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Chemistry

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Also known as: 136434-34-9, Duloxetine hcl, Cymbalta, (s)-duloxetine hydrochloride, Ariclaim, Xeristar
Molecular Formula
C18H20ClNOS
Molecular Weight
333.9  g/mol
InChI Key
BFFSMCNJSOPUAY-LMOVPXPDSA-N
FDA UNII
9044SC542W

Duloxetine Hydrochloride
A thiophene derivative and selective NEUROTRANSMITTER UPTAKE INHIBITOR for SEROTONIN and NORADRENALINE (SNRI). It is an ANTIDEPRESSIVE AGENT and ANXIOLYTIC, and is also used for the treatment of pain in patients with DIABETES MELLITUS and FIBROMYALGIA.
1 2D Structure

Duloxetine Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(3S)-N-methyl-3-naphthalen-1-yloxy-3-thiophen-2-ylpropan-1-amine;hydrochloride
2.1.2 InChI
InChI=1S/C18H19NOS.ClH/c1-19-12-11-17(18-10-5-13-21-18)20-16-9-4-7-14-6-2-3-8-15(14)16;/h2-10,13,17,19H,11-12H2,1H3;1H/t17-;/m0./s1
2.1.3 InChI Key
BFFSMCNJSOPUAY-LMOVPXPDSA-N
2.1.4 Canonical SMILES
CNCCC(C1=CC=CS1)OC2=CC=CC3=CC=CC=C32.Cl
2.1.5 Isomeric SMILES
CNCC[C@@H](C1=CC=CS1)OC2=CC=CC3=CC=CC=C32.Cl
2.2 Other Identifiers
2.2.1 UNII
9044SC542W
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Cymbalta

2. Duloxetine

3. Duloxetine Ethanedioate (1:1), (+-)-isomer - T353987

4. Duloxetine Hcl

5. Duloxetine, (+)-isomer

6. Hcl, Duloxetine

7. Hydrochloride, Duloxetine

8. Ly 227942

9. Ly 248686

10. Ly-227942

11. Ly-248686

12. Ly227942

13. Ly248686

14. N-methyl-3-(1-naphthalenyloxy)-2-thiophenepropanamine

15. N-methyl-3-(1-naphthalenyloxy)-3-(2-thiophene)propanamide

2.3.2 Depositor-Supplied Synonyms

1. 136434-34-9

2. Duloxetine Hcl

3. Cymbalta

4. (s)-duloxetine Hydrochloride

5. Ariclaim

6. Xeristar

7. (s)-n-methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine Hydrochloride

8. Duloxetine Hydrochloride [usan]

9. Duloxetine Mylan

10. Duloxetine (hydrochloride)

11. Ly248686 Hcl

12. Ly-248686 Hcl

13. Nsc-759112

14. Cpd000469136

15. Duloxetine (as Hydrochloride)

16. Chebi:31526

17. (3s)-n-methyl-3-naphthalen-1-yloxy-3-thiophen-2-ylpropan-1-amine;hydrochloride

18. 9044sc542w

19. Yentreve (tn)

20. (+)-(s)-n-methyl-gamma-(1-naphthyloxy)-2-thiophenepropylamine Hydrochloride

21. Dsstox_cid_26443

22. Dsstox_rid_81618

23. Dsstox_gsid_46443

24. Duloxetine Boehringer Ingelheim

25. Methyl[3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propyl]amine Hydrochloride

26. (+)-(s)-n-methyl-.gamma.-(1-naphthyloxy)-2-thiophenepropylamine Hydrochloride

27. (s)-n-methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine Hcl

28. Smr000469136

29. Dulane 20

30. Cas-136434-34-9

31. Ncgc00164559-01

32. C18h19nos.hcl

33. Unii-9044sc542w

34. Ly 248686 Hcl

35. Cymbalta (tn)

36. Duloxetina Cloridrato

37. Duloxetine Hydrochlorise

38. Duloxetine Lilly

39. Cloridrato De Duloxetina

40. Clorhidrato De Duloxetina

41. Chlorhydrate De Duloxetine

42. Duloxetine Hcl (cymbalta)

43. Mls001401452

44. Mls006010054

45. (s)-duloxetine (hydrochloride)

