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    Chemistry

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    Also known as: 66085-59-4, Nimotop, Periplum, Admon, Nimodipino, Nymalize
    Molecular Formula
    C21H26N2O7
    Molecular Weight
    418.4  g/mol
    InChI Key
    UIAGMCDKSXEBJQ-UHFFFAOYSA-N
    FDA UNII
    57WA9QZ5WH
    Nimodipine
    A calcium channel blockader with preferential cerebrovascular activity. It has marked cerebrovascular dilating effects and lowers blood pressure.
    Nimodipine is a Dihydropyridine Calcium Channel Blocker. The mechanism of action of nimodipine is as a Calcium Channel Antagonist.
    1 2D Structure

    Nimodipine

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    3-O-(2-methoxyethyl) 5-O-propan-2-yl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
    2.1.2 InChI
    InChI=1S/C21H26N2O7/c1-12(2)30-21(25)18-14(4)22-13(3)17(20(24)29-10-9-28-5)19(18)15-7-6-8-16(11-15)23(26)27/h6-8,11-12,19,22H,9-10H2,1-5H3
    2.1.3 InChI Key
    UIAGMCDKSXEBJQ-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC1=C(C(C(=C(N1)C)C(=O)OC(C)C)C2=CC(=CC=C2)[N+](=O)[O-])C(=O)OCCOC
    2.2 Other Identifiers
    2.2.1 UNII
    57WA9QZ5WH
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Admon

    2. Bay E 9736

    3. Bayvit, Nimodipino

    4. Brainal

    5. Calnit

    6. E 9736, Bay

    7. Hexal, Nimodipin

    8. Kenesil

    9. Modus

    10. Nimodipin Hexal

    11. Nimodipin Isis

    12. Nimodipin-isis

    13. Nimodipino Bayvit

    14. Nimotop

    15. Nymalize

    16. Remontal

    2.3.2 Depositor-Supplied Synonyms

    1. 66085-59-4

    2. Nimotop

    3. Periplum

    4. Admon

    5. Nimodipino

    6. Nymalize

    7. Bay E 9736

    8. Nimodipinum

    9. Bay-e 9736

    10. Nimodipinum [inn-latin]

    11. Nimodipino [inn-spanish]

    12. Bay-e-9736

    13. Nemotan

    14. 3-isopropyl 5-(2-methoxyethyl) 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate

    15. Isopropyl 2-methoxyethyl 1,4-dihydro-2,6-dimethyl-4-(m-nitrophenyl)-3,5-pyridinedicarboxylate

    16. Nimodipine Ap

    17. Chebi:7575

    18. Nimodipine (nimotop)

    19. 3,5-pyridinedicarboxylic Acid, 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-, 2-methoxyethyl 1-methylethyl Ester

    20. Nsc-758476

    21. 57wa9qz5wh

    22. Mls000863294

    23. 3-o-(2-methoxyethyl) 5-o-propan-2-yl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate

    24. 3-(2-methoxyethyl) 5-propan-2-yl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate

    25. Ncgc00015714-09

    26. Smr000058300

    27. Dsstox_cid_3370

    28. Dsstox_rid_76998

    29. Isopropyl 2-methoxyethyl 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylate

    30. Dsstox_gsid_23370

    31. 2-methoxyethyl Propan-2-yl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate

    32. Nimogel

    33. Drg-0139

    34. Nimotop(tm)

    35. 1-methylethyl 2-(methyloxy)ethyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate

    36. 2,6-dimethyl-4-(3'-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylic Acid 3-beta-methoxyethyl Ester 5-isopropyl Ester

