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    Chemistry

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    Also known as: (-)-menthol, 2216-51-5, Levomenthol, L-(-)-menthol, Menthomenthol, Menthacamphor
    Molecular Formula
    C10H20O
    Molecular Weight
    156.26  g/mol
    InChI Key
    NOOLISFMXDJSKH-KXUCPTDWSA-N
    FDA UNII
    BZ1R15MTK7
    Levomenthol
    Levomenthol is a levo isomer of menthol, an organic compound made synthetically or obtained from peppermint or mint oils with flavoring and local anesthetic properties. When added to pharmaceuticals and foods, menthol functions as a fortifier for peppermint flavors. It also has a counterirritant effect on skin and mucous membranes, thereby producing a local analgesic or anesthetic effect.
    1 2D Structure

    Levomenthol

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (1R,2S,5R)-5-methyl-2-propan-2-ylcyclohexan-1-ol
    2.1.2 InChI
    InChI=1S/C10H20O/c1-7(2)9-5-4-8(3)6-10(9)11/h7-11H,4-6H2,1-3H3/t8-,9+,10-/m1/s1
    2.1.3 InChI Key
    NOOLISFMXDJSKH-KXUCPTDWSA-N
    2.1.4 Canonical SMILES
    CC1CCC(C(C1)O)C(C)C
    2.1.5 Isomeric SMILES
    C[C@@H]1CC[C@H]([C@@H](C1)O)C(C)C
    2.2 Other Identifiers
    2.2.1 UNII
    BZ1R15MTK7
    2.3 Synonyms
    2.3.1 Depositor-Supplied Synonyms

