Synopsis
Synopsis
0
EU WC
0
VMF
0
Australia
DRUG PRODUCT COMPOSITIONS0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
1. Biodermatin
2. Biokur
3. Biotin Gelfert
4. Biotin Hermes
5. Biotin Ratiopharm
6. Biotin-ratiopharm
7. Biotine Roche
8. Deacura
9. Gabunat
10. Gelfert, Biotin
11. Hermes, Biotin
12. Medebiotin
13. Medobiotin
14. Roche, Biotine
15. Rombellin
16. Vitamin H
1. D-biotin
2. 58-85-5
3. Vitamin H
4. Vitamin B7
5. Coenzyme R
6. Bioepiderm
7. Bios Ii
8. Factor S
9. D(+)-biotin
10. Biodermatin
11. D-(+)-biotin
12. Medebiotin
13. (+)-biotin
14. Biotinum
15. Biotine
16. Meribin
17. Factor S (vitamin)
18. Lutavit H2
19. Biotina
20. 3h-biotin
21. Nsc 63865
22. Ccris 3932
23. Hsdb 346
24. Ritatin
25. Injacom H
26. 5-((3as,4s,6ar)-2-oxohexahydro-1h-thieno[3,4-d]imidazol-4-yl)pentanoic Acid
27. Cis-hexahydro-2-oxo-1h-thieno(3,4)imidazole-4-valeric Acid
28. Cis-tetrahydro-2-oxothieno(3,4-d)imidazoline-4-valeric Acid
29. L-biotin
30. 1swk
31. 1swn
32. 1swr
33. Mfcd00005541
34. Rovimix H 2
35. D-biotin Factor S
36. 5-[(3as,4s,6ar)-2-oxo-hexahydro-1h-thieno[3,4-d]imidazolidin-4-yl]pentanoic Acid
37. Ai3-51198
38. 5-[(3as,4s,6ar)-2-oxohexahydro-1h-thieno[3,4-d]imidazol-4-yl]pentanoic Acid
39. 5-[(3as,4s,6ar)-2-oxo-1,3,3a,4,6,6a-hexahydrothieno[3,4-d]imidazol-4-yl]pentanoic Acid
40. Cis-(+)-tetrahydro-2-oxothieno[3,4]imidazoline-4-valeric Acid
41. (+)-cis-hexahydro-2-oxo-1h-thieno[3,4]imidazole-4-valeric Acid
42. (3as,4s,6ar)-hexahydro-2-oxo-1h-thieno(3,4-d)imidazole-4-valeric Acid
43. 1h-thieno(3,4-d)imidazole-4-pentanoic Acid, Hexahydro-2-oxo-, (3as-(3aalpha,4beta,6aalpha))-
44. 2'-keto-3,4-imidazolido-2-tetrahydrothiophene-n-valeric Acid
45. Chebi:15956
46. 6so6u10h04
47. 1h-thieno[3,4-d]imidazole-4-pentanoic Acid, Hexahydro-2-oxo-, (3as,4s,6ar)-
48. Nsc-63865
49. Hexahydro-2-oxo-1h-thieno(3,4-d)imidazole-4-pentanoic Acid, (3as-(3aalpha,4beta,6aalpha))-
50. 22377-59-9
51. D-biotin 10 Microg/ml In Acetonitrile
52. Md-1003
53. Beta-biotin
54. Biotin Impurity D - Mixture Of Diastereomers
55. Dsstox_cid_2679
56. Vitamin Bw
57. (3as,4s,6ar)-hexahydro-2-oxo-1h-thieno[3,4-d]imidazole-4-valeric Acid
58. (3as-(3aalpha,4b,6aalpha))-hexahydro-2-oxo-1h-thieno(3,4-d)imidaz- Ole-4-pentanoic Acid
59. Dsstox_rid_76688
60. Dsstox_gsid_22679
61. Medobiotin
62. Deacura
63. Gabunat
64. Hexahydro-2-oxo-1h-thieno(3,4-d)imidazole-4-pentanoic Acid
65. Rombellin
66. Biokur
67. Biotine [inn-french]
68. Biotinum [inn-latin]
69. Biotina [inn-spanish]
70. Biotin Gelfert
71. Biotin Hermes
72. Biotine Roche
73. Gelfert, Biotin
74. Biotin Ratiopharm
75. Biotin-ratiopharm
76. Hermes, Biotin
77. Roche, Biotine
78. 1h-thieno(3,4-d)imidazole-4-pentanoic Acid, Hexahydro-2-oxo-, (3as,4s,6ar)-
79. 5-((3as,4s,6ar)-rel-2-oxohexahydro-1h-thieno[3,4-d]imidazol-4-yl)pentanoic Acid
80. Smr000112255
81. D(+)biotin
82. 5-(2-oxohexahydro-1h-thieno[3,4-d]imidazol-4-yl)pentanoic Acid
83. Einecs 200-399-3
84. Biotin [usp:inn:jan]
85. Hexahydro-2-oxo-1h-thieno[3,4-d]imidazole-4-pentanoic Acid
86. Unii-6so6u10h04
87. Delta-biotin
88. Vitamin-h
89. 1avd
90. 1ndj
91. 1stp
92. 1swg
93. 1swp
94. 2avi
95. 4bcs
96. 4ggz
97. 4jnj
98. Bioepiderm (tn)
99. Cas-58-85-5
100. Bios H
101. Ncgc00094984-04
102. 1h-thieno[3,4-d]imidazole-4-pentanoic Acid, Hexahydro-2-oxo-, [3as-(3aalpha,4beta,6aalpha)]-