    37. Sr-01000075335

    38. Nimotop (tn)

    39. Einecs 266-127-0

    40. Unii-57wa9qz5wh

    41. Brn 0459792

    42. Nimovent

    43. Nimodipime,(s)

    44. Nimodipine [usan:usp:inn:ban]

    45. Nymalize (tn)

    46. Cas-66085-59-4

    47. Mfcd00153848

    48. Eg-1961

    49. Opera_id_14

    50. Spectrum_001880

    51. Nimodipine [mi]

    52. Specplus_000716

    53. Nimodipine (usp/inn)

    54. Nimodipine [inn]

    55. Nimodipine [jan]

    56. Prestwick0_000918

    57. Prestwick1_000918

    58. Prestwick2_000918

    59. Prestwick3_000918

    60. Spectrum2_001562

    61. Spectrum3_000766

    62. Spectrum4_000791

    63. Spectrum5_001687

    64. Nimodipine [usan]

    65. N-149

    66. Nimodipine [vandf]

    67. Nimodipine [mart.]

    68. Nimodipine [usp-rs]

    69. Nimodipine [who-dd]

    70. (+/-)-nimodipine

    71. Cbiol_001832

    72. Lopac0_000891

    73. Schembl34041

    74. Bspbio_000796

    75. Bspbio_001397

    76. Bspbio_002412

    77. Kbiogr_000117

    78. Kbiogr_001262

    79. Kbioss_000117

    80. Kbioss_002408

    81. Mls000069381

    82. Mls001076550

    83. Mls001424155

    84. Mls002154061

    85. Mls002172461

    86. Mls003899190

    87. Divk1c_006812

    88. Spectrum1503600

    89. Spbio_001464

    90. Spbio_002985

    91. Bpbio1_000876

    92. Gtpl2523

    93. Chembl3197349

    94. Dtxsid5023370

    95. Nimodipine [orange Book]

    96. Schembl22882841

    97. Kbio1_001756

    98. Kbio2_000117

    99. Kbio2_002403

    100. Kbio2_002685

    101. Kbio2_004971

    102. Kbio2_005253

    103. Kbio2_007539

    104. Kbio3_000233

    105. Kbio3_000234

    106. Kbio3_001632

    107. 3-isopropyl 5-(2-methoxyethyl)