    1. (-)-menthol

    2. 2216-51-5

    3. Levomenthol

    4. L-(-)-menthol

    5. Menthomenthol

    6. Menthacamphor

    7. Peppermint Camphor

    8. (1r,2s,5r)-2-isopropyl-5-methylcyclohexanol

    9. U.s.p. Menthol

    10. Levomentholum

    11. Racementhol

    12. (1r,2s,5r)-(-)-menthol

    13. (-)-menthyl Alcohol

    14. (-)-(1r,3r,4s)-menthol

    15. Menthol Racemic

    16. Hexahydrothymol

    17. (1r)-(-)-menthol

    18. D,l-menthol

    19. (r)-(-)-menthol

    20. 89-78-1

    21. D-(-)-menthol

    22. Menthol, Dl-

    23. I-menthol

    24. Cyclohexanol, 5-methyl-2-(1-methylethyl)-, (1r,2s,5r)-

    25. P-menthan-3-ol

    26. (-)-trans-p-menthan-cis-ol

    27. Rac-menthol

    28. 1-menthol

    29. (l)-menthol

    30. Menthol(-)

    31. (1r,2s,5r)-5-methyl-2-(propan-2-yl)cyclohexan-1-ol

    32. Menthol, (1r,3r,4s)-(-)-

    33. (1r,3r,4s)-(-)-menthol

    34. Nci-c50000

    35. Cyclohexanol, 5-methyl-2-(1-methylethyl)-, (1r,2s,5r)-rel-

    36. 1r-menthol

    37. Nsc 62788

    38. Racemic Menthol

    39. Water-soluble Menthol

    40. (1r,2s,5r)-menthol

    41. 5-methyl-2-(1-methylethyl)cyclohexanol

    42. (1r,2s,5r)-2-isopropyl-5-methylcyclohexan-1-ol

    43. (1r,2s,5r)-rel-2-isopropyl-5-methylcyclohexanol

    44. Bz1r15mtk7

    45. (1r,2s,5r)-5-methyl-2-(1-methylethyl)cyclohexanol

    46. (1r-(1-alpha,2-beta,5-alpha))-5-methyl-2-(1-methylethyl)cyclohexanol

    47. (1r,2s,5r)-5-methyl-2-propan-2-ylcyclohexan-1-ol

    48. Menthol Crystals

    49. Chembl470670

    50. Ys08xha860

    51. Chebi:15409

    52. Menthol Natural

    53. Nsc2603

    54. (1r,2s,5r)-2-isopropyl-5-methyl-cyclohexanol

    55. (1r,2s,5s)-2-isopropyl-5-methyl-cyclohexanol

    56. Headache Crystals

    57. Nsc-2603

    58. Fema No. 2665

    59. Nsc-62788

    60. Menthol (van)

    61. Racementholum

    62. Thymomenthol

    63. Menthol, Cis-1,3,trans-1,4-

    64. Racementol

    65. L-menthol (natural)

    66. Nsc 2603

    67. (+-)-menthol

    68. Dsstox_cid_2180

    69. Menthol Racemique

    70. Levomenthol [inn:ban]

    71. Racementhol [inn:ban]

    72. Cyclohexanol, 5-methyl-2-(1-methylethyl)-, [1r-(1.alpha.,2.beta.,5.alpha.)]-

    73. Dsstox_rid_75798

    74. Dsstox_rid_76516

    75. Dsstox_gsid_20805

    76. Dsstox_gsid_22180

    77. Menthol Natural, Brazilian

    78. Menthol, L-

    79. Racementol [inn-spanish]

    80. Rel-(1r,2s,5r)-2-isopropyl-5-methylcyclohexanol

    81. Levomentholum [inn-latin]

    82. Menthol Racemique [french]

    83. Racementholum [inn-latin]

    84. Tra-kill Tracheal Mite Killer

    85. (1alpha,2beta,5alpha)-5-methyl-2(1-methylethyl)cyclohexanol

    86. Mfcd00062979

    87. Cas-89-78-1

    88. Ccris 375

    89. Cas-2216-51-5

    90. L-menthol (tn)

    91. Ccris 3728

    92. Ccris 4666

    93. Hsdb 5662

    94. Sr-05000001936

    95. (-)-p-menthan-3-ol

    96. Einecs 201-939-0

    97. Einecs 218-690-9

    98. Einecs 239-388-3

    99. Unii-bz1r15mtk7

    100. Brn 1902288

    101. Brn 3194263

    102. Levomentol

    103. Unii-ys08xha860

    104. (+-)-(1r*,3r*,4s*)-menthol

    105. Ss-bisabolol

    106. Ai3-52408

    107. Laevo-menthol

    108. Cyclohexanol, 5-methyl-2-(1-methylethyl)-, (1.alpha.,2.beta.,5.alpha.)-

    109. Cyclohexanol, 5-methyl-2-(1-methylethyl)-, (1r-(1alpha,2beta,5alpha))-

    110. Cyclohexanol, 5-methyl-2-(1-methylethyl)-, (1r-(1.alpha.,2.beta.,5.alpha.))-

    111. L-menthol Natural

    112. 1 -menthol

    113. Ncgc00159382-02

    114. Dextro,laevo-menthol

    115. Meggezone

    116. Menthol Crystals Usp

    117. L-mentholum

    118. L-menthol (jp17)

    119. Spectrum_000305

    120. Levomenthol [ii]

    121. Menthol [mi]

    122. 5-methyl-2-(1-methylethyl)cyclohexanol, (1alpha,2beta,5alpha)-

    123. L-menthol [jan]

    124. Menthol, (+/-)-

    125. Spectrum2_000855

    126. Spectrum3_001561

    127. Spectrum5_001060

    128. Levomenthol [inn]

    129. Racementhol [inn]

    130. M0545

    131. Dl-menthol [jan]

    132. Menthol [who-dd]

    133. Menthol,3,trans-1,4-

    134. Levomenthol [hsdb]

    135. Racementhol [hsdb]

    136. Ec 201-939-0

    137. Ec 218-690-9

    138. Schembl4613

    139. Bspbio_003062

    140. Kbioss_000785

    141. Levomenthol [who-dd]

    142. 2-06-00-00052 (beilstein Handbook Reference)

    143. 4-06-00-00151 (beilstein Handbook Reference)

