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Chemistry

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Also known as: 128-62-1, Narcotine, Tusscapine, Methoxyhydrastine, Terbenol, Capval
Molecular Formula
C22H23NO7
Molecular Weight
413.4  g/mol
InChI Key
AKNNEGZIBPJZJG-MSOLQXFVSA-N
FDA UNII
A4C6WE7BZN

Noscapine
A naturally occurring opium alkaloid that is a centrally acting antitussive agent.
1 2D Structure

Noscapine

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(3S)-6,7-dimethoxy-3-[(5R)-4-methoxy-6-methyl-7,8-dihydro-5H-[1,3]dioxolo[4,5-g]isoquinolin-5-yl]-3H-2-benzofuran-1-one
2.1.2 InChI
InChI=1S/C22H23NO7/c1-23-8-7-11-9-14-20(29-10-28-14)21(27-4)15(11)17(23)18-12-5-6-13(25-2)19(26-3)16(12)22(24)30-18/h5-6,9,17-18H,7-8,10H2,1-4H3/t17-,18+/m1/s1
2.1.3 InChI Key
AKNNEGZIBPJZJG-MSOLQXFVSA-N
2.1.4 Canonical SMILES
CN1CCC2=CC3=C(C(=C2C1C4C5=C(C(=C(C=C5)OC)OC)C(=O)O4)OC)OCO3
2.1.5 Isomeric SMILES
CN1CCC2=CC3=C(C(=C2[C@@H]1[C@@H]4C5=C(C(=C(C=C5)OC)OC)C(=O)O4)OC)OCO3
2.2 Other Identifiers
2.2.1 UNII
A4C6WE7BZN
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Capval

2. Capval Tropfen

3. Embonate, Noscapine Hydrogen

4. Hydrochloride, Noscapine

5. Hydrogen Embonate, Noscapine

6. Librochin Prikkelhoest

7. Narcotine

8. Noscapect

9. Noscapine Hydrochloride

10. Noscapine Hydrogen Embonate

11. Prikkelhoest, Librochin

12. Tropfen, Capval

13. Tuscalman

2.3.2 Depositor-Supplied Synonyms

1. 128-62-1

2. Narcotine

3. Tusscapine

4. Methoxyhydrastine

5. Terbenol

6. Capval

7. Coscopin

8. Narcompren

9. Narcosine

10. Noscapin

11. Vadebex

12. (-)-narcotine

13. Narcotin

14. Narkotin

15. Noscapalin

16. Opianine

17. Opianin

18. Narcotussin

19. Longatin

20. Nectadon

21. Nicolane

22. Nipaxon

23. Lyobex

24. Opian

25. Alpha-narcotine

26. O-methylnarcotoline

27. Coscotabs

28. Noscapinum

29. Key-tusscapine

30. Longactin

31. Noscapal

32. Noscapina

33. Hederix (free Base)

34. (-)-alpha-narcotine

35. L-alpha-narcotine

36. Gnoscopine

37. Narcotinum

38. Noscopine

39. (-)-.alpha.-narcotine

40. Nsc 5366

41. Nsc-5366

42. .alpha.-narcotine

43. Dl-narcotine

44. (+/-)-noscapine

45. L-.alpha.-narcotine

46. A4c6we7bzn

47. 8v32u4aoqu

48. Alpha-gnoscopine

49. (3s)-6,7-dimethoxy-3-[(5r)-4-methoxy-6-methyl-5,6,7,8-tetrahydro[1,3]dioxolo[4,5-g]isoquinolin-5-yl]-2-benzofuran-1(3h)-one

50. (s)-6,7-dimethoxy-3-((r)-4-methoxy-6-methyl-5,6,7,8-tetrahydro-[1,3]dioxolo[4,5-g]isoquinolin-5-yl)isobenzofuran-1(3h)-one

51. Chebi:73237

52. Nsc5366

53. (3s)-6,7-dimethoxy-3-[(5r)-4-methoxy-6-methyl-7,8-dihydro-5h-[1,3]dioxolo[4,5-g]isoquinolin-5-yl]-3h-2-benzofuran-1-one