103. Biotin111in
104. Delta-(+)-biotin
105. Biotin (8ci)
106. Delta-biotin Factor S
107. 1df8
108. 1n9m
109. 2gh7
110. 3t2w
111. 4bj8
112. Biotin [vandf]
113. Biotin [hsdb]
114. Biotin [inci]
115. Biotin [fcc]
116. Biotin [inn]
117. Biotin [jan]
118. Biotin [usp-rs]
119. Biotin [who-dd]
120. Prestwick0_000418
121. Prestwick1_000418
122. Prestwick2_000418
123. Prestwick3_000418
124. Biotin [mi]
125. Biotin [mart.]
126. Cid_253
127. D-biotin [vandf]
128. Bdbm12
129. Biotin Silver Nanoparticles
130. Bmse000227
131. Chembl857
132. Probes2_000006
133. Schembl8763
134. Biotin [ep Impurity]
135. Biotin [orange Book]
136. Biotin For System Suitability
137. Bspbio_000376
138. 22879-79-4
139. Biotin (jp17/usp/inn)
140. Mls001066402
141. Mls001074888
142. Mls001331736
143. Mls001333089
144. Biotin [ep Monograph]
145. D-biotin, Analytical Standard
146. Spbio_002315
147. Biotin [usp Monograph]
148. Bpbio1_000414
149. Cid_171548
150. Gtpl4787
151. Amf0005
152. 1n43
153. 2f01
154. Biotin, >=99.0% (t)
155. Hms1569c18
156. Hms2096c18
157. Hms2271o06
158. Hms3713c18
159. Hy-b0511
160. Tox21_113050
161. Tox21_302161
162. Ac8089
163. Bbl028095
164. Biotin, Tested According To Ph.eur.
165. S3130
166. Stk801941
167. Zinc35024346
168. Akos001287669
169. Tox21_113050_1
170. Ccg-220418
171. Db00121
172. 1h-thieno(3,4-d)imidazole-4-pentanoic Acid, Hexahydro-2-oxo-, (3as-(3aalpha,4b,6aalpha))-
173. Biotin, Meets Usp Testing Specifications
174. Biotin, Saj Special Grade, >=98.0%
175. Ncgc00179580-01
176. Ncgc00179580-02
177. Ncgc00179580-04
178. Ncgc00255377-01
179. 56846-45-8
180. Ac-19998
181. Bp-20441
182. Biotin, >=99% (tlc), Lyophilized Powder
183. Biotin, Vetec(tm) Reagent Grade, >=99%
184. Ab00374191
185. B0463
186. 58b855
187. C00120
188. D00029
189. M02926
190. Ab00374191-08
191. Ab00374191_11
192. A929752
193. Biotin, Plant Cell Culture Tested, >=99% (tlc)
194. Q181354
195. Sr-01000765521
196. Biotin, Certified Reference Material, Tracecert(r)
197. Q-200929
198. Sr-01000765521-2
199. Brd-k89210380-001-03-8
200. Brd-k89210380-001-13-7
201. 6ae43aa3-bc3d-4c49-9db9-5913a2401eb6
202. Biotin, European Pharmacopoeia (ep) Reference Standard
203. F2173-0855
204. Hexahydro-2-oxo-1h-thieno(3,4-d)imidazole-4-pentanoate
205. Z210803762
206. Biotin, United States Pharmacopeia (usp) Reference Standard
207. Cis-(+)-tetrahydro-2-oxothieno[3,4]imidazoline-4-valerate
208. (+)-cis-hexahydro-2-oxo-1h-thieno[3,4]imidazole-4-valerate
209. 5-(2-oxohexahydro-1h-thieno[3,4-d]imidazol-4-yl)pentanoate
210. Daunorubicin Hydrochloride, Antibiotic For Culture Media Use Only
211. (3as,4s,6ar)-hexahydro-2-oxo-1h-thieno[3,4-d]imidazole-4-valerate
212. Biotin, Pharmaceutical Secondary Standard; Certified Reference Material
213. 1h-thieno[3,4-d]imidazole-4-pentanoic Acid, Hexahydro-2-oxo-, (3as,4s,6ar)- (9ci)
214. 5-((3ar,6s,6as)-2-oxo-hexahydro-thieno[3,4-d]imidazol-6-yl)-pentanoic Acid
215. 5-[(3ar,6s,6as)-2-oxo-1,3,3a,4,6,6a-hexahydrothieno[3,4-d]imidazol-6-yl]pentanoic Acid
216. Biotin For System Suitability, European Pharmacopoeia (ep) Reference Standard
217. Hexahydro-2-oxo-[3as-(3aa,4b,6aa)]-1h-thieno[3,4-d]imidazole-4-pentanoate
218. Hexahydro-2-oxo-[3as-(3aa,4b,6aa)]-1h-thieno[3,4-d]imidazole-4-pentanoic Acid
219. Hexahydro-2-oxo-[3as-(3alpha,4beta,6alpha)]-1h-thieno[3,4-d]imidazole-4-pentanoate
220. Hexahydro-2-oxo-[3as-(3alpha,4beta,6alpha)]-1h-thieno[3,4-d]imidazole-4-pentanoic Acid
221. Biotin, Pharmagrade, Usp, Meets Fcc Testing Specifications, Manufactured Under Appropriate Gmp Controls For Pharma Or Biopharmaceutical Production.
222. Biotin, Powder, Bioreagent, Suitable For Cell Culture, Suitable For Insect Cell Culture, Suitable For Plant Cell Culture, >=99%
| Molecular Weight | 244.31 g/mol |
|---|---|
| Molecular Formula | C10H16N2O3S |
| XLogP3 | 0.3 |
| Hydrogen Bond Donor Count | 3 |
| Hydrogen Bond Acceptor Count | 4 |
| Rotatable Bond Count | 5 |
| Exact Mass | 244.08816355 g/mol |
| Monoisotopic Mass | 244.08816355 g/mol |
| Topological Polar Surface Area | 104 Ų |
| Heavy Atom Count | 16 |
| Formal Charge | 0 |
| Complexity | 298 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 3 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
The B vitamins are indicated for prevention and treatment of vitamin B deficiency. Vitamin B deficiency may occur as a result of inadequate nutrition or intestinal malabsorption but does not occur in healthy individuals receiving an adequate balanced diet. Simple nutritional deficiency of individual B vitamins is rare since dietary inadequacy usually results in multiple deficiencies. For prophylaxis of biotin deficiency, dietary improvement, rather than supplementatin, is advisable. For teatment of biotin deficiency, supplementation is preferred. /Included in US product labeling/
Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007.