    144. Mls002207256

    145. Divk1c_000820

    146. Menthol Racemate [mi]

    147. Spectrum1503134

    148. Menthol,3r,4s)-(-)-

    149. Spbio_000869

    150. Gtpl2430

    151. Npo-11

    152. Dtxsid1020805

    153. Dtxsid1022180

    154. (-)-menthol, Usp, 97%

    155. Hms502i22

    156. Kbio1_000820

    157. Kbio2_000785

    158. Kbio2_003353

    159. Kbio2_005921

    160. Kbio3_002562

    161. Noolisfmxdjskh-kxucptdwsa-

    162. (-)-menthol, Analytical Standard

    163. Ninds_000820

    164. Cyclohexanol, 5-methyl-2-(1-methylethyl)-, (1r,3r,4s)-

    165. Hms1922g13

    166. Hms2092l14

    167. Hms3885j18

    168. Levomenthol [ep Monograph]

    169. Pharmakon1600-01503134

    170. Cyclohexanol, 2-isopropyl-5-methyl

    171. Nsc62788

    172. Zinc1482164

    173. L-menthol, >=99%, Fcc, Fg

    174. Tox21_111620

    175. Tox21_201823

    176. Tox21_201919

    177. Tox21_202608

    178. Tox21_302999

    179. Tox21_303028

    180. Wln: L6tj Ay1&1 Bq D1

    181. Bdbm50318482

    182. Ccg-40300

    183. Cyclohexanol, 2-isopropyl-5-methyl-

    184. Cyclohexanol, 5-methyl-2-(1-methylethyl)-, (1alpha,2beta,5alpha)-

    185. Nsc758395

    186. S4714

    187. Akos016842647

    188. (1r, 2s, 5r-)-(-)-menthol

    189. Bs-3863

    190. Db00825

    191. Lmpr0102090001

    192. Nsc-758395

    193. Sdccgmls-0066659.p001

    194. (-)-trans-p-methan-cis-3-ol

    195. 1-iso Propyl-4-methyl Cyclohexan-2-ol

    196. Idi1_000820

    197. Wln: L6tj Ay1&1 Dq D1 -l

    198. Ncgc00164247-01

    199. Ncgc00164247-02

    200. Ncgc00164247-03

    201. Ncgc00256525-01

    202. Ncgc00256561-01

    203. Ncgc00259372-01

    204. Ncgc00259468-01

    205. Ncgc00260156-01

    206. D-(-)-phenylglycine Dane Potassium Salt

    207. Fema No. 2665, (-)-

    208. Smr001306785

    209. L-menthol, Natural, >=99%, Fcc, Fg

    210. Sbi-0051777.p002

    211. N1950

    212. S5868

    213. Fema No. 2665, (+/-)-

    214. Menthol (racemic) 100 Microg/ml In Methanol

    215. (+/-)-(1r*,3r*,4s*)-menthol

    216. (1r,2s,5r)-(-)-menthol, Synthetic Pellets

    217. C00400

    218. Cyclohexanol, (1.alpha.,2.beta.,5.alpha.)-

    219. D00064

    220. D70313

    221. (1r,2r,5s)-2-isopropyl-5-methyl-cyclohexanol

    222. Ab00052320_02

    223. L-menthol

    224. Levomenthol

    225. Menthomenthol

    226. Menthacamphor

    227. (1r,2s,5r)-(-)-menthol, >=99%, Sublimed

    228. A843308

    229. Q407418

    230. Q-201316

    231. Sr-05000001936-1

    232. Sr-05000001936-2

    233. (-)-menthol, Primary Pharmaceutical Reference Standard

    234. (1r,2s,5r)-(-)-menthol, Reagentplus(r), 99%

    235. 2-isopropyl-5-methylcyclohexanol-, (1r,2s,5r)- #

    236. Cyclohexanol, [1r-(1.alpha.,2.beta.,5.alpha.)]-

    237. (1r,2s,5r)-5-methyl-2-propan-2-yl-cyclohexan-1-ol

    238. Z1698549655

    239. (1r,2s,5r)-(-)-menthol, Vetec(tm) Reagent Grade, 98%

    240. 6c6a4a8c-a054-468c-a1f0-f29e39838cf2

    241. (1r, 2s, 5r)-5-methyl-2-(1-methylethyl)cyclohexyl Alcohol

    242. Menthol, United States Pharmacopeia (usp) Reference Standard

    243. (1r,2s,5r)-rel-5-methyl-2-(1-methylethyl)cyclohexanol

    244. L-menthol, Pharmaceutical Secondary Standard; Certified Reference Material

    245. (-)-menthol, Puriss., Meets Analytical Specification Of Ph. Eur., Bp, Usp, 98.0-102.0%

    246. (1r-(1-.alpha.,2-.beta.,5-.alpha.))-5-methyl-2-(1-methylethyl)cyclohexanol

    247. 114376-98-6

    2.4 Create Date
    2004-09-16
    3 Chemical and Physical Properties
    Molecular Weight 156.26 g/mol
    Molecular Formula C10H20O
    XLogP33
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count1
    Rotatable Bond Count1
    Exact Mass156.151415257 g/mol
    Monoisotopic Mass156.151415257 g/mol
    Topological Polar Surface Area20.2 Ų
    Heavy Atom Count11
    Formal Charge0
    Complexity120
    Isotope Atom Count0
    Defined Atom Stereocenter Count3
    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

    INHALERS CONTAINING MENTHOL COMPRESSED INTO BLOCKS OR CONES ARE COMMONLY USED FOR THE RELIEF OF NASAL CONGESTION, HEADACHE, AND NEURALGIA. IT IS NOW RARELY ADMINISTERED INTERNALLY. /MENTHOL/

    Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 722

    TOPICAL ANTIPRURITIC; MEDICATION (VET): HAS BEEN USED AS A MILD LOCAL ANESTHETIC, ANTISEPTIC & INTERNALLY AS A CARMINATIVE & GASTRIC SEDATIVE /MENTHOL/

    The Merck Index. 9th ed. Rahway, New Jersey: Merck & Co., Inc., 1976., p. 757

    IN LIQUEURS, CONFECTIONERY, PERFUMERY, CIGARETTES, COUGH DROPS, AND NASAL INHALERS /MENTHOL/

    The Merck Index. 9th ed. Rahway, New Jersey: Merck & Co., Inc., 1976., p. 757

    4.2 Drug Warning

    "COOLING" EFFECT OF L-MENTHOL WAS FOUND...TO BE SUPERIOR TO THAT PRODUCED BY OTHER ISOMERS; ODOR AND TASTE, TOO OF L-MENTHOL WERE SUPERIOR, WITH SOME OF THE ISOMERS PRODUCING SHARP, IRRITATING AND DISAGREEABLE PERCEPTIONS.