46. Duloxetine Hydrochloride- Bio-x

47. Chembl1200328

48. Dtxsid9046443

49. Duloxetine Hydrochloride Solution

50. Duloxetine For System Suitability

51. Hy-b0161a

52. Pharmakon1600-01505387

53. Ly-248686 Hydrochloride

54. Amy12420

55. Duloxetine Hydrochloride (jan/usp)

56. Tox21_112188

57. Ac-924

58. Duloxetine Hydrochloride [mi]

59. Mfcd06407958

60. Nsc744012

61. Nsc759112

62. S2084

63. Duloxetine Hydrochloride [jan]

64. (3s)-n-methyl-3-(1-naphthyloxy)-3-(2-thienyl)propan-1-amine Hydrochloride

65. Akos016340453

66. Tox21_112188_1

67. Ccg-101106

68. Cs-1993

69. Ks-1168

70. Nc00356

71. Nsc 759112

72. Nsc-744012

73. (3s)-n-methyl-3-naphthalen-1-yloxy-3-thiophen-2-ylpropan-1-amine Hydrochloride

74. 2-thiophenepropanamine, N-methyl-gamma-(1-naphthalenyloxy)-, Hydrochloride, (gammas)-

75. 2-thiophenepropanamine, N-methyl-gamma-(1-naphthalenyloxy)-, Hydrochloride, (s)-

76. Duloxetine Hydrochloride [mart.]

77. Duloxetine Hydrochloride [usp-rs]

78. Duloxetine Hydrochloride [who-dd]

79. Ncgc00164559-03

80. (s)-(+)-duloxetine Hydrochloride

81. Bd165546

82. Ly-264453

83. D-170

84. D4223

85. Sw197393-3

86. Duloxetine Hydrochloride [orange Book]

87. (s)-duloxetine Hydrochloride, >=98% (hplc)

88. D01179

89. Duloxetine Hydrochloride [ep Monograph]

90. Duloxetine Hydrochloride [usp Monograph]

91. 434d349

92. Q-102508

93. Duloxetine Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)

94. (+)-(s)-n-methyl-3-(1-naphthyloxy)-3-(2-thienyl)propanamine Hydrochloride

95. Duloxetine Hydrochloride, European Pharmacopoeia (ep) Reference Standard

96. (+)-(s)-n-methyl-3-(1-naphthyloxy)- 3-(2-thienyl)propanamine Hydrochloride

97. (3s)-n-methyl-3-(naphthalen-1-yloxy)-3-(2-thienyl)propan-1-amine Hydrochloride

98. (3s)-n-methyl-3-naphthalen-1-yloxy-3-thiophen-2-ylpropan-1-amin Hydrochloride.

99. (gammas)-2-thiophenepropanamine, N-methyl-gamma-(1-naphthalenyloxy)hydrochloride (1:1)

100. (gammas)-n-methyl-gamma-(1-naphthalenyloxy)-2-thiophenepropanamine Hydrochloride

101. (s)-(+)-n-methyl-3-(1-naphthalenyloxy)-3-(2-thienyl) Propanamine Hydrochloride

102. (s)-(+)-n-methyl-3-(1-naphthyloxy)-3-(2-thienyl)propylamine Hydrochloride

103. 2-thiophenepropanamine, N-methyl-.gamma.-(1-naphthalenyloxy)-, Hydrochloride, (s)-

104. Duloxetine For System Suitability, European Pharmacopoeia (ep) Reference Standard

105. Duloxetine Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

106. Duloxetine Hydrochloride, United States Pharmacopeia (usp) Reference Standard

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 333.9 g/mol
Molecular Formula C18H20ClNOS
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count3
Rotatable Bond Count6
Exact Mass333.0954131 g/mol
Monoisotopic Mass333.0954131 g/mol
Topological Polar Surface Area49.5 Ų
Heavy Atom Count22
Formal Charge0
Complexity312
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameCymbalta
PubMed HealthDuloxetine (By mouth)
Drug ClassesAntidepressant, Central Nervous System Agent, Neuropathic Pain Agent
Drug LabelCymbalta (Duloxetine Delayed-Release Capsules) is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-( )- -methyl--(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The e...
Active IngredientDuloxetine hydrochloride
Dosage FormCapsule, delayed rel pellets
Routeoral; Oral
Strengtheq 30mg base; eq 20mg base; eq 60mg base
Market StatusPrescription
CompanyLilly

2 of 4  
Drug NameDuloxetine hydrochloride
Drug LabelCymbalta (Duloxetine Delayed-Release Capsules) is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-( )- -methyl--(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The e...
Active IngredientDuloxetine hydrochloride
Dosage FormCapsule, delayed rel pellets; Capsule, delayed release
Routeoral; Oral
Strengtheq 40mg base; 60mg; 30mg; eq 30mg base; eq 20mg base; eq 60mg base; 20mg
Market StatusTentative Approval; Prescription
CompanyWockhardt; Actavis Elizabeth; Breckenridge Pharm; Apotex; Alembic Pharms; Teva Pharms Usa; Aurobindo Pharma; Torrent Pharms; Zydus Pharms Usa; Lupin; Dr Reddys Labs; Sandoz; Sun Pharma Global; Impax Labs