Large doses of biotin ... are administered to babies with infantile seborrhea and to individuals with genetic alterations of biotin-dependent enzymes. patients who receive long-term parenteral nutrition should be given vitamin formulations that contain biotin.
Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 1763
(VET): Biotin is used as a feed additive for poultry and swine.
Kirk-Othmer Encyclopedia of Chemical Technology. 3rd ed., Volumes 1-26. New York, NY: John Wiley and Sons, 1978-1984., p. V24 41
Biotin is used to treat the biotin-responsive inborn errors of metabolism holocarboxylase synthetase deficiency and biotinidase deficiency. Holocarboxylase deficiency is the most common cause of neonatal multiple carboxylase deficiency. Biotinidase deficiency is the most common cause of late-onset multiple carboxylase deficiency.
Physicians Desk Reference (PDR) for Nutritional Supplements 1st ed, Medical Economics, Thomson Healthcare; Montvale, NJ p.52 (2001)
For more Therapeutic Uses (Complete) data for BIOTIN (11 total), please visit the HSDB record page.
Biotin deficiency, which can occur by the feeding of uncooked egg whites or by the omission of biotin from the diet, can cause alopecia and a characteristic scaly, erythematous dermatitis around body orifices in infants, children, and adults. For adults, prolonged biotin deficiency can result in depression, lethargy, hallucinations, and paresthesias of the extremities.
PMID:11800048 Fiume MZ, Cosmetic Ingredient Review Expert Panel; Int J Toxicol 20 (Suppl 4):1-12 (2001)
Biotin has not been proven effective in the treatment of acne, seborrheic eczema, or alopecia.
Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007.
For nutritional supplementation, also for treating dietary shortage or imbalance.
Treatment of multiple sclerosis
Biotin is a water-soluble B-complex vitamin which is composed of an ureido ring fused with a tetrahydrothiophene ring, which attaches a valeric acid substituent at one of its carbon atoms. Biotin is used in cell growth, the production of fatty acids, metabolism of fats, and amino acids. It plays a role in the Kreb cycle, which is the process in which energy is released from food. Biotin not only assists in various metabolic chemical conversions, but also helps with the transfer of carbon dioxide. Biotin is also helpful in maintaining a steady blood sugar level. Biotin is often recommended for strengthening hair and nails. Consequenty, it is found in many cosmetic and health products for the hair and skin. Biotin deficiency is a rare nutritional disorder caused by a deficiency of biotin. Initial symptoms of biotin deficiency include: Dry skin, Seborrheic dermatitis, Fungal infections, rashes including erythematous periorofacial macular rash, fine and brittle hair, and hair loss or total alopecia. If left untreated, neurological symptoms can develop, including mild depression, which may progress to profound lassitude and, eventually, to somnolence; changes in mental status, generalized muscular pains (myalgias), hyperesthesias and paresthesias. The treatment for biotin deficiency is to simply start taking some biotin supplements. A lack of biotin in infants will lead to a condition called seborrheic dermatitis or "cradle cap". Biotin deficiencies are extremely rare in adults but if it does occur, it will lead to anemia, depression, hair loss, high blood sugar levels, muscle pain, nausea, loss of appetite and inflamed mucous membranes.
Vitamin B Complex
A group of water-soluble vitamins, some of which are COENZYMES. (See all compounds classified as Vitamin B Complex.)
A - Alimentary tract and metabolism
A11 - Vitamins
A11H - Other plain vitamin preparations
A11HA - Other plain vitamin preparations
A11HA05 - Biotin
Absorption
Systemic - approximately 50%
The intestine is exposed to biotin from a few sources: the diet, biotin supplements and biotin synthesized by bacteria in the large intestine. Dietary biotin exists in free and protein-bound forms. Protein-bound biotin is digested by proteases and peptidases to biotin-containing oligopeptides and biocytin (epsilon-N-biotinyl-L-lysine). Biocytin and the biotin-containing oligopeptides are converted to biotin via the enzyme biotinidase. Biotin - both dietary-derived biotin and supplementary biotin - is efficiently absorbed from the small intestine. At doses of biotin derived from food, biotin appears to be transported into enterocytes by a sodium -dependent carrier. At higher doses of biotin,absorption appears to occur by passive diffusion. Absorption of the biotin produced by the colonic microflora, appears to occur by a carrier mediated process in the proximal large intestine.
Physicians Desk Reference (PDR) for Nutritional Supplements 1st ed, Medical Economics, Thomson Healthcare; Montvale, NJ p.52 (2001)
Elimination: Primarily in urine.
Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007.
Protein binding: Primarily to plasma proteins.
Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006.
Absorption: approximately 50%.
Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006.
For more Absorption, Distribution and Excretion (Complete) data for BIOTIN (32 total), please visit the HSDB record page.
Biotin is excreted in the urine as biotin, bisnorbiotin, biotin sulfoxide, biotin sulfone, bisnorbiotin methyl ketone and tetranobiotin-1-sulfoxide.
Physicians Desk Reference (PDR) for Nutritional Supplements 1st ed, Medical Economics, Thomson Healthcare; Montvale, NJ p.52 (2001)
Biotin is catabolized to a number of different metabolites, including bisnorbiotin, biotin sulfoxide, biotin sulfone, bisonorbiotin methylketone and tetranorbiotin-1-sulfoxide.