54. Dsstox_cid_3385

55. Dsstox_rid_77007

56. Dsstox_gsid_23385

57. 1(3h)-isobenzofuranone, 6,7-dimethoxy-3-((5r)-5,6,7,8-tetrahydro-4-methoxy-6-methyl-1,3-dioxolo(4,5-g)isoquinolin-5-yl)-, (3s)-rel-

58. 1(3h)-isobenzofuranone, 6,7-dimethoxy-3-(5,6,7,8-tetrahydro-4-methoxy-6-methyl-1,3-dioxolo(4,5-g)-isoquinolin-5-yl), (s-(r*,s*))-

59. 1(3h)-isobenzofuranone, 6,7-dimethoxy-3-(5,6,7,8-tetrahydro-4-methoxy-6-methyl-1,3-dioxolo(4,5-g)isoquinolin-5-yl)-, (r*,s*)-

60. 6035-40-1

61. Narcotine Alkaloid

62. Noskapin

63. .alpha.-gnoscopine

64. Noscapine Dl-form

65. L-alpha-noscapine

66. 8-methoxyhydrastin

67. Coscopin (van)

68. (3s)-6,7-dimethoxy-3-[(5r)-4-methoxy-6-methyl-2h,5h,6h,7h,8h-[1,3]dioxolo[4,5-g]isoquinolin-5-yl]-1,3-dihydro-2-benzofuran-1-one

69. Smr000059119

70. (+-)-noscapine

71. (-)-.alpha.-norcotine

72. (-)-alpha-norcotine

73. (+-)-alpha-narcotine

74. 1(3h)-isobenzofuranone, 6,7-dimethoxy-3-(5,6,7,8-tetrahydro-4-methoxy-6-methyl-1,3-dioxolo(4,5-g)isoquinolin-5-yl)-, (s-(r*,s*))-

75. 1(3h)-isobenzofuranone, 6,7-dimethoxy-3-(5,6,7,8-tetrahydro-4-methoxy-6-methyl-1,3-dioxolo[4,5-g]isoquinolin-5-yl)-, [s-(r*,s*)]-

76. Noscapinum [inn-latin]

77. Noscapina [inn-spanish]

78. Unii-a4c6we7bzn

79. Unii-8v32u4aoqu

80. Ccris 9304

81. Nsc-96350

82. Hsdb 3372

83. Noscapine [usp:inn:ban:jan]

84. .beta.-narcotine

85. Noscapine (tn)

86. (-)-noscapine

87. Ncgc00016388-01

88. [s-(r*,s*)]-6,7-dimethoxy-3-(5,6,7,8-tetrahydro-4-methoxy-6-methyl-1,3-dioxolo[4,5-g]isoquinolin-5-yl)-1(3h)-isobenzofuranone

89. Cas-128-62-1

90. Prestwick_959

91. (-)-a-narcotine

92. Einecs 204-899-2

93. Nsc 96350

94. 1-.alpha.-narcotine

95. Brn 0099933

96. Tocris-1697

97. Narcotine, (+-)-

98. Noscapine [inn]

99. Noscapine [jan]

100. Noscapine [mi]

101. Noscapine [hsdb]

102. Prestwick0_000563

103. Prestwick1_000563

104. Prestwick2_000563

105. Prestwick3_000563

106. Narcotinum [hpus]

107. Cbmicro_048259

108. Noscapine [mart.]

109. Noscapine [usp-rs]

110. Noscapine [who-dd]

111. Noscapine [who-ip]

112. Schembl4559

113. (s,r)-noscapine, 97%

114. Lopac0_000840

115. Bspbio_000346

116. 4-27-00-06838 (beilstein Handbook Reference)

117. Mls000069475

118. Mls001060855

119. Spbio_002565

120. Noscapine (jp15/usp/inn)

121. Noscapine (jp17/usp/inn)

122. Bpbio1_000382

123. Chembl364713

124. Noscapine Dl-form [mi]

125. Dtxsid4023385

126. Noscapine [ep Monograph]

127. Noscapine, (+/-)-

128. Gtpl10212

129. Noscapine [usp Monograph]

130. Noscapinum [who-ip Latin]

131. Dtxsid901032089

132. Hms1569b08

133. Hms2096b08

134. Hms2269p05

135. 1(3h)-isobenzofuranone, 6,7-dimethoxy-3-((5r)-5,6,7,8-tetrahydro-4-methoxy-6-methyl-1,3-dioxolo(4,5-g)isoquinolin-5-yl)-, (3s)-