3 of 4  
Drug NameCymbalta
PubMed HealthDuloxetine (By mouth)
Drug ClassesAntidepressant, Central Nervous System Agent, Neuropathic Pain Agent
Drug LabelCymbalta (Duloxetine Delayed-Release Capsules) is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-( )- -methyl--(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The e...
Active IngredientDuloxetine hydrochloride
Dosage FormCapsule, delayed rel pellets
Routeoral; Oral
Strengtheq 30mg base; eq 20mg base; eq 60mg base
Market StatusPrescription
CompanyLilly

4 of 4  
Drug NameDuloxetine hydrochloride
Drug LabelCymbalta (Duloxetine Delayed-Release Capsules) is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-( )- -methyl--(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The e...
Active IngredientDuloxetine hydrochloride
Dosage FormCapsule, delayed rel pellets; Capsule, delayed release
Routeoral; Oral
Strengtheq 40mg base; 60mg; 30mg; eq 30mg base; eq 20mg base; eq 60mg base; 20mg
Market StatusTentative Approval; Prescription
CompanyWockhardt; Actavis Elizabeth; Breckenridge Pharm; Apotex; Alembic Pharms; Teva Pharms Usa; Aurobindo Pharma; Torrent Pharms; Zydus Pharms Usa; Lupin; Dr Reddys Labs; Sandoz; Sun Pharma Global; Impax Labs

4.2 Drug Indication

- Treatment of major depressive disorder;

- Treatment of diabetic peripheral neuropathic pain;

- Treatment of generalised anxiety disorder;

- Duloxetine Mylan is indicated in adults.


Duloxetine Lilly is indicated in adults for:

- Treatment of major depressive disorder

- Treatment of diabetic peripheral neuropathic pain

- Treatment of generalised anxiety disorder

Duloxetine Lilly is indicated in adults.


Yentreve is indicated for women for the treatment of moderate to severe stress urinary incontinence (SUI).


Treatment of major depressive disorder.

Treatment of diabetic peripheral neuropathic pain.

Treatment of generalised anxiety disorder.

Cymbalta is indicated in adults.


Treatment of diabetic peripheral neuropathic pain.

Ariclaim is indicated in adults.


Treatment of diabetic peripheral neuropathic pain in adults.


Treatment of chronic pain, Treatment of diabetic neuropathic pain, Treatment of generalised anxiety disorder, Treatment of major depressive disorder, Treatment of stress urinary incontinence


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Antidepressive Agents

Mood-stimulating drugs used primarily in the treatment of affective disorders and related conditions. Several MONOAMINE OXIDASE INHIBITORS are useful as antidepressants apparently as a long-term consequence of their modulation of catecholamine levels. The tricyclic compounds useful as antidepressive agents (ANTIDEPRESSIVE AGENTS, TRICYCLIC) also appear to act through brain catecholamine systems. A third group (ANTIDEPRESSIVE AGENTS, SECOND-GENERATION) is a diverse group of drugs including some that act specifically on serotonergic systems. (See all compounds classified as Antidepressive Agents.)


Analgesics

Compounds capable of relieving pain without the loss of CONSCIOUSNESS. (See all compounds classified as Analgesics.)


Serotonin and Noradrenaline Reuptake Inhibitors

Drugs that selectively block or suppress the plasma membrane transport of SEROTONIN and NORADRENALINE into axon terminals and are used as ANTIDEPRESSIVE AGENTS. (See all compounds classified as Serotonin and Noradrenaline Reuptake Inhibitors.)


Dopamine Agents

Any drugs that are used for their effects on dopamine receptors, on the life cycle of dopamine, or on the survival of dopaminergic neurons. (See all compounds classified as Dopamine Agents.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Serotonin Uptake Inhibitors [MoA]; Serotonin and Norepinephrine Reuptake Inhibitor [EPC]; Norepinephrine Uptake Inhibitors [MoA]
5.3 ATC Code

N06AX21


N06AX21


N06AX21


N06AX21


N06AX21


N06AX21


EU WC

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Duloxetine Hydrochloride (Ph. Eur.)

Date of Issue : 2022-06-17

Valid Till : 2025-07-02

Written Confirmation Number : WC-0082

Address of the Firm : API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, G...

