98%

    234. A845925

    235. Ac-907/25014114

    236. Q192423

    237. Q-201470

    238. Sr-01000721872-3

    239. Sr-01000721872-4

    240. Sr-01000721872-5

    241. Z33546463

    242. F2173-0513

    243. Niacinamide;nicotinic Acid Amide;vitamin B3; Vitamin Pp

    244. Nicotinamide, British Pharmacopoeia (bp) Reference Standard

    245. A186b02e-6c70-4e54-9739-79398d439aaa

    246. Nicotinamide, European Pharmacopoeia (ep) Reference Standard

    247. Niacinamide, United States Pharmacopeia (usp) Reference Standard

    248. Niacinamide, Pharmaceutical Secondary Standard; Certified Reference Material

    249. Nicotinamide, Bioreagent, Suitable For Cell Culture, Suitable For Insect Cell Culture

    250. Nicotinamide (vitamin B3) Solution, 1.0 Mg/ml In Methanol, Ampule Of 1 Ml, Certified Reference Material

    2.4 Create Date
    2004-09-16
    3 Chemical and Physical Properties
    Molecular Weight 122.12 g/mol
    Molecular Formula C6H6N2O
    XLogP3-0.4
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count2
    Rotatable Bond Count1
    Exact Mass122.048012819 g/mol
    Monoisotopic Mass122.048012819 g/mol
    Topological Polar Surface Area56 Ų
    Heavy Atom Count9
    Formal Charge0
    Complexity114
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Therapeutic Uses

    Vitamin B Complex

    National Library of Medicine's Medical Subject Headings. Niacinamide. Online file (MeSH, 2018). Available from, as of June 1, 2018: https://www.nlm.nih.gov/mesh/2017/mesh_browser/MBrowser.html

    /CLINICAL TRIALS/ ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. The Web site is maintained by the National Library of Medicine (NLM) and the National Institutes of Health (NIH). Each ClinicalTrials.gov record presents summary information about a study protocol and includes the following: Disease or condition; Intervention (for example, the medical product, behavior, or procedure being studied); Title, description, and design of the study; Requirements for participation (eligibility criteria); Locations where the study is being conducted; Contact information for the study locations; and Links to relevant information on other health Web sites, such as NLM's MedlinePlus for patient health information and PubMed for citations and abstracts for scholarly articles in the field of medicine. Nicotinamide is included in the database.

    NIH/NLM; ClinicalTrials.Gov. Available from, as of June 1, 2018: https://clinicaltrials.gov/

    Niacin and niacinamide are used to prevent niacin deficiency and to treat pellagra. Some clinicians prefer niacinamide for the treatment of pellagra because it lacks vasodilating effects. Pellagra may result from dietary deficiency, isoniazid therapy, or from decreased conversion of tryptophan to niacin in Hartnup disease or carcinoid tumors. /Included in US product label/

    American Society of Health-System Pharmacists 2017; Drug Information 2017. Bethesda, MD. 2017

    Although niacin and niacinamide have not been shown by well-controlled trials to have therapeutic value, the drugs have been used for the management of schizophrenic disorder, drug-induced hallucinations, chronic brain syndrome, hyperkinesis, unipolar depression, motion sickness, alcohol dependence, livedoid vasculitis, acne, and leprosy. /NOT included in US product label/

    American Society of Health-System Pharmacists 2017; Drug Information 2017. Bethesda, MD. 2017

    For more Therapeutic Uses (Complete) data for Nicotinamide (14 total), please visit the HSDB record page.

    4.2 Drug Warning

    Blood glucose concentration should be monitored periodically in patients receiving niacin or niacinamide, especially early in the course of therapy. Dosage requirements for antidiabetic agents (e.g., insulin, oral sulfonylureas) may change in diabetic patients.

    American Society of Health-System Pharmacists 2017; Drug Information 2017. Bethesda, MD. 2017

    Potential adverse effects on fetus: Higher levels in fetus than mother, but no fetal anomalies reported. Potential side effects on breast-fed infant: No adverse effects known . FDA Category: C (C = Studies in laboratory animals have revealed adverse effects on the fetus (teratogenic, embryocidal, etc.), but there are no controlled studies in pregnant women. The benefits from use of the drug in pregnant women may be acceptable despite its potential risks, or there are no laboratory animal studies or adequate studies in pregnant women.) /from table II/

    Stockton, D.L. and A.S. Paller. J Am Acad Dermatol 23 (1):87-103 (1990)