Physicians Desk Reference (PDR) for Nutritional Supplements 1st ed, Medical Economics, Thomson Healthcare; Montvale, NJ p.52 (2001)
More than 95% of the biotin is free in the skim fraction of human milk. The concentration of biotin varies substantially in some women and exceeds that in serum by one to two order of magnitude, suggesting that there is a transport system into milk. The biotin metabolite bisnorbiotin accounts for approximately 50%. In early and transitional human milk, the biotin metabolite biotin sulfoxide accounts for about 10% of the total biotin plus metabolites. With postpartum maturation, the biotin concentration increases, but the bisnorbiotin and biotin sulfoxide concentrations still account for 25% and 8% at 5 weeks postpartum. Current studies provide no evidence for a soluble biotin-binding protein or any other mechanism that traps biotin in human milk.
Coates, P.M., Blackman, M.R., Cragg, G.M., Levine, M., Moss, J., White, J.D. (Ed), Encyclopedia of Dietary Supplements. Marcel Dekker, New York, NY, p. 35 (2005)
On a molar basis, biotin accounts for approximately half of the total avidin-binding substances in human serum and urine. Biocytin, bisnorbiotin, bisnorbiotin methylketone, biotin sulfoxide, and biotin sulfone form most of the balance. Biotin metabolism is accelerated in some individuals by anticonvulsants and during pregnancy, thereby increasing the ratio of biotin metabolites to biotin excreted in urine.
Coates, P.M., Blackman, M.R., Cragg, G.M., Levine, M., Moss, J., White, J.D. (Ed), Encyclopedia of Dietary Supplements. Marcel Dekker, New York, NY, p. 35 (2005)
An alternate fate to being incorporated into carboxylases or unchanged excretion is catabolism to an inactive metabolite before excretion in urine. About half of biotin undergoes metabolism before excretion. Two principal pathways of biotin catabolism have been identified in mammals. In the first pathway, the valeric acid side chain of biotin is degraded by beta oxidation. This leads to the formation of bisnorbiotin, tetranorbiotin, and related intermediates that are known to result from beta-oxidation of fatty acids. The cellular site of this beta-oxidation of biotin is uncertain. Nonenzymatic decarboxylation of the unstable beta-ketobiotin and beta-keto-bisnorbiotin leads to formation of bisnorbiotin methylketone and tetranorbiotin methylketone, which appear in urine. In the second pathway, the sulfur in the thiophane ring of biotin is oxidized, leading to the formation of biotin L-sulfoxide, biotin D-sulfoxide, and biotin sulfone. Combined oxidation of the ring sulfur and beta-oxidation of the side chain lead to metabolites such as bisnorbiotin sulfone. In mammals, degradation of the biotin ring to release carbon dioxide and urea is quantitatively minor.
Coates, P.M., Blackman, M.R., Cragg, G.M., Levine, M., Moss, J., White, J.D. (Ed), Encyclopedia of Dietary Supplements. Marcel Dekker, New York, NY, p. 35 (2005)
Biotin is necessary for the proper functioning of enzymes that transport carboxyl units and fix carbon dioxide, and is required for various metabolic functions, including gluconeogenesis, lipogenesis, fatty acid biosynthesis, propionate metabolism, and catabolism of branched-chain amino acids.
In human tissues biotin is a cofactor for the enzymatic carboxylation of four substrates: pyruvate, acetyl coenzyme A (CoA), propionyl CoA, and beta-methylcrotonyl CoA. As such, it plays an important role in both carbohydrate and fat metabolism. Carbon dioxide fixation occurs in a two-step reaction, the first involving binding of carbon dioxide to the biotin moiety of the holoenzyme, and the second involving transfer of the biotin-bound carbon dioxide to an appropriate acceptor.
Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 1763
Biotin functions in carbon dioxide fixation reactions in intermediate metabolism, transferring the carboxyl group to acceptor molecules. It acts similarly in decarboxylation reactions. Biotin is essential in human metabolism for its part in the previously described enzymatic steps, in catalyzing deamination of amino acids, and in oleic acid synthesis. Biotin is a cofactor for the enzymatic carboxylation of pyruvate, acetyl coenzyme A (CoA), propionyl CoA, and beta-methylcrotonyl CoA, and, therefore, plays an important role in carbohydrate and fat metabolism.
PMID:11800048 Fiume MZ, Cosmetic Ingredient Review Expert Panel; Int J Toxicol 20 (Suppl 4):1-12 (2001)
Protein folding in the endoplasmic reticulum (ER) depends on Ca2+; uptake of Ca2+ into the ER is mediated by sarco/endoplasmic reticulum Ca2+-ATPase 3 (SERCA3). The 5'-flanking region of the SERCA3 gene (ATP2A3) contains numerous binding sites for the transcription factors Sp1 and Sp3. Biotin affects the nuclear abundance of Sp1 and Sp3, which may act as transcriptional activators or repressors. Here we determined whether biotin affects the expression of the SERCA3 gene and, thus, protein folding in human lymphoid cells. Jurkat cells were cultured in media containing 0.025 nmol/L biotin (denoted "deficient") or 10 nmol/L biotin ("supplemented"). The transcriptional activity of the full-length human SERCA3 promoter was 50% lower in biotin-supplemented cells compared to biotin-deficient cells. Biotin-dependent repressors bind to elements located 731 to 1312 bp upstream from the transcription start site in the SERCA3 gene. The following suggest that low expression of SERCA3 in biotin-supplemented cells impaired folding of secretory proteins in the ER, triggering unfolded protein response: (i) sequestration of Ca2+ in the ER decreased by 14 to 24% in response to biotin supplementation; (ii) secretion of interleukin-2 into the extracellular space decreased by 75% in response to biotin supplementation; (iii) the nuclear abundance of stress-induced transcription factors increased in response to biotin supplementation; and (iv) the abundance of stress-related proteins such ubiquitin activating enzyme 1, growth arrest and DNA damage 153 gene, X-box binding protein 1 and phosphorylated eukaryotic translation initiation factor 2alpha increased in response to biotin supplementation. Collectively, this study suggests that supplements containing pharmacological doses of biotin may cause cell stress by impairing protein folding in the ER.