136. 6,7-dimethoxy-3-(4-methoxy-6-methyl-5,6,7,8-tetrahydro[1,3]dioxolo[4,5-g]isoquinolin-5-yl)-2-benzofuran-1(3h)-one, (s-(r*,s*))- #

137. Phthalide, 6,7-dimethoxy-3-(5,6,7,8-tetrahydro-4-methoxy-6-methyl-1,3-dioxolo(4,5-g)isoquinolin-5-yl)-

138. (+/-)-.alpha.-narcotine

139. Tox21_110413

140. Bbl012344

141. Bdbm50424716

142. Mfcd00069316

143. Nsc121869

144. Stk054401

145. Zinc19418974

146. Noscapine 1.0 Mg/ml In Acetonitrile

147. Akos000278036

148. Tox21_110413_1

149. Ccg-204096

150. Cs-5115

151. Db06174

152. Nsc-121869

153. Sdccgsbi-0048054.p004

154. (-)-3-(2-methyl-6,7-methylendioxy-8-methoxy-1-isochinolyl)-6,7-dimethoxyphthalid

155. Ncgc00023230-02

156. Ncgc00023230-04

157. Ncgc00023230-05

158. Ncgc00023230-07

159. Ncgc00023230-08

160. Ncgc00023230-10

161. Ncgc00023230-14

162. (3s)-6,7-dimethoxy-3-[(5r)-4-methoxy-6-methyl-5,6,7,8-tetrahydro-2h-[1,3]dioxolo[4,5-g]isoquinolin-5-yl]-2-benzofuran-1(3h)-one

163. (3s)-6,7-dimethoxy-3-[(5r)-5,6,7,8-tetrahydro-4-methoxy-6-methyl-1,3-dioxolo[4,5-g]isoquinolin-5-yl]-1(3h)-isobenzofuranone

164. 5-(6,7-dimethoxyphthalidyl)-5,6,7,8-tetrahydro-4-methoxy-8-methyl-1,3-dioxolo(4,5-g)isoquinoline

165. Ac-20272

166. Ac-33191

167. Hy-13716

168. L-alpha-2-methyl-8-methoxy-6,7-methylenedioxy-1-(6,7-dimethoxy-3-phthalidyl)-1,2,3,4-tetrahydroisoquinaline

169. Nci60_004322

170. Vs-03291

171. Bim-0048054.p001

172. C09592

173. D01036

174. Sr-01000075529-6

175. W-201012

176. Brd-k89237706-001-03-8

177. Q60998699

178. Noscapine, European Pharmacopoeia (ep) Reference Standard

179. Noscapine, United States Pharmacopeia (usp) Reference Standard

180. Wln: T C566 Do Fo Kn Eh & & Tj Ho1 K1 J-dt56 Bvo Dhj Ho1 Io1

181. (3s)-3-[(5r)-6-methyl-4-(methyloxy)-5,6,7,8-tetrahydro[1,3]dioxolo[4,5-g]isoquinolin-5-yl]-6,7-bis(methyloxy)-2-benzofuran-1(3h)-one

182. (3s)-6,7-dimethoxy-3-[(5r)-4-methoxy-6-methyl-7,8-dihydro-5h-[1,3]dioxolo[4,5-g]isoquinolin-5-yl]-3h-isobenzofuran-1-one

183. 08n

184. 1(3h)-isobenzofuranone, 6,7-dimethoxy-3-(5,6,7,8-tetrahydro-4-methoxy-6-methyl-1,3-dioxolo(4,5-g)isoquinolin-5-yl)-, (r*,s*)-(+-)-

185. 1(3h)-isobenzofuranone,7-dimethoxy-3-(5,6,7,8-tetrahydro-4-methoxy-6-methyl-1,3-dioxolo[4,5-g]isoquinolin-5-yl)-, [s-(r*,s*)]-

186. Phthalide,7-dimethoxy-3-(5,6,7,8-tetrahydro-4-methoxy-6-methyl-1,3-dioxolo[4,5-g]isoquinolin-5-yl)-

2.4 Create Date
2005-03-26
3 Chemical and Physical Properties
Molecular Weight 413.4 g/mol
Molecular Formula C22H23NO7
XLogP32.7
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count8
Rotatable Bond Count4
Exact Mass413.14745207 g/mol
Monoisotopic Mass413.14745207 g/mol
Topological Polar Surface Area75.7 Ų
Heavy Atom Count30
Formal Charge0
Complexity647
Isotope Atom Count0
Defined Atom Stereocenter Count2
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