    Niacinamide /was administered/ daily as a liquid formulation to head and neck cancer patients receiving a 5- to 7-week course of radiotherapy. Niacinamide was administered orally 1.5 hr before irradiation. The daily dose was 80 mg/kg bw to a maximum of 6 g. A dose reduction to 60 mg/kg was introduced for patients with severe side-effects. ... Side-effects of niacinamide were monitored. In all patients, peak concentrations greater than 700 nM/mL could be obtained 0.25-3 hr after drug intake. During the first week of treatment, plasma concentrations at the time of irradiation were adequate in 82% of the samples. Nausea, with or without vomiting, occurred in 65% of patients. Tolerance improved after a 25% reduction of the dose in six of seven patients but plasma concentrations at the time of irradiation decreased below 700 nM/mL in four out of six patients. Other niacinamide side effects included gastrointestinal symptoms, flushing, dizziness, sweating, fatigue, and headache. The most powerful single predictor for severe niacinamide toxicity was the mean of the plasma concentration measured at the time of irradiation during the first week.

    Cosmetic Ingredient Review (CIR) Expert Panel; Final Report of the Safety Assessment of Niacinamide and Niacin p.6; Intl J of Toxicology 24 (Suppl 5): 1-31 (2005). Available from, as of June 4, 2018: https://www.cir-safety.org/ingredients

    Abnormal liver function test results (including increased serum concentrations of bilirubin, AST [SGOT], ALT [SGPT], and LDH), jaundice, and chronic liver damage have occurred during niacin and niacinamide therapy. Abnormal prothrombin time and hypoalbuminemia have also been reported.

    American Society of Health-System Pharmacists 2017; Drug Information 2017. Bethesda, MD. 2017

    For more Drug Warnings (Complete) data for Nicotinamide (6 total), please visit the HSDB record page.

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    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
    Adenosine Receptor Agonists [MoA]; Adenosine Receptor Agonist [EPC]
    5.3 ATC Code

    A11HA01

    S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

    A - Alimentary tract and metabolism

    A11 - Vitamins

    A11H - Other plain vitamin preparations

    A11HA - Other plain vitamin preparations

    A11HA01 - Nicotinamide

    5.4 Absorption, Distribution and Excretion

    14(C)Niacinamide was incorporated into an oil-in-water (o/w) skin cream and into a 30% (w/w) soap base and applied to the skin of female Colworth Wistar rats. The final concentration of niacinamide in the soap solution was approximately 0.3% (w/v) and was 1% (w/w) in the skin cream. Application of the skin cream and soap paste was made to rat skin at approximately 20 mg/sq cm. The cream was carefully massaged over 10 sq cm of skin for up to 5 min before covering with polythene-lined occlusive protective patches. The rats were placed in metabolism cages for 48 hr during which time all excreta was collected. At 48 hr, the animals were killed and the patch, carcass, and treated area of skin were assayed for 14(C). Up to 32% 14(C) was recovered in excreta and in the carcasses from rats treated with skin cream containing 14(C)Niacinamide and up to 30% from those treated with soap paste.

    Cosmetic Ingredient Review (CIR) Expert Panel; Final Report of the Safety Assessment of Niacinamide and Niacin p.5; Intl J of Toxicology 24 (Suppl 5): 1-31 (2005). Available from, as of June 4, 2018: https://www.cir-safety.org/ingredients

    Nicotinamide is efficiently absorbed from the gastrointestinal tract. At low doses, absorption is mediated via sodium-dependent facilitated diffusion. Passive diffusion is the principal mechanism of absorption at higher doses. Doses of up to three to four grams of nicotinamide are almost completely absorbed. Nicotinamide is transported via the portal circulation to the liver and via the systemic circulation to the various tissues of the body. Nicotinamide enters most cells by passive diffusion and enters erythrocytes by facilitated transport.

    PDR for Nutritional Supplements 2nd ed. Thomson Reuters, Montvale, NJ 2008, p. 452

    Niacinamide is widely distributed /throughout/ body tissues.

    American Society of Health-System Pharmacists 2017; Drug Information 2017. Bethesda, MD. 2017

    Niacin and niacinamide are readily absorbed from the GI tract following oral administration, and niacinamide (no longer commercially available in the US) is readily absorbed from subcutaneous and IM injection sites.

    American Society of Health-System Pharmacists 2017; Drug Information 2017. Bethesda, MD. 2017

    For more Absorption, Distribution and Excretion (Complete) data for Nicotinamide (16 total), please visit the HSDB record page.