PMID:16109482 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1473219 Griffin JB et al; J Nutr Biochem 17(4):272-81 (2006)
Evidence is emerging that biotin participates in processes other than classical carboxylation reactions. Specifically, novel roles for biotin in cell signaling, gene expression, and chromatin structure have been identified in recent years. Human cells accumulate biotin by using both the sodium-dependent multivitamin transporter and monocarboxylate transporter 1. These transporters and other biotin-binding proteins partition biotin to compartments involved in biotin signaling: cytoplasm, mitochondria, and nuclei. The activity of cell signals such as biotinyl-AMP, Sp1 and Sp3, nuclear factor (NF)-kappaB, and receptor tyrosine kinases depends on biotin supply. Consistent with a role for biotin and its catabolites in modulating these cell signals, greater than 2000 biotin-dependent genes have been identified in various human tissues. Many biotin-dependent gene products play roles in signal transduction and localize to the cell nucleus, consistent with a role for biotin in cell signaling. Posttranscriptional events related to ribosomal activity and protein folding may further contribute to effects of biotin on gene expression. Finally, research has shown that biotinidase and holocarboxylase synthetase mediate covalent binding of biotin to histones (DNA-binding proteins), affecting chromatin structure; at least seven biotinylation sites have been identified in human histones. Biotinylation of histones appears to play a role in cell proliferation, gene silencing, and the cellular response to DNA repair. Roles for biotin in cell signaling and chromatin structure are consistent with the notion that biotin has a unique significance in cell biology.
PMID:16011464 Zempleni J; Annu Rev Nutr 25:175-96 (2005)
API SUPPLIERS
Basic Nutrition, your expert for sourcing from China, India and Europe.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-02-01
Pay. Date : 2017-01-10
DMF Number : 30157
Submission : 2016-01-13
Status : Active
Type : II
Certificate Number : CEP 2001-405 - Rev 07
Issue Date : 2025-07-11
Type : Chemical
Substance Number : 1073
Status : Valid
Registration Number : 217MF11122
Registrant's Address : Wurmisweg 576, CH-4303, Kaiseraugst, Switzerland
Initial Date of Registration : 2005-12-05
Latest Date of Registration :
NDC Package Code : 63238-3150
Start Marketing Date : 2022-12-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3054
Submission : 1977-11-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4529
Submission : 1982-05-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9706
Submission : 1992-05-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8820
Submission : 1990-11-09
Status : Inactive
Type : II
Certificate Number : R0-CEP 2019-320 - Rev 00
Issue Date : 2021-08-09
Type : Chemical
Substance Number : 1073
Status : Valid
NDC Package Code : 67421-002
Start Marketing Date : 2025-05-30
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Otran Korea Co., Ltd.
Registration Date : 2021-10-19
Registration Number : 20211019-211-J-1124
Manufacturer Name : Zhejiang Shengda Bio-Pharm Co., Ltd.
Manufacturer Address : No.789, Renmin East Road, Tiantai, Zhejiang, China, 317200
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8820
Submission : 1990-11-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3054
Submission : 1977-11-17
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-01
Pay. Date : 2017-01-10
DMF Number : 30157
Submission : 2016-01-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9706
Submission : 1992-05-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4529
Submission : 1982-05-05
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39548
Submission : 2024-02-18
Status : Active
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
Certificate Number : CEP 2001-405 - Rev 07
Status : Valid
Issue Date : 2025-07-11
Type : Chemical
Substance Number : 1073
Certificate Number : R0-CEP 2019-320 - Rev 00
Status : Valid
Issue Date : 2021-08-09
Type : Chemical
Substance Number : 1073
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
Registration Number : 217MF11122
Registrant's Address : Wurmisweg 576, CH-4303, Kaiseraugst, Switzerland
Initial Date of Registration : 2005-12-05
Latest Date of Registration : 2006-11-15
Registration Number : 217MF10344
Registrant's Address : 29-3 Shinmachi, Yashio City, Saitama Prefecture
Initial Date of Registration : 2005-07-27
Latest Date of Registration : 2006-03-24
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
Registrant Name : Otran Korea Co., Ltd.
Registration Date : 2021-10-19
Registration Number : 20211019-211-J-1124
Manufacturer Name : Zhejiang Shengda Bio-Pharm C...
Manufacturer Address : No.789, Renmin East Road, Tiantai, Zhejiang, China, 317200
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
NDC Package Code : 84824-003
Start Marketing Date : 2024-10-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 84824-003
Start Marketing Date : 2024-10-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 90027-019
Start Marketing Date : 2022-09-20
End Marketing Date : 2027-05-28
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 63238-3150
Start Marketing Date : 2022-12-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 63238-3150
Start Marketing Date : 2017-12-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 10695-306
Start Marketing Date : 2025-03-26
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 10695-306
Start Marketing Date : 2025-03-26
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 67421-002
Start Marketing Date : 2025-05-30
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 83511-009
Start Marketing Date : 2024-12-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
NDC Package Code : 10695-325
Start Marketing Date : 2025-09-24
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
Basic Nutrition, your expert for sourcing from China, India and Europe.
About the Company : As an ISO9001, ISO22000 certificated supplier, Basic Nutrition supply high-quality ingredients for nutraceuticals. We can offer a range of products from small to large quantites: h...
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
About the Company : Cerata Pharmaceuticals LLP was established by Mr. Pratik Kansara and Mr. Darshan with a grand vision of being the “most preferred supply partner to pharmaceutical customers world...
About the Company : HANGZHOU THINK CHEMICAL CO., LTD. (THINKCHEM) is an integrative corporation of trade, research and contract manufacture. With about ten years of business experiences on the marketi...