    Osol, A., and R. Pratt. (eds.). The United States Dispensatory. 27th ed. Philadelphia: J.B. Lippincott, 1973., p. 697

    4.3 Drug Indication

    Used to treat occasional minor irritation, pain, sore mouth, and sore throat as well as cough associated with a cold or inhaled irritants.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Menthol is a covalent organic compound made synthetically or obtained from peppermint or other mint oils. Menthol induces a cooling sensation on the skin upon inhalation, oral ingestion, or topical application by stimulating the cold-sensitive receptors expressed on the skin, without actually causing a drop in the skin temperature.

    5.2 Absorption, Distribution and Excretion

    ...THE PERCENTAGE OF A DOSE OF L-MENTHOL THAT IS EXCRETED COMBINED WITH GLUCURONIC ACID IN THE RABBIT DEPENDS ON THE MAGNITUDE OF THE DOSE; THE LARGER THE DOSE, THE LESS IS THE CONJUGATION.

    Opdyke, D.L.J. (ed.). Monographs on Fragrance Raw Materials. New York: Pergamon Press, 1979., p. 519

    5.3 Metabolism/Metabolites

    L-MENTHOL CONJUGATES READILY IN RABBIT FORMING L-MENTHYL-BETA-D-GLUCURONIDE. ABOUT HALF OF THE L-MENTHOL FED TO RABBITS IS EXCRETED COMBINED WITH GLUCURONIC ACID; THE FATE OF OTHER HALF IS NOT KNOWN, BUT IT IS POSSIBLE THAT RING FISSION OCCURS WITH CONSIDERABLE DEGRADATION OF THE MENTHOL MOLECULE.

    Opdyke, D.L.J. (ed.). Monographs on Fragrance Raw Materials. New York: Pergamon Press, 1979., p. 519

    IN DOGS, MUCH OXIDATION OF MENTHOL TAKES PLACE AND ONLY ABOUT 5% OF THE DOSE CAN BE RECOVERED IN URINE AS THE GLUCURONIDE. /MENTHOL/

    Opdyke, D.L.J. (ed.). Monographs on Fragrance Raw Materials. New York: Pergamon Press, 1979., p. 519

    L-MENTHOL WAS RAPIDLY BUT INCOMPLETELY GLUCURONIDATED. THE OUTPUT OF L-MENTHOL GLUCURONIDE WAS INCR IN ALL BUT 1 SUBJECT PRETREATED WITH CIMETIDINE (1 G/DAY FOR 1 WK), AN INHIBITOR OF OXIDATIVE DRUG METABOLISM, & IN ALL SUBJECTS PRETREATED WITH A DRUG-METABOLIZING ENZYME INDUCER, PHENOBARBITONE (60 MG NIGHTLY FOR 10 DAYS).

    BELL GD ET AL; BR J CLIN PHARMACOL 12 (2): 274 (1981)

    Corynebacterium sp. strain RWM1 grew with (-)-menthol, (-)-menthone and other acyclic monoterpenes as sole carbon sources. Growth on menthol was very slow, with a doubling time of more than 24 h, and was not rapid with (-)-menthone (doubling time 12 h). Concentrations of either carbon source greater than 0.025% inhibited growth. (-)-Menthone-grown cultures transiently accumulated 3,7-dimethyl-6-hydroxyoctanoate during growth, and (-)-menthol-grown cells oxidized (-)-menthol, (-)-menthone, 3,7-dimethyl-6-octanolide and 3,7-dimethyl-6-hydroxyoctanoate. Although neither a menthol oxidase nor a menthol dehydrogenase could be detected in extracts of (-)-menthol- or (-)-menthone-grown cells, an induced NADPH-linked monooxygenase with activity towards (-)-menthone was readily detected. With crude cell extracts, only 3,7-dimethyl-6-hydroxyoctanoate was detected as the reaction product. When the (-)-menthone monooxygenase was separated from an induced 3,7-dimethyl-6-octanolide hydrolase by chromatography on hydroxyapatite, the lactone 3,7-dimethyl-6-octanolide was shown to be the product of oxygenation.

    Williams DR, PW Trudgill; Microbiology (Reading) 140 (3): 611-6 (1994)

    (-)-Menthol has known human metabolites that include (2S,3S,4S,5R)-3,4,5-trihydroxy-6-[(1R,2S,5R)-5-methyl-2-propan-2-ylcyclohexyl]oxyoxane-2-carboxylic acid and p-Menthane-3,-8-diol.

    S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560

    5.4 Mechanism of Action

    Menthol primarily activates the cold-sensitive TRPM8 receptors in the skin. Menthol, after topical application, causes a feeling of coolness due to stimulation of 'cold' receptors by inhibiting Ca++ currents of neuronal membranes. It may also yield analgesic properties via kappa-opioid receptor agonism.