    5.5 Metabolism/Metabolites

    In amounts needed for physiologic function as a coenzyme (12-18 mg daily), niacin is converted to niacinamide; larger doses of niacin are converted to niacinamide to only a minor degree. Niacinamide is metabolized in the liver to N-methylniacinamide, other N-methylated derivatives, and nicotinuric acid (the glycine conjugate of niacin). These metabolites are excreted in urine. Following administration of physiologic doses of niacin or niacinamide, only a small amount of niacinamide is excreted unchanged in urine; however, following administration of larger doses, a greater proportion of niacin and niacinamide is excreted unchanged.

    American Society of Health-System Pharmacists 2017; Drug Information 2017. Bethesda, MD. 2017

    N1-Methyl-4-pyridone-3-carboxamide was detected on chromatograms of plasma extracts after oral administration of niacinamide to two human subjects.

    Cosmetic Ingredient Review (CIR) Expert Panel; Final Report of the Safety Assessment of Niacinamide and Niacin p.6; Intl J of Toxicology 24 (Suppl 5): 1-31 (2005). Available from, as of June 4, 2018: https://www.cir-safety.org/ingredients

    6-Hydroxynicotinamide and 6-hydroxynicotinic acid /were detected/ as urinary metabolites by comparison of ultraviolet, infrared, and mass spectra following intraperitoneal injections of 14(C)Niacin or 14(C)Niacinamide into rats.

    Cosmetic Ingredient Review (CIR) Expert Panel; Final Report of the Safety Assessment of Niacinamide and Niacin p.8; Intl J of Toxicology 24 (Suppl 5): 1-31 (2005). Available from, as of June 4, 2018: https://www.cir-safety.org/ingredients

    N1-methyl-4- pyridone-3-carboxamide is a major metabolite of niacin and niacinamide which has been found to be synthesized from N1- methylnicotinamide.

    Cosmetic Ingredient Review (CIR) Expert Panel; Final Report of the Safety Assessment of Niacinamide and Niacin p.8; Intl J of Toxicology 24 (Suppl 5): 1-31 (2005). Available from, as of June 4, 2018: https://www.cir-safety.org/ingredients

    For more Metabolism/Metabolites (Complete) data for Nicotinamide (7 total), please visit the HSDB record page.

    5.6 Biological Half-Life

    The mean half life values were 2.7 hr, 5.9 hr, and 8.1 hr after taking 1, 3, or 6 g of Niacinamide, respectively.

    Cosmetic Ingredient Review (CIR) Expert Panel; Final Report of the Safety Assessment of Niacinamide and Niacin p.6; Intl J of Toxicology 24 (Suppl 5): 1-31 (2005). Available from, as of June 4, 2018: https://www.cir-safety.org/ingredients

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    DOSAGE - FOR SOLUTION;INTRAVENOUS - 80MG/VIAL...DOSAGE - FOR SOLUTION;INTRAVENOUS - 80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL;17MG/VIAL;0.2MG/VIAL;1MG/VIAL;1.4MG/VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/VIAL

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    DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/...DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML

    USFDA APPLICATION NUMBER - 21163

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    DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/...DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML

    USFDA APPLICATION NUMBER - 21163

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    ABOUT THIS PAGE

    Looking for 98-92-0 / Nicotinamide API manufacturers, exporters & distributors?

    Nicotinamide manufacturers, exporters & distributors 1

    52

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

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

    PharmaCompass also assists you with knowing the Nicotinamide API Price utilized in the formulation of products. Nicotinamide API Price is not always fixed or binding as the Nicotinamide Price is obtained through a variety of data sources. The Nicotinamide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Nicotinamide

    Synonyms

    Niacinamide, 98-92-0, 3-pyridinecarboxamide, Pyridine-3-carboxamide, Nicotinic acid amide, Vitamin pp

    Cas Number

    98-92-0

    Unique Ingredient Identifier (UNII)

    25X51I8RD4

    About Nicotinamide

    An important compound functioning as a component of the coenzyme NAD. Its primary significance is in the prevention and/or cure of blacktongue and PELLAGRA. Most animals cannot manufacture this compound in amounts sufficient to prevent nutritional deficiency and it therefore must be supplemented through dietary intake.

    Nicotamide Manufacturers

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

    Nicotamide Suppliers

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

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

    Nicotamide USDMF

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

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

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

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

    Nicotamide KDMF

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

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

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

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

    Nicotamide CEP

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

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

    Nicotamide WC

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

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

    Nicotamide 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 Nicotamide as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Nicotamide GMP

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

    Nicotamide CoA

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

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

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