About the Company : Jiangxi Tianxin Pharmaceutical Co.,Ltd. was established in 2004, it is hi-tech enterprise of China, located in Le'anjiang Industrial Zone, Leping, China and close to national highw...
About the Company : We are specialized in manufacturing of Non Pareil Seeds, Active Drug Coated (AC), Enteric Coated (EC), Sustained Release (SR), Delayed Release (DR), Time Release (TR) Extended Rele...
About the Company : Royal DSM, founded in 1902, is a global, purpose-led health, nutrition, and bioscience company that specializes in human and animal health and nutrition solutions. Its primary goal...
About the Company : Benepure is a global research, manufacture and supplier of ingredients and their derivatives for healthcare industry. It owns strong research and development team, cutting-edge equ...
About the Company : Superior Supplement Manufacturing provides comprehensive solutions for all your supplement needs, including capsules, tablets, powders, liquids, and soft gels, as well as high-grad...
About the Company : 30+ year old company possessing and continuously innovating its expertise in Stabilized Vitamins, Herbal Extracts & Formulations, Food Supplements, Tasteless Minerals and API's. Ou...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
Upgrade, download data, analyse, strategize, subscribe with us 
Drugs in Development
Details:
Nu Nutridac, a clinically proven nutritional replenisher designed to support patients with neurodegenerative conditions and anxiety-related disorders.
Lead Product(s): Panax Ginseng Extract,Ginkgo Biloba,Benfotiamine | Pyridoxal 5-phosphate | L-Methyl Folate | Chromium Picolinate | Biotin | Vitamin B12,Benfotiamine,Pyridoxal Phosphate,Levomefolate Calcium,Chromium Picolinate,Biotin,Vitamin B12
Therapeutic Area: Psychiatry/Psychology Brand Name: Nu Nutridac
Study Phase: Approved FDFProduct Type: Plant Extract/Herbal
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 16, 2025
Lead Product(s) : Panax Ginseng Extract,Ginkgo Biloba,Benfotiamine | Pyridoxal 5-phosphate | L-Methyl Folate | Chromium Picolinate | Biotin | Vitamin B12,Benfotiamine,Pyridoxal Phosphate,Levomefolate Calcium,Chromium Picolinate,Biotin,Vitamin B12
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Cadila Pharmaceuticals launches Nu Nutridac capsule for anxiety-related disorders
Details : Nu Nutridac, a clinically proven nutritional replenisher designed to support patients with neurodegenerative conditions and anxiety-related disorders.
Product Name : Nu Nutridac
Product Type : Plant Extract/Herbal
Upfront Cash : Inapplicable
September 16, 2025
Details:
Vestige Prime Absorvit (biotin) is a water-soluble B vitamin that plays a crucial role in various metabolic processes in the body. It is indicated for hair loss.
Lead Product(s): Biotin,Inapplicable
Therapeutic Area: Dermatology Brand Name: Vestige Prime Absorvit
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 09, 2024
Lead Product(s) : Biotin,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Vestige Marketing Launches Two Innovative Products
Details : Vestige Prime Absorvit (biotin) is a water-soluble B vitamin that plays a crucial role in various metabolic processes in the body. It is indicated for hair loss.
Product Name : Vestige Prime Absorvit
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 09, 2024
Details:
Biotin is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of Alopecia.
Lead Product(s): Biotin,Collagen,Keratin,Hyaluronic Acid
Therapeutic Area: Dermatology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 20, 2024
Lead Product(s) : Biotin,Collagen,Keratin,Hyaluronic Acid
Therapeutic Area : Dermatology
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Biotin is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of Alopecia.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 20, 2024
Details:
The two companies will establish a joint venture (JV Company) to introduce innovative nutraceutical brands to consumers, with Nestlé licensing brands like Nature's Bounty, an approved nutritional supplement.
Lead Product(s): Biotin,Keratin
Therapeutic Area: Nutrition and Weight Loss Brand Name: Nature’s Bounty
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Dr. Reddy\'s Laboratories
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement April 25, 2024
Lead Product(s) : Biotin,Keratin
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Dr. Reddy\'s Laboratories
Deal Size : Undisclosed
Deal Type : Agreement
Nestlé India and Dr. Reddy’s Form Joint Venture for Nutraceutical Portfolio
Details : The two companies will establish a joint venture (JV Company) to introduce innovative nutraceutical brands to consumers, with Nestlé licensing brands like Nature's Bounty, an approved nutritional supplement.
Product Name : Nature’s Bounty
Product Type : Miscellaneous
Upfront Cash : Undisclosed
April 25, 2024
Details:
Hydrolyzed Fish Collagen is a drug candidate, which is currently being evaluated in clinical studies for the treatment of Alopecia.
Lead Product(s):
Hydrolyzed Fish Collagen,Methylsulphonylmethane,Biotin,Pyridoxine Hydrochloride,Zinc,Ascorbic Acid,Niacin,Pantothenic Acid,Folic Acid,Pea Sprout Extract,Horsetail Aerial Parts Extract,Ashwagandha Root Extract,Saw Palmetto Fruit Extract,Nettle Leaves Extract,
Therapeutic Area: Dermatology
Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Undisclosed Sponsor:
Slovenian Research and Innovation Agency | Tosla d.o.o.
Deal Size: Inapplicable
Upfront Cash: Inapplicable
Deal Type: Inapplicable
December 18, 2023
Lead Product(s) :
Hydrolyzed Fish Collagen,Methylsulphonylmethane,Biotin,Pyridoxine Hydrochloride,Zinc,Ascorbic Acid,Niacin,Pantothenic Acid,Folic Acid,Pea Sprout Extract,Horsetail Aerial Parts Extract,Ashwagandha Root Extract,Saw Palmetto Fruit Extract,Nettle Leaves Extract,
Therapeutic Area :
Dermatology Highest Development Status :
Undisclosed Partner/Sponsor/Collaborator :
Slovenian Research and Innovation Agency | Tosla d.o.o. Deal Size : Inapplicable Deal Type : Inapplicable
The Effect of 24-week Dietary Intake of Food Supplements on Hair
Details : Hydrolyzed Fish Collagen is a drug candidate, which is currently being evaluated in clinical studies for the treatment of Alopecia.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
December 18, 2023
Details:
Biotin is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of Alopecia.