Antitussive Agents

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


ANTITUSSIVE AGENT WHICH DEPRESSES MEDULLARY CENTERS & SUPPRESSES COUGH REFLEX. IT IS USED IN MGMNT OF COUGH IN BRONCHIAL ASTHMA & PULMONARY EMPHYSEMA. DRUG REDUCES FREQUENCY & INTENSITY OF COUGHING PAROXYSMS.

Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 805


DRUG HAS NO MORPHINE-LIKE EFFECTS & HAS NO EFFECT ON MORPHNE ABSTINENCE SYNDROME. TOLERANCE TO ANTITUSSIVE EFFECT HAS NOT BEEN OBSERVED. NOSCAPINE IS NO LONGER CONTROLLED UNDER FEDERAL NARCOTIC LAW.

Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 805


NOSCAPINE HAS NO ANALGESIC PROPERTIES OR DEPENDENCE LIABILITY.

American Medical Association, AMA Department of Drugs, AMA Drug Evaluations. 3rd ed. Littleton, Massachusetts: PSG Publishing Co., Inc., 1977., p. 667


NOSCAPINE HAD NO ANTITUSSIVE ACTIVITY IN VOLUNTEERS.

EMPEY ET AL; COMPARISON OF THE ANTITUSSIVE EFFECTS OF CODEINE PHOSPHATE 20 MG, DEXTROMETHORPHAN 30 MG AND NOSCAPINE 30 MG USING CITRIC ACID-INDUCED COUGH IN NORMAL SUBJECTS; EUR J CLIN PHARMACOL 16(6) 393 (1979)


4.2 Drug Warning

THERAPEUTICALLY EFFECTIVE DOSES ARE ESSENTIALLY DEVOID OF UNPLEASANT SIDE EFFECTS OF CODEINE &, EXCEPT FOR OCCASIONAL NAUSEA, ITS SIDE EFFECTS ARE NEGLIGIBLE. DOSES UP TO 90 MG HAVE NO EFFECT ON RESPIRATION IN MAN.

Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 805


SIDE EFFECTS, PREDOMINANTLY GI, ARE SEEN IN UP TO 30% OF PT STUDIED.

Miller, R. R., and D. J. Greenblatt. Handbook of Drug Therapy. New York: Elsevier North Holland, 1979., p. 988


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

Report of the American Academy of Pediatrics Committee on Drugs in Pediatrics 93 (1): 141 (1994)


4.3 Drug Indication

Investigated for use/treatment in lymphoma (non-hodgkin's), leukemia (lymphoid), cancer/tumors (unspecified), and multiple myeloma.


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Antitussive Agents

Agents that suppress cough. They act centrally on the medullary cough center. EXPECTORANTS, also used in the treatment of cough, act locally. (See all compounds classified as Antitussive Agents.)


5.2 ATC Code

R - Respiratory system

R05 - Cough and cold preparations

R05D - Cough suppressants, excl. combinations with expectorants

R05DA - Opium alkaloids and derivatives

R05DA07 - Noscapine


5.3 Absorption, Distribution and Excretion

ITS ANTITUSSIVE POTENCY & ONSET & DURATION OF ACTION ARE APPROX EQUAL, MG FOR MG, TO THOSE OF CODEINE.

Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 805


5.4 Metabolism/Metabolites

MECONIN WAS THE MAJOR URINARY METABOLITE OF RATS, RABBITS, & HUMANS WHO HAD RECEIVED 120, 150 MG/KG & 10 MG, RESPECTIVELY, ORALLY. IT ACCOUNTED FOR APPROX 3, 8, & 2% OF DOSE RESPECTIVELY, AFTER 24 HR. O-DEMETHYLATED METABOLITES WERE ALSO FOUND.

TSUNODA, YOSHIMURA; XENOBIOTICA 9(3) 181 (1979)


5.5 Mechanism of Action

Noscapine's antitussive effects appear to be primarily mediated by its sigma receptor agonist activity. Evidence for this mechanism is suggested by experimental evidence in rats. Pretreatment with rimcazole, a sigma specific antagonist, causes a dose-dependent reduction in antitussive activity of noscapine.