    108. Brd8407

    109. Nimodipine [ep Monograph]

    110. Nimodipine [usp Impurity]

    111. Bio1_000118

    112. Bio1_000607

    113. Bio1_001096

    114. Bio2_000117

    115. Bio2_000597

    116. Hms1361f19

    117. Hms1570h18

    118. Hms1791f19

    119. Hms1922e04

    120. Hms1989f19

    121. Hms2052m05

    122. Hms2089h13

    123. Hms2093g11

    124. Hms2097h18

    125. Hms2234b05

    126. Hms3262d04

    127. Hms3266o22

    128. Hms3369g07

    129. Hms3394m05

    130. Hms3402f19

    131. Hms3411i12

    132. Hms3657i03

    133. Hms3675i12

    134. Hms3714h18

    135. Nimodipine [usp Monograph]

    136. Pharmakon1600-01503600

    137. 3,5-pyridinecarboxylic Acid 2-methoxyethyl 1-methylethyl Ester

    138. Act02628

    139. Albb-015317

    140. Amy40399

    141. Bcp21152

    142. Brd-8407

    143. Hy-b0265

    144. 2,6-dimethyl-4-(3-nitrophenyl)-

    145. Tox21_110202

    146. Tox21_500891

    147. Bbl028286

    148. Bdbm50101971

    149. Ca-211

    150. Ccg-39340

    151. Nsc758476

    152. S1747

    153. Stk642934

    154. Akos005174934

    155. Akos015852459

    156. Nimodipine - Cas 66085-59-4

    157. Nimodipine 100 Microg/ml In Methanol

    158. Tox21_110202_1

    159. Ac-8484

    160. Ccg-101085

    161. Db00393

    162. Ks-1304

    163. Lp00891

    164. Nc00335

    165. Nsc 758476

    166. Sdccgsbi-0050866.p004

    167. Idi1_033867

    168. Isopropyl 2-methoxyethyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate

    169. Ncgc00015714-04

    170. Ncgc00015714-05

    171. Ncgc00015714-06

    172. Ncgc00015714-07

    173. Ncgc00015714-08

    174. Ncgc00015714-10

    175. Ncgc00015714-11

    176. Ncgc00015714-12

    177. Ncgc00015714-13

    178. Ncgc00015714-16

    179. Ncgc00015714-28

    180. Ncgc00021456-02

    181. Ncgc00024675-02

    182. Ncgc00024675-03

    183. Ncgc00024675-04

    184. Ncgc00024675-05

    185. Ncgc00024675-06

    186. Ncgc00024675-07

    187. Ncgc00024675-08

    188. Ncgc00024675-09

    189. Ncgc00261576-01

    190. Nimodipine 100 Microg/ml In Acetonitrile

    191. O5-isopropyl O3-(2-methoxyethyl) 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate

    192. Smr002530605

    193. Sbi-0050866.p003

    194. Ab00513963

    195. Eu-0100891

    196. Ft-0602600

    197. N0896

    198. Sw219238-1

    199. C07267

    200. D00438

    201. F20554

    202. 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-

    203. Ab00053314-03

    204. Ab00053314-04

    205. Ab00053314_05

    206. Ab00053314_06

    207. 085n594

    208. Q421429

    209. Sr-01000075335-1

    210. Sr-01000075335-2

    211. Sr-01000075335-4

    212. Sr-01000075335-5

    213. Sr-01000075335-7

    214. Brd-a58048407-001-06-3

    215. Brd-a58048407-001-09-7

    216. Bay E 9736 Pound>> Bay-e-9736 Pound>> Baye97

    217. Nimodipine, British Pharmacopoeia (bp) Reference Standard

    218. Nimodipine, European Pharmacopoeia (ep) Reference Standard

    219. Nimodipine, United States Pharmacopeia (usp) Reference Standard

    220. Nimodipine, Pharmaceutical Secondary Standard; Certified Reference Material

    221. Nimodipine For Peak Identification, Europepharmacopoeia (ep) Reference Standard

    222. 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic Acid 2-methyloxyethyl 1-methylethyl Ester

    223. 2-methoxyethyl 1-methylethyl 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylate

    224. 3,5-pyridinedicarboxylic Acid, 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-, 3-(2-methoxyethyl) 5-(1-methylethyl) Ester

    225. 3,5-pyridinedicarboxylic Acid, 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-,?2-methoxyethyl 1-methylethyl Ester

    226. 3-isopropyl 5-(2-methoxyethyl) 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydro-3,5-pyridinedicarboxylate #

    227. 3-isopropyl5-(2-methoxyethyl)2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate

    228. Isopropyl 2-methoxyethyl 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylate

    229. O5-(2-methoxyethyl) O3-propan-2-yl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate

    2.4 Create Date
    2005-03-25
    3 Chemical and Physical Properties
    Molecular Weight 418.4 g/mol
    Molecular Formula C21H26N2O7
    XLogP33.1
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count9
    Exact Mass418.17400117 g/mol
    Monoisotopic Mass418.17400117 g/mol
    Topological Polar Surface Area120 Ų
    Heavy Atom Count30
    Formal Charge0
    Complexity736
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count1
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameNimodipine
    PubMed HealthNimodipine (By mouth)
    Drug ClassesCardiovascular Agent
    Drug LabelNimodipine belongs to the class of pharmacological agents known as calcium channel blockers. Nimodipine is isopropyl 2 - methoxyethyl 1, 4 - dihydro - 2, 6 - dimethyl - 4 - (m-nitrophenyl) - 3, 5 pyridinedicarboxylate.It has a molecular weight...
    Active IngredientNimodipine
    Dosage FormCapsule
    RouteOral
    Strength30mg
    Market StatusPrescription
    CompanyThepharmanetwork; Sun Pharm Inds; Barr Labs; Banner Pharmacaps

    2 of 4  
    Drug NameNymalize
    PubMed HealthNimodipine (By mouth)
    Drug ClassesCardiovascular Agent
    Drug LabelNYMALIZE contains nimodipine, a dihydropyridine calcium channel blocker. Nimodipine is isopropyl 2-methoxyethyl 1,4-dihydro-2,6-dimethyl-4-(m-nitrophenyl)-3,5-pyridinedicarboxylate. It has a molecular weight of 418.5 and a molecular formula of C21H26...
    Active IngredientNimodipine
    Dosage FormSolution
    RouteOral
    Strength60mg/20ml
    Market StatusPrescription
    CompanyArbor Pharms

    3 of 4  
    Drug NameNimodipine
    PubMed HealthNimodipine (By mouth)
    Drug ClassesCardiovascular Agent
    Drug LabelNimodipine belongs to the class of pharmacological agents known as calcium channel blockers. Nimodipine is isopropyl 2 - methoxyethyl 1, 4 - dihydro - 2, 6 - dimethyl - 4 - (m-nitrophenyl) - 3, 5 pyridinedicarboxylate.It has a molecular weight...
    Active IngredientNimodipine
    Dosage FormCapsule
    RouteOral
    Strength30mg
    Market StatusPrescription
    CompanyThepharmanetwork; Sun Pharm Inds; Barr Labs; Banner Pharmacaps

    4 of 4  
    Drug NameNymalize
    PubMed HealthNimodipine (By mouth)
    Drug ClassesCardiovascular Agent
    Drug LabelNYMALIZE contains nimodipine, a dihydropyridine calcium channel blocker. Nimodipine is isopropyl 2-methoxyethyl 1,4-dihydro-2,6-dimethyl-4-(m-nitrophenyl)-3,5-pyridinedicarboxylate. It has a molecular weight of 418.5 and a molecular formula of C21H26...
    Active IngredientNimodipine
    Dosage FormSolution
    RouteOral
    Strength60mg/20ml
    Market StatusPrescription
    CompanyArbor Pharms

    4.2 Drug Indication

    For use as an adjunct to improve neurologic outcome following subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms by reducing the incidence and severity of ischemic deficits.