Lead Product(s): Biotin,Silicon
Therapeutic Area: Dermatology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Miscellaneous
Sponsor: ALS Beauty and Personal Care
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 25, 2023
Lead Product(s) : Biotin,Silicon
Therapeutic Area : Dermatology
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : ALS Beauty and Personal Care
Deal Size : Inapplicable
Deal Type : Inapplicable
Effectiveness of a Novel Dietary Ingredient on Hair Growth and Skin's Appearance
Details : Biotin is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of Alopecia.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 25, 2023
Details:
Biotin is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of Hypotrichosis.
Lead Product(s): Biotin,Inapplicable
Therapeutic Area: Rare Diseases and Disorders Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Miscellaneous
Sponsor: Orgenetics, Inc.
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 02, 2023
Lead Product(s) : Biotin,Inapplicable
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Orgenetics, Inc.
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Biotin is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of Hypotrichosis.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 02, 2023
Details:
Power Supplement is a Dietary Supplement drug candidate, which is currently being evaluated in clinical studies for the treatment of Alopecia.
Lead Product(s): Power Supplement,Biotin
Therapeutic Area: Dermatology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Dietary Supplement
Sponsor: Kosmoscience Ciência e Tecnologia Cosmética Ltda
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 14, 2023
Lead Product(s) : Power Supplement,Biotin
Therapeutic Area : Dermatology
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Kosmoscience Ciência e Tecnologia Cosmética Ltda
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Power Supplement is a Dietary Supplement drug candidate, which is currently being evaluated in clinical studies for the treatment of Alopecia.
Product Name : Undisclosed
Product Type : Dietary Supplement
Upfront Cash : Inapplicable
July 14, 2023
Details:
Choriogonadotropin Alpha is a Protein drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): Choriogonadotropin Alpha,Biotin
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Protein
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 11, 2022
Lead Product(s) : Choriogonadotropin Alpha,Biotin
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Can Biotin Supplementation be Used to Mask hCG Abuse?
Details : Choriogonadotropin Alpha is a Protein drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Protein
Upfront Cash : Inapplicable
July 11, 2022
Details:
Iron Bisglycinate Manganese Chloride is a drug candidate, which is currently being evaluated in clinical studies for the treatment of Inflammatory Diseases.
Lead Product(s): Iron Bisglycinate Manganese Chloride,Vitamin D,Guar Gum,Indole-3-carbinol,L-Methionine,Piceatannol,Biotin,Caffeine,Beta Carotene,Lutein Zinc Sulfate
Therapeutic Area: Immunology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Undisclosed
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 30, 2021
Lead Product(s) : Iron Bisglycinate Manganese Chloride,Vitamin D,Guar Gum,Indole-3-carbinol,L-Methionine,Piceatannol,Biotin,Caffeine,Beta Carotene,Lutein Zinc Sulfate
Therapeutic Area : Immunology
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
2021 PMT iAge® Intervention Trial by Edifice Health
Details : Iron Bisglycinate Manganese Chloride is a drug candidate, which is currently being evaluated in clinical studies for the treatment of Inflammatory Diseases.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
July 30, 2021
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
Regulatory Info : DISCN
Registration Country : USA
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E
Brand Name : M.V.C. 9+3
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 10MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;20 IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/ML;0.3MG/ML;330 UNITS/ML;1 IU/ML
Packaging :
Approval Date : 1985-08-08
Application Number : 18440
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E
Brand Name : MVC PLUS
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 10MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;20 IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/ML;0.3MG/ML;330 UNITS/ML;1 IU/ML
Packaging :
Approval Date : 1985-08-08
Application Number : 18439
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN E
Brand Name : BEROCCA PN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 50MG/ML;0.03MG/ML;0.0025MG/ML;7.5MG/ML;100 IU/ML;0.2MG/ML;20MG/ML;2MG/ML;1.8MG/ML;1.5MG/ML;1,650 IU/ML;5 IU/ML
Packaging :
Approval Date : 1985-10-10
Application Number : 6071
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E
Brand Name : M.V.I.-12 ADULT
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 10MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;20 IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/ML;0.3MG/ML;330 UNITS/ML;1 IU/ML
Packaging :
Approval Date : 1985-08-08
Application Number : 8809
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E
Brand Name : M.V.I.-12 ADULT
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 20MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;20 IU/ML;0.6MG/ML;4MG/ML;0.4MG/ML;0.36MG/ML;0.6MG/ML;330 UNITS/ML;1 IU/ML
Packaging :
Approval Date : 2004-04-22
Application Number : 8809
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E
Brand Name : M.V.I.-12 ADULT
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 20MG/ML;0.006MG/ML;0.05MCG/ML;1.5MG/ML;0.0005MG/ML;0.06MG/ML;4MG/ML;0.6MG/ML;0.36MG/ML;0.6MG/ML;0.1MG/ML;1MG/ML
Packaging :
Approval Date : 2004-09-09
Application Number : 8809
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E
Brand Name : M.V.I. PEDIATRIC
Dosage Form : FOR SOLUTION;INTRAVENOUS
Dosage Strength : 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
Packaging :
Approval Date : 2000-09-21
Application Number : 18920
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PANTOTHENIC ACID; PHYTONADIONE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A PALMITATE; VITAMIN E
Brand Name : VITAPED
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : N/A,80MG/VIAL;N/A,0.02MG/VIAL;N/A,0.001MG/VIAL;400 IU/10ML,N/A;N/A,0.14MG/VIAL;N/A,17MG/VIAL;N/A,5MG/VIAL;0.2MG/10ML,N/A;N/A,1MG/VIAL;N/A,1.4MG/VIAL;N/A,1.2MG/VIAL;EQ 2,300 UNITS BASE/10ML,N/A;7 IU/10
Packaging :
Approval Date : 1993-12-29
Application Number : 20176
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K
Brand Name : INFUVITE ADULT
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 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
Packaging :
Approval Date : 2000-05-18
Application Number : 21163
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K
Brand Name : INFUVITE ADULT
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 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
Packaging :
Approval Date : 2003-06-16
Application Number : 21163
Regulatory Info : RX
Registration Country : USA
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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
USFDA APPLICATION NUMBER - 18920
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
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