...EXCEPT FOR ITS ANTITUSSIVE EFFECT, IT HAS NO SIGNIFICANT ACTIONS ON CNS IN DOSES WITHIN THERAPEUTIC RANGE.

Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 279


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PHARMA","supplierCountry":"INDIA","foreign_port":"BASLE","customer":"A.R.PHARM","customerCountry":"SWITZERLAND","quantity":"103.00","actualQuantity":"103","unit":"KGS","unitRateFc":"865","totalValueFC":"87175","currency":"USD","unitRateINR":71422.757281553393,"date":"07-Nov-2024","totalValueINR":"7356544","totalValueInUsd":"87175","indian_port":"Hyderabad Air","hs_no":"29391900","bill_no":"5409890","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"DOOR NO 11-4-3\/4, G F-2, VRIDHI CHAMBERS, OPP: TDP PARTY OFFICE,, Visakhapatnam","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731868200,"product":"NOSCAPINE BP","address":"DOOR NO 11-4-3\/4, G F-2, VRIDHI CHAMBERS, OPP: TDP PARTY OFFICE,","city":"Visakhapatnam","supplier":"A TEAM PHARMA","supplierCountry":"INDIA","foreign_port":"HONG KONG","customer":"FE PHARMACAL CO.,LTD.,","customerCountry":"HONG KONG","quantity":"300.00","actualQuantity":"300","unit":"KGS","unitRateFc":"835","totalValueFC":"247665","currency":"USD","unitRateINR":69666.666666666672,"date":"18-Nov-2024","totalValueINR":"20900000","totalValueInUsd":"247665","indian_port":"Hyderabad Air","hs_no":"29391900","bill_no":"5696829","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"HONG KONG","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"DOOR NO 11-4-3\/4, G F-2, VRIDHI CHAMBERS, OPP: TDP PARTY OFFICE,, Visakhapatnam","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q3","strtotime":1629311400,"product":"NOSCAPINE BP (BULK DRUG IN POWDER FORM) (SB. NO. 6744717 DT:24\/11\/2020) (RETURN GOODS)","address":"8, BENTINCK STREET,","city":"KOLKATA, WEST BENGAL.","supplier":"DKSH","supplierCountry":"INDIA","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"ALKALOIDS CORPORATION","customerCountry":"INDIA","quantity":"340.00","actualQuantity":"340","unit":"KGS","unitRateFc":"870","totalValueFC":"302232.9","currency":"USD","unitRateINR":"65929","date":"19-Aug-2021","totalValueINR":"22415846.92","totalValueInUsd":"302232.9","indian_port":"KOLKATA","hs_no":"29391900","bill_no":"5111322","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"","customerAddress":"8, BENTINCK STREET,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724783400,"product":"NOSCAPINE PH.EUR (NOP)","address":"18\/1 3 AZAMABAD","city":"HYDERABAD ,ANDHRA PRADESH","supplier":"STERLING DRUG MALAYA ","supplierCountry":"INDIA","foreign_port":"KUALA LUMPUR - INT\\'L","customer":"BIOLOGICAL E","customerCountry":"INDIA","quantity":"0.30","actualQuantity":"0.3","unit":"KGS","unitRateFc":"755","totalValueFC":"229.1","currency":"USD","unitRateINR":"64061.8","date":"28-Aug-2024","totalValueINR":"19218.53","totalValueInUsd":"229.1","indian_port":"Hyderabad Air","hs_no":"29391900","bill_no":"5296981","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"KUALA LUMPUR - INT\\'L","supplierAddress":"LOT 89, JALAN ENGGANG, AMPANG-ULUKELANG INDUSTRIAL ESTATE 680000SELANGOR DARUL EHSAN MY","customerAddress":"18\/1 3 AZAMABAD"}]
06-Jan-2021
18-Nov-2024
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ABOUT THIS PAGE

Noscapine Manufacturers

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

Noscapine Suppliers

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

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

Noscapine USDMF

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

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

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

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

Noscapine CEP

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

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

Noscapine WC

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

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

Noscapine 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 Noscapine as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Noscapine GMP

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

Noscapine CoA

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

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

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