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    04

    Silverline Chemical

    India

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Silverline Chemical

    India

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

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    BIO Partnering at JPM
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 36666

    Submission : 2022-01-12

    Status : Active

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    05

    THE SUZUKI MENTHOL CO LTD

    Japan

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

    BIO Partnering at JPM
    Not Confirmed
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    THE SUZUKI MENTHOL CO LTD

    Japan

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

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    BIO Partnering at JPM
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 23408

    Submission : 2009-12-23

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    06

    NAGAOKA AND CO LTD

    Japan

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    NAGAOKA AND CO LTD

    Japan

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

    arrow
    BIO Partnering at JPM
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15452

    Submission : 2001-05-11

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 217MF10801

    Registrant's Address : Hyogo Prefecture Nishinomiya City Nishinomiyahama 4-7-18

    Initial Date of Registration : 2005-11-01

    Latest Date of Registration : --

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    07

    Takasago International

    Japan

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

    BIO Partnering at JPM
    Not Confirmed
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    Takasago International

    Japan

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

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    BIO Partnering at JPM
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 30689

    Submission : 2016-06-23

    Status : Active

    Type : IV

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 217MF11171

    Registrant's Address : 5-37-1 Kamata, Ota-ku, Tokyo

    Initial Date of Registration : 2005-12-12

    Latest Date of Registration : --

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    08

    Swati Menthol

    India

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Swati Menthol

    India

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

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    BIO Partnering at JPM
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35376

    Submission : 2021-01-05

    Status : Active

    Type : II

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    09

    Symrise

    Germany

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    Symrise

    Germany

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

    arrow
    BIO Partnering at JPM
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 22154

    Submission : 2008-11-03

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2004-100 - Rev 03

    Issue Date : 2020-04-21

    Type : Chemical

    Substance Number : 619

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 218MF10705

    Registrant's Address : Muehlenfeldstrasse 1 D-37 603 Holzminden Germany

    Initial Date of Registration : 2006-08-11

    Latest Date of Registration : --

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    10

    BASF

    Germany

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

    BIO Partnering at JPM
    Not Confirmed
    arrow

    BASF

    Germany

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

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    BIO Partnering at JPM
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2020-08-26

    Pay. Date : 2020-06-08

    DMF Number : 26711

    Submission : 2012-12-03

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2012-390 - Rev 01

    Issue Date : 2021-06-16

    Type : Chemical

    Substance Number : 619

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 48041-0001

    Start Marketing Date : 2014-07-01

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

     KDMF VMF Others AUDIT
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    Only 10 entries up to this point, click to access all click full view read-more
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    API Reference Price