DOSAGE - INJECTABLE;INTRAVENOUS - 200MG/VIAL;...DOSAGE - INJECTABLE;INTRAVENOUS - 200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15MG/VIAL;0.005MG/VIAL;0.6MG/VIAL;40MG/VIAL;6MG/VIAL;3.6MG/VIAL;6MG/VIAL;1MG/VIAL;10MG/VIAL;0.15MG/VIAL
USFDA APPLICATION NUMBER - 21625
DOSAGE - INJECTABLE;INJECTION - 20MG/ML;0.006...DOSAGE - INJECTABLE;INJECTION - 20MG/ML;0.006MG/ML;0.05MCG/ML;1.5MG/ML;0.0005MG/ML;0.06MG/ML;4MG/ML;0.6MG/ML;0.36MG/ML;0.6MG/ML;0.1MG/ML;1MG/ML
USFDA APPLICATION NUMBER - 8809
Related Excipient Companies
EUROAPI
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Evonik
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharm-RX Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kewpie Corporation
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kirsch Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Aeon Procare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Alcedo Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ashland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Avesta Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Bioplus Life Sciences
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CD Formulation
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Clariant
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Corel Pharma Chem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Esteem Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Keval Exports
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kima Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lubrizol Life Science Health
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Bold Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nitika Pharmaceutical Specialities
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nomisma Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Welltone Material Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Silverline Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Symrise
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ulanqab Kema New Material
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Valens Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Vasa Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Zhejiang Huakang Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients by Applications
Fillers, Diluents & Binders
Thickeners and Stabilizers
Topical
Parenteral
Coating Systems & Additives
Solubilizers
Direct Compression
Disintegrants & Superdisintegrants
Taste Masking
Controlled & Modified Release
Granulation
Film Formers & Plasticizers
Lubricants & Glidants
Chewable & Orodispersible Aids
Emulsifying Agents
Co-Processed Excipients
Rheology Modifiers
Surfactant & Foaming Agents
API Stability Enhancers
Empty Capsules
Coloring Agents
Vegetarian Capsules
Soft Gelatin
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
13
PharmaCompass offers a list of Biotin 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 Biotin manufacturer or Biotin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Biotin manufacturer or Biotin supplier.
PharmaCompass also assists you with knowing the Biotin API Price utilized in the formulation of products. Biotin API Price is not always fixed or binding as the Biotin Price is obtained through a variety of data sources. The Biotin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Medebiotin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Medebiotin, including repackagers and relabelers. The FDA regulates Medebiotin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Medebiotin 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 Medebiotin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Medebiotin supplier is an individual or a company that provides Medebiotin active pharmaceutical ingredient (API) or Medebiotin finished formulations upon request. The Medebiotin suppliers may include Medebiotin API manufacturers, exporters, distributors and traders.
click here to find a list of Medebiotin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Medebiotin DMF (Drug Master File) is a document detailing the whole manufacturing process of Medebiotin active pharmaceutical ingredient (API) in detail. Different forms of Medebiotin DMFs exist exist since differing nations have different regulations, such as Medebiotin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Medebiotin DMF submitted to regulatory agencies in the US is known as a USDMF. Medebiotin USDMF includes data on Medebiotin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Medebiotin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Medebiotin suppliers with USDMF on PharmaCompass.
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 Medebiotin Drug Master File in Japan (Medebiotin JDMF) empowers Medebiotin 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 Medebiotin JDMF during the approval evaluation for pharmaceutical products. At the time of Medebiotin 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 Medebiotin suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Medebiotin Drug Master File in Korea (Medebiotin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Medebiotin. The MFDS reviews the Medebiotin KDMF as part of the drug registration process and uses the information provided in the Medebiotin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Medebiotin 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 Medebiotin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Medebiotin suppliers with KDMF on PharmaCompass.
A Medebiotin CEP of the European Pharmacopoeia monograph is often referred to as a Medebiotin Certificate of Suitability (COS). The purpose of a Medebiotin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Medebiotin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Medebiotin to their clients by showing that a Medebiotin CEP has been issued for it. The manufacturer submits a Medebiotin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Medebiotin CEP holder for the record. Additionally, the data presented in the Medebiotin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Medebiotin DMF.
A Medebiotin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Medebiotin 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 Medebiotin suppliers with CEP (COS) on PharmaCompass.
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 Medebiotin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Medebiotin API and other APIs are published in this directory by the FDA.
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 Medebiotin 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.
The NDC directory also contains data on finished compounded human drug products that contain Medebiotin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Medebiotin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Medebiotin suppliers with NDC on PharmaCompass.
Medebiotin 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 Medebiotin 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 Medebiotin GMP manufacturer or Medebiotin GMP API supplier for your needs.
A Medebiotin CoA (Certificate of Analysis) is a formal document that attests to Medebiotin's compliance with Medebiotin specifications and serves as a tool for batch-level quality control.
Medebiotin CoA mostly includes findings from lab analyses of a specific batch. For each Medebiotin 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.
Medebiotin may be tested according to a variety of international standards, such as European Pharmacopoeia (Medebiotin EP), Medebiotin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Medebiotin USP).