    FDA Label

    Treatment of aneurysmal subarchnoidal haemorrhage

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Nimodipine belongs to the class of pharmacological agents known as calcium channel blockers. Nimodipine is indicated for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in patients with subarachnoid hemorrhage from ruptured congenital aneurysms who are in good neurological condition post-ictus (e.g., Hunt and Hess Grades I-III). The contractile processes of smooth muscle cells are dependent upon calcium ions, which enter these cells during depolarization as slow ionic transmembrane currents. Nimodipine inhibits calcium ion transfer into these cells and thus inhibits contractions of vascular smooth muscle. In animal experiments, nimodipine had a greater effect on cerebral arteries than on arteries elsewhere in the body perhaps because it is highly lipophilic, allowing it to cross the blood brain barrier.

    5.2 MeSH Pharmacological Classification

    Antihypertensive Agents

    Drugs used in the treatment of acute or chronic vascular HYPERTENSION regardless of pharmacological mechanism. Among the antihypertensive agents are DIURETICS; (especially DIURETICS, THIAZIDE); ADRENERGIC BETA-ANTAGONISTS; ADRENERGIC ALPHA-ANTAGONISTS; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; CALCIUM CHANNEL BLOCKERS; GANGLIONIC BLOCKERS; and VASODILATOR AGENTS. (See all compounds classified as Antihypertensive Agents.)

    Calcium Channel Blockers

    A class of drugs that act by selective inhibition of calcium influx through cellular membranes. (See all compounds classified as Calcium Channel Blockers.)

    Vasodilator Agents

    Drugs used to cause dilation of the blood vessels. (See all compounds classified as Vasodilator Agents.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    NIMODIPINE
    5.3.2 FDA UNII
    57WA9QZ5WH
    5.3.3 Pharmacological Classes
    Dihydropyridine Calcium Channel Blocker [EPC]; Dihydropyridines [CS]; Calcium Channel Antagonists [MoA]
    5.4 ATC Code

    C08CA06

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

    C - Cardiovascular system

    C08 - Calcium channel blockers

    C08C - Selective calcium channel blockers with mainly vascular effects

    C08CA - Dihydropyridine derivatives

    C08CA06 - Nimodipine

    5.5 Absorption, Distribution and Excretion

    Absorption

    In humans, nimodipine is rapidly absorbed after oral administration, and peak concentrations are generally attained within one hour. Bioavailability is 100% following intravenous administration and 3-30% following oral administration due to extensive first-pass metabolism.

    Route of Elimination

    Nimodipine is eliminated almost exclusively in the form of metabolites and less than 1% is recovered in the urine as unchanged drug. Numerous metabolites, all of which are either inactive or considerably less active than the parent compound, have been identified.

    5.6 Metabolism/Metabolites

    Hepatic metabolism via CYP 3A4.

    Nimodipine has known human metabolites that include 2,6-Dimethyl-4-(3-nitrophenyl)-5-propan-2-yloxycarbonyl-1,4-dihydropyridine-3-carboxylic acid, Dehydro nimodipine, and Unii-96S4GG1upr.

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

    5.7 Biological Half-Life

    1.7-9 hours

    5.8 Mechanism of Action

    Although the precise mechanism of action is not known, nimodipine blocks intracellular influx of calcium through voltage-dependent and receptor-operated slow calcium channels across the membranes of myocardial, vascular smooth muscle, and neuronal cells. By specifically binding to L-type voltage-gated calcium channels, nimodipine inhibits the calcium ion transfer, resulting in the inhibition of vascular smooth muscle contraction. Evidence suggests that the dilation of small cerebral resistance vessels, with a resultant increase in collateral circulation, and/or a direct effect involving the prevention of calcium overload in neurons may be responsible for nimodipine's clinical effect in patients with subarachnoid hemorrhage.

    API Reference Price

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    08-Feb-2021
    08-Sep-2024
    KGS
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    DOSAGE - SOLUTION;ORAL - 3MG/ML **Federal Reg...DOSAGE - SOLUTION;ORAL - 3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 203340

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    DOSAGE - SOLUTION;ORAL - 6MG/ML

    USFDA APPLICATION NUMBER - 203340

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    ABOUT THIS PAGE

    Nimodipine Manufacturers

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

    Nimodipine Suppliers

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

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    Nimodipine USDMF

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

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

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

    Nimodipine KDMF

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

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

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

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

    Nimodipine CEP

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

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

    Nimodipine WC

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

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

    Nimodipine 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 Nimodipine as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Nimodipine GMP

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

    Nimodipine CoA

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

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

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