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    [{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1659378600,"product":"LEVOMENTHOL CRYSTALS BP","address":"12A, BAKHTAWAR, 12th FLOOR, 229, NARIMAN POINT,","city":"MUMBAI","supplier":"JINDAL DRUGS","supplierCountry":"INDIA","foreign_port":"FELIXSTOWE","customer":"BELL, SONS & CO. (DRUGGISTS) LTD.","customerCountry":"UNITED KINGDOM","quantity":"2700.00","actualQuantity":"2700","unit":"KGS","unitRateFc":"25","totalValueFC":"62689.2","currency":"USD","unitRateINR":1847.4074074074074,"date":"02-Aug-2022","totalValueINR":"4988000","totalValueInUsd":"62689.2","indian_port":"JNPT","hs_no":"29061100","bill_no":"3237990","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"12A, BAKHTAWAR, 12th FLOOR, 229, NARIMAN POINT,, MUMBAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1662661800,"product":"LEVOMENTHOL BP\/EP","address":"2 K.M. STONE, MORADABAD ROAD,,","city":"SAMBAHAL,UTTAR PRADESH","supplier":"ARORA AROMATICS PVT LTD","supplierCountry":"INDIA","foreign_port":"TEL AVIV YAFO","customer":"REKAH PHARMACEUTICAL INDUSTRY","customerCountry":"ISRAEL","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"70","totalValueFC":"686.3","currency":"USD","unitRateINR":5500,"date":"09-Sep-2022","totalValueINR":"55000","totalValueInUsd":"686.3","indian_port":"DELHI AIR","hs_no":"29061100","bill_no":"4063381","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ISRAEL","selfForZScoreResived":"Pharma Grade","supplierPort":"DELHI AIR","supplierAddress":"2 K.M. STONE, MORADABAD ROAD,,, SAMBAHAL,UTTAR PRADESH","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1668105000,"product":"LEVOMENTHOL BP\/PERPPERMINT SAT.BOLD CRYS","address":"NEELAM CENTRE, B WING 4TH FLOOR HIND CYCLE ROAD, WORLI","city":"MUMBAI","supplier":"J.B.CHEMICALS & PHARMACEUTICALS","supplierCountry":"INDIA","foreign_port":"ALGIERS","customer":"BNP PARIBAS ELDJAZAIR","customerCountry":"ALGERIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"28","totalValueFC":"1409.1","currency":"USD","unitRateINR":2300,"date":"11-Nov-2022","totalValueINR":"115000","totalValueInUsd":"1409.1","indian_port":"BOMBAY AIR","hs_no":"29061100","bill_no":"5389248","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ALGERIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"NEELAM CENTRE, B WING 4TH FLOOR HIND CYCLE ROAD, WORLI, MUMBAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1676658600,"product":"MENTHOL (LEVOMENTHOL) BATCH NO.GR-02-100","address":"101 CIVIL LINES,NEAR BUDAUN CLUB","city":"BUDAUN,UTTAR PRADESH","supplier":"GRAMME PRODUCTS","supplierCountry":"INDIA","foreign_port":"TASHKENT","customer":"NIKA PHARM","customerCountry":"UZBEKISTAN","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"105","totalValueFC":"339","currency":"USD","unitRateINR":5600,"date":"18-Feb-2023","totalValueINR":"28000","totalValueInUsd":"339","indian_port":"DELHI AIR","hs_no":"29061100","bill_no":"7877991","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"UZBEKISTAN","selfForZScoreResived":"Pharma Grade","supplierPort":"DELHI AIR","supplierAddress":"101 CIVIL LINES,NEAR BUDAUN CLUB, BUDAUN,UTTAR PRADESH","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1682706600,"product":"MENTHOL(LEVOMENTHOL BP) BATCH NO H2-090\/","address":"PLOT NO-9, LSC,,GUJRANWALA TOWN-I","city":"DELHI,DELHI","supplier":"SHARP MINT LIMITED","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"TO","customerCountry":"BANGLADESH","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"35","totalValueFC":"1720.5","currency":"USD","unitRateINR":2820,"date":"29-Apr-2023","totalValueINR":"141000","totalValueInUsd":"1720.5","indian_port":"DELHI AIR","hs_no":"29061100","bill_no":"9648479","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"DELHI AIR","supplierAddress":"PLOT NO-9, LSC,,GUJRANWALA TOWN-I, DELHI,DELHI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1685989800,"product":"LEVOMENTHOL BP\/EP (BATCH NO.MLC-2305039","address":"2 K.M. STONE, MORADABAD ROAD,,","city":"SAMBAHAL,UTTAR PRADESH","supplier":"ARORA AROMATICS PVT LTD","supplierCountry":"INDIA","foreign_port":"VITEBSK","customer":"TO ORDER","customerCountry":"BELARUS","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"14.8","totalValueFC":"7810.6","currency":"EUR","unitRateINR":1284.000354,"date":"06-Jun-2023","totalValueINR":"642000.177","totalValueInUsd":"7810.6","indian_port":"JNPT","hs_no":"29061100","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"BELARUS","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"2 K.M. STONE, MORADABAD ROAD,,, SAMBAHAL,UTTAR PRADESH","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1703874600,"product":"LEVOMENTHOL BP\/PERPPERMINT SAT.BOLD CRYSTALS","address":"NEELAM CENTRE, B WING, 4TH FLOOR,","city":"MUMBAI, MAHARASHTRA.","supplier":"J.B.CHEMICALS & PHARMACEUTICALS","supplierCountry":"INDIA","foreign_port":"ALGIERS","customer":"BIOPHARM SPA","customerCountry":"ALGERIA","quantity":"199.87","actualQuantity":"199.865","unit":"KGS","unitRateFc":"33.5","totalValueFC":"5550","currency":"USD","unitRateINR":2311.5603032046629,"date":"30-Dec-2023","totalValueINR":"462000","totalValueInUsd":"5550","indian_port":"Bombay Air","hs_no":"29061100","bill_no":"6436610","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ALGERIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"NEELAM CENTRE, B WING, 4TH FLOOR,, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1703874600,"product":"LEVOMENTHOL BP\/PERPPERMINT SAT.BOLD CRYSTALS","address":"NEELAM CENTRE, B WING, 4TH FLOOR,","city":"MUMBAI, MAHARASHTRA.","supplier":"J.B.CHEMICALS & PHARMACEUTICALS","supplierCountry":"INDIA","foreign_port":"ALGIERS","customer":"BIOPHARM SPA","customerCountry":"ALGERIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"33.5","totalValueFC":"5550","currency":"USD","unitRateINR":2310,"date":"30-Dec-2023","totalValueINR":"462000","totalValueInUsd":"5550","indian_port":"Bombay