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Duloxetine Hydrochloride (Ph. Eur)

Date of Issue : 2019-06-26

Valid Till : 2022-06-25

Written Confirmation Number : WC-0023

Address of the Firm : Sy.No.1/22, 2/1 To 5, 6 to 18, 61 to 69, Pydibhimavaram Village, Ranasthalam, Sr...

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Duloxetine Hydrochloride EP/ USP

Date of Issue : 2022-06-24

Valid Till : 2025-07-02

Written Confirmation Number : WC-0097

Address of the Firm : Block No. 251/P, 252/P, 253 to 255, 256/P,258/P, 276/P, 277/P, 278/P, 279 To 282...

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Hetero Drugs

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Duloxetine Hydrochloride (Ph. Eur/IH/USP)

Date of Issue : 2022-07-04

Valid Till : 2025-07-03

Written Confirmation Number : WC-0040

Address of the Firm : Unit-I, Survey No.213, 214 & 255,  Bonthapally Village, Jinnaram Mandal, Medak ...

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Lupin Ltd

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Duloxetine Hydrochloride (IH)

Date of Issue : 2022-09-30

Valid Till : 2025-09-10

Written Confirmation Number : WC-0201

Address of the Firm : T-142, MIDC, Tarapur, Vil: Boisar, Dist: Thane-401 506, Maharashtra State

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Duloxetine Hydrochloride (EP/USP)

Date of Issue : 2019-11-28

Valid Till : 2022-07-02

Written Confirmation Number : WC-0079

Address of the Firm : Plot No.2209, GIDC, Industrial Estate, At & Post Sarigam, Tal-Umbergaon, Valsad-...

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Duloxetine Hydrochloride (USP/EP)

Date of Issue : 2022-05-02

Valid Till : 2025-07-25

Written Confirmation Number : WC-0027

Address of the Firm : Unit-II, Survey No.14, IDA Gaddapotharam (Village), Kazipally, Jinnaram (Mandal)...

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Duloxetine Hydrochloride BP/USP/EP

Date of Issue : 2019-07-29

Valid Till : 2022-07-29

Written Confirmation Number : WC-0445

Address of the Firm : Plot No. IP No. 27-29, Parts of Sy. Nos 18, 273, 274 & 313, KIADB Industrial Ar...

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Date of Issue : 2019-10-10

Valid Till : 2022-07-02

Written Confirmation Number : WC-0230

Address of the Firm : Plot no. 24, 25 & 26, Phase-1, IDA Jeedimetia, Medchal District-500055, Telangan...

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Viatris

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Duloxetine Hydrochloride (Ph. Eur.)

Date of Issue : 2019-08-05

Valid Till : 2022-08-04

Written Confirmation Number : WC-0118

Address of the Firm : Unit -1, Sy No.10, Gaddapotharam (V), Khazipally Industrial Area,Medak Dist.,A.P...

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18-Jan-2021
31-Mar-2025
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DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - ...DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - EQ 20MG BASE

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DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - ...DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - EQ 60MG BASE

USFDA APPLICATION NUMBER - 21427

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ABOUT THIS PAGE

Looking for 136434-34-9 / Duloxetine API manufacturers, exporters & distributors?

Duloxetine manufacturers, exporters & distributors 1

48

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

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

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

API | Excipient name

Duloxetine

Synonyms

136434-34-9, Duloxetine hcl, Cymbalta, (s)-duloxetine hydrochloride, Ariclaim, Xeristar

Cas Number

136434-34-9

Unique Ingredient Identifier (UNII)

9044SC542W

About Duloxetine

A thiophene derivative and selective NEUROTRANSMITTER UPTAKE INHIBITOR for SEROTONIN and NORADRENALINE (SNRI). It is an ANTIDEPRESSIVE AGENT and ANXIOLYTIC, and is also used for the treatment of pain in patients with DIABETES MELLITUS and FIBROMYALGIA.

Duloxetine HCl Manufacturers

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

Duloxetine HCl Suppliers

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

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

Duloxetine HCl USDMF

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

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

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

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

Duloxetine HCl KDMF

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

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

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

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

Duloxetine HCl CEP

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

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

Duloxetine HCl WC

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

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

Duloxetine HCl 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 Duloxetine HCl as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Duloxetine HCl GMP

Duloxetine HCl 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 Duloxetine HCl 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 Duloxetine HCl GMP manufacturer or Duloxetine HCl GMP API supplier for your needs.

Duloxetine HCl CoA

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

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

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