Air","hs_no":"29061100","bill_no":"6436610","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ALGERIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"NEELAM CENTRE, B WING, 4TH FLOOR,, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1709058600,"product":"MENTHOL CRYSTALS (LEVOMENTHOL) BP. BATCHNO. MLC-2402017 MFG DATE:- 13\/02\/2024 EXPIRY DATE:- 12\/02\/2029","address":"2 K.M. STONE, MORADABAD ROAD,","city":"DISTT. MORADABAD.","supplier":"ARORA AROMATICS PVT LTD","supplierCountry":"INDIA","foreign_port":"JEDDAH","customer":"TO","customerCountry":"SAUDI ARABIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"17.8","totalValueFC":"3244.5","currency":"USD","unitRateINR":1346.05,"date":"28-Feb-2024","totalValueINR":"269210","totalValueInUsd":"3244.5","indian_port":"Delhi Air","hs_no":"29061100","bill_no":"7917932","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"SAUDI ARABIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Delhi Air","supplierAddress":"2 K.M. STONE, MORADABAD ROAD,, DISTT. MORADABAD.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1716921000,"product":"MENTHOL (LEVOMENTHOL) B.NO. MLC-2405051","address":"2 K.M. STONE, MORADABAD ROAD,","city":"DISTT. MORADABAD.","supplier":"ARORA AROMATICS PVT LTD","supplierCountry":"INDIA","foreign_port":"GDYNIA","customer":"TO ORDER","customerCountry":"POLAND","quantity":"5000.00","actualQuantity":"5000","unit":"KGS","unitRateFc":"14.7","totalValueFC":"72879.1","currency":"USD","unitRateINR":1214.9549999999999,"date":"29-May-2024","totalValueINR":"6074775","totalValueInUsd":"72879.1","indian_port":"JNPT","hs_no":"29061100","bill_no":"1267234","productDescription":"API","marketType":"REGULATED MARKET","country":"POLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"2 K.M. STONE, MORADABAD ROAD,, DISTT. MORADABAD.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721586600,"product":"MENTHOL (LEVOMENTHOL BP) (BATCH NO.H2-017\/L\/24-25 M.11-05-2024 E.10-05-2029)","address":"PLOT NO-9, LSC,","city":"DELHI.","supplier":"SHARP MINT LIMITED","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"TO ORDER","customerCountry":"BANGLADESH","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"35","totalValueFC":"1721.6","currency":"USD","unitRateINR":2878.2399999999998,"date":"22-Jul-2024","totalValueINR":"143912","totalValueInUsd":"1721.6","indian_port":"Delhi Air","hs_no":"29061100","bill_no":"2605304","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Delhi Air","supplierAddress":"PLOT NO-9, LSC,, DELHI.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722364200,"product":"LEVOMENTHOL BP. B.NO. MLC-2405051 BATCHNO. MLC-2405051 MFG DATE. 21\/05\/2024 EXPIRY DATE. 20\/05\/2029","address":"2 K.M. STONE, MORADABAD ROAD,","city":"DISTT. MORADABAD.","supplier":"ARORA AROMATICS PVT LTD","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"TO THE ORDER OF","customerCountry":"BANGLADESH","quantity":"75.00","actualQuantity":"75","unit":"KGS","unitRateFc":"25","totalValueFC":"1698.1","currency":"USD","unitRateINR":1892.6666666666667,"date":"31-Jul-2024","totalValueINR":"141950","totalValueInUsd":"1698.1","indian_port":"Delhi Air","hs_no":"29061100","bill_no":"2845431","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Delhi Air","supplierAddress":"2 K.M. STONE, MORADABAD ROAD,, DISTT. MORADABAD.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722364200,"product":"LEVOMENTHOL BP. B.NO. MLC-2405051 BATCHNO. MLC-2405051 MFG DATE. 21\/05\/2024 EXPIRY DATE. 20\/05\/2029","address":"2 K.M. STONE, MORADABAD ROAD,","city":"DISTT. MORADABAD.","supplier":"ARORA AROMATICS PVT LTD","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"TO THE ORDER OF","customerCountry":"BANGLADESH","quantity":"75.00","actualQuantity":"75","unit":"KGS","unitRateFc":"25","totalValueFC":"1845.3","currency":"USD","unitRateINR":2056.6666666666665,"date":"31-Jul-2024","totalValueINR":"154250","totalValueInUsd":"1845.3","indian_port":"Delhi Air","hs_no":"29061100","bill_no":"2844045","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Delhi Air","supplierAddress":"2 K.M. STONE, MORADABAD ROAD,, DISTT. MORADABAD.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729449000,"product":"MENTHOL (LEVOMENTHOL BP LARGE CRYSTAL) (120 X 25 KG. NETT) AE-6227 PRODUCT CODE:1MOL9200SA BATCH NO.: AE\/MC\/030\/23-24","address":"B6-9 ROSHAN BAGH INDUSTRIAL ESTATE","city":"N\/A","supplier":"AGGARWWAL EXPORTS","supplierCountry":"INDIA","foreign_port":"MARSEILLE","customer":"TO ORDER","customerCountry":"FRANCE","quantity":"3000.00","actualQuantity":"3000","unit":"KGS","unitRateFc":"14.8","totalValueFC":"42281","currency":"USD","unitRateINR":1184.2410666666667,"date":"21-Oct-2024","totalValueINR":"3552723.2","totalValueInUsd":"42281","indian_port":"JNPT","hs_no":"29061110","bill_no":"4991137","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"B6-9 ROSHAN BAGH INDUSTRIAL ESTATE, N\/A","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730917800,"product":"LEVOMENTHOL B.NO. MLC-2410103 MFG DT. 11\/10\/2024 EXPIRY DT.10\/10\/2029","address":"2 K.M. STONE, MORADABAD ROAD,","city":"DISTT. MORADABAD.","supplier":"ARORA AROMATICS PVT LTD","supplierCountry":"INDIA","foreign_port":"GDYNIA","customer":"TO ORDER","customerCountry":"POLAND","quantity":"5000.00","actualQuantity":"5000","unit":"KGS","unitRateFc":"14.7","totalValueFC":"72465.1","currency":"USD","unitRateINR":1223.04,"date":"07-Nov-2024","totalValueINR":"6115200","totalValueInUsd":"72465.1","indian_port":"JNPT","hs_no":"29061110","bill_no":"5428462","productDescription":"API","marketType":"REGULATED MARKET","country":"POLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"2 K.M. STONE, MORADABAD ROAD,, DISTT. MORADABAD.","customerAddress":""}]
    02-Aug-2022
    07-Nov-2024
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    ABOUT THIS PAGE

    CAS-2216-51-5 Manufacturers

    A CAS-2216-51-5 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CAS-2216-51-5, including repackagers and relabelers. The FDA regulates CAS-2216-51-5 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CAS-2216-51-5 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 CAS-2216-51-5 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    CAS-2216-51-5 Suppliers

    A CAS-2216-51-5 supplier is an individual or a company that provides CAS-2216-51-5 active pharmaceutical ingredient (API) or CAS-2216-51-5 finished formulations upon request. The CAS-2216-51-5 suppliers may include CAS-2216-51-5 API manufacturers, exporters, distributors and traders.

    click here to find a list of CAS-2216-51-5 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    CAS-2216-51-5 USDMF

    A CAS-2216-51-5 DMF (Drug Master File) is a document detailing the whole manufacturing process of CAS-2216-51-5 active pharmaceutical ingredient (API) in detail. Different forms of CAS-2216-51-5 DMFs exist exist since differing nations have different regulations, such as CAS-2216-51-5 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A CAS-2216-51-5 DMF submitted to regulatory agencies in the US is known as a USDMF. CAS-2216-51-5 USDMF includes data on CAS-2216-51-5's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CAS-2216-51-5 USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of CAS-2216-51-5 suppliers with USDMF on PharmaCompass.

    CAS-2216-51-5 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 CAS-2216-51-5 Drug Master File in Japan (CAS-2216-51-5 JDMF) empowers CAS-2216-51-5 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 CAS-2216-51-5 JDMF during the approval evaluation for pharmaceutical products. At the time of CAS-2216-51-5 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 CAS-2216-51-5 suppliers with JDMF on PharmaCompass.

    CAS-2216-51-5 CEP

    A CAS-2216-51-5 CEP of the European Pharmacopoeia monograph is often referred to as a CAS-2216-51-5 Certificate of Suitability (COS). The purpose of a CAS-2216-51-5 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of CAS-2216-51-5 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of CAS-2216-51-5 to their clients by showing that a CAS-2216-51-5 CEP has been issued for it. The manufacturer submits a CAS-2216-51-5 CEP (COS) as part of the market authorization procedure, and it takes on the role of a CAS-2216-51-5 CEP holder for the record. Additionally, the data presented in the CAS-2216-51-5 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the CAS-2216-51-5 DMF.

    A CAS-2216-51-5 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. CAS-2216-51-5 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 CAS-2216-51-5 suppliers with CEP (COS) on PharmaCompass.

    CAS-2216-51-5 WC

    A CAS-2216-51-5 written confirmation (CAS-2216-51-5 WC) is an official document issued by a regulatory agency to a CAS-2216-51-5 manufacturer, verifying that the manufacturing facility of a CAS-2216-51-5 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting CAS-2216-51-5 APIs or CAS-2216-51-5 finished pharmaceutical products to another nation, regulatory agencies frequently require a CAS-2216-51-5 WC (written confirmation) as part of the regulatory process.

    click here to find a list of CAS-2216-51-5 suppliers with Written Confirmation (WC) on PharmaCompass.

    CAS-2216-51-5 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 CAS-2216-51-5 as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for CAS-2216-51-5 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 CAS-2216-51-5 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 CAS-2216-51-5 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a CAS-2216-51-5 NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of CAS-2216-51-5 suppliers with NDC on PharmaCompass.

    CAS-2216-51-5 GMP

    CAS-2216-51-5 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 CAS-2216-51-5 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 CAS-2216-51-5 GMP manufacturer or CAS-2216-51-5 GMP API supplier for your needs.

    CAS-2216-51-5 CoA

    A CAS-2216-51-5 CoA (Certificate of Analysis) is a formal document that attests to CAS-2216-51-5's compliance with CAS-2216-51-5 specifications and serves as a tool for batch-level quality control.

    CAS-2216-51-5 CoA mostly includes findings from lab analyses of a specific batch. For each CAS-2216-51-5 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.

    CAS-2216-51-5 may be tested according to a variety of international standards, such as European Pharmacopoeia (CAS-2216-51-5 EP), CAS-2216-51-5 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (CAS-2216-51-5 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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