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Chemistry

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Also known as: 242478-38-2, Vesicare, Solifenacin (succinate), Solifenacin succinate [usan], Ym-905, Ym 905
Molecular Formula
C27H32N2O6
Molecular Weight
480.6  g/mol
InChI Key
RXZMMZZRUPYENV-VROPFNGYSA-N
FDA UNII
KKA5DLD701

Solifenacin Succinate
A quinuclidine and tetrahydroisoquinoline derivative and selective M3 MUSCARINIC ANTAGONIST. It is used as a UROLOGIC AGENT in the treatment of URINARY INCONTINENCE.
1 2D Structure

Solifenacin Succinate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
[(3R)-1-azabicyclo[2.2.2]octan-3-yl] (1S)-1-phenyl-3,4-dihydro-1H-isoquinoline-2-carboxylate;butanedioic acid
2.1.2 InChI
InChI=1S/C23H26N2O2.C4H6O4/c26-23(27-21-16-24-13-10-18(21)11-14-24)25-15-12-17-6-4-5-9-20(17)22(25)19-7-2-1-3-8-19;5-3(6)1-2-4(7)8/h1-9,18,21-22H,10-16H2;1-2H2,(H,5,6)(H,7,8)/t21-,22-;/m0./s1
2.1.3 InChI Key
RXZMMZZRUPYENV-VROPFNGYSA-N
2.1.4 Canonical SMILES
C1CN2CCC1C(C2)OC(=O)N3CCC4=CC=CC=C4C3C5=CC=CC=C5.C(CC(=O)O)C(=O)O
2.1.5 Isomeric SMILES
C1CN2CCC1[C@H](C2)OC(=O)N3CCC4=CC=CC=C4[C@@H]3C5=CC=CC=C5.C(CC(=O)O)C(=O)O
2.2 Other Identifiers
2.2.1 UNII
KKA5DLD701
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 2(1h)-isoquinolinecarboxylic Acid, 3,4-dihydro-1-phenyl-,1- Azabicyclo(2.2.2)oct-3-yl Ester, (r-(r*,s*))-

2. 905, Ym

3. Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate Monosuccinate

4. Solifenacin

5. Succinate, Solifenacin

6. Vesicare

7. Ym 905

8. Ym905

2.3.2 Depositor-Supplied Synonyms

1. 242478-38-2

2. Vesicare

3. Solifenacin (succinate)

4. Solifenacin Succinate [usan]

5. Ym-905

6. Ym 905

7. Ym905

8. 1-azabicyclo[2.2.2]octan-8-yl (1s)-1-phenyl-3,4-dihydro-1h-isoquinoline-2-carboxylate Butanedioic Acid

9. Ym67905

10. Kka5dld701

11. Ym-67905

12. [(3r)-1-azabicyclo[2.2.2]octan-3-yl] (1s)-1-phenyl-3,4-dihydro-1h-isoquinoline-2-carboxylate;butanedioic Acid

13. Vesikur

14. (s)-(r)-quinuclidin-3-yl 1-phenyl-3,4-dihydroisoquinoline-2(1h)-carboxylate Succinate

15. Chembl1200803

16. Solifenacin Succinate Salt

17. Unii-kka5dld701

18. Vesicare Od

19. Vesicare (tn)

20. Isoprenalinoe Sulfate

21. Vesicare Ls

22. Solifenacin Succinate- Bio-x

23. Mls006010416

24. Schembl109333

25. Chebi:32151

26. Dtxsid30947075

27. Hms3887a13

28. Solifenacin Succinate [mi]

29. Solifenacin Succinate [jan]

30. Ex-a4170

31. Hy-a0002

32. Mfcd00954234

33. S3048

34. Solifenacin Succinate [vandf]

35. Solifenacin Succinate [mart.]

36. Akos015994745

37. Solifenacin Succinate [usp-rs]

38. Solifenacin Succinate [who-dd]

39. Am84825

40. Ccg-269551

41. Cs-0371

42. Ks-1286

43. Solifenacin Succinate (jan/usan/inn)

44. Solifenacin Succinate, >=98% (hplc)

45. [(3r)-1-azabicyclo[2.2.2]octan-3-yl] (1s)-1-phenyl-3,4-dihydro-1h-isoquinoline-2-carboxylate; Butanedioic Acid

46. 2(1h)-isoquinolinecarboxylic Acid, 3,4-dihydro-1-phenyl-, (3r)-1-azabicyclo(2.2.2)oct-3-yl Ester, (1s)-, Butanedioate (1:1)

47. As-35288

48. Bs164410

49. Butanedioic Acid, Cmpd. With (1s)-(3r)-1-azabicyclo(2.2.2)oct-3-yl 3,4-dihydro-1-phenyl-2(1h)-isoquinolinecarboxylate (1:1)

50. Butanedioic Acid, Compd With (1s)-(3r)-1-azabicyclo(2.2.2)oct-3-yl 3,4-dihydro-1-phenyl-2(1h)-isoquinolinecarboxylate (1:1)

51. Smr004701445

52. Ym-53705

53. Solifenacin Succinate [orange Book]

54. Solifenacin Succinate [ep Monograph]

55. S0944

56. Sw219141-1

57. D01269

58. A819262

59. A881133

60. Q374826

61. Solifenacin Succinate, Europepharmacopoeia (ep) Reference Standard

62. Solifenacin Succinate, United States Pharmacopeia (usp) Reference Standard

63. (r)-quinuclidin-3-yl (s)-1-phenyl-3,4-dihydroisoquinoline-2(1h)-carboxylate

64. (s)-(r)-quinuclidin-3-yl1-phenyl-3,4-dihydroisoquinoline-2(1h)-carboxylatesuccinate

65. Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylatemonosuccinate

66. Solifenacin For System Suitability, Europepharmacopoeia (ep) Reference Standard

67. (1s)-(3r)-1-azabicyclo[2.2.2]oct-3-yl-3,4-dihydro-1-phenyl-2(1h)-isoquinolinecarboxylate Succinate

68. 1-azabicyclo[2.2.2]octan-8-yl (1s)-1-phenyl-3,4-dihydro-1h-isoquinoline-2-carboxylate Butanedioic Acid (solifenacin?succinate)

69. Butanedioic Acid--1-azabicyclo[2.2.2]octan-3-yl 1-phenyl-3,4-dihydroisoquinoline-2(1h)-carboxylate (1/1)

70. Butanedioic Acid; (1s)-1-phenyl-3,4-dihydro-1h-isoquinoline-2-carboxylic Acid [(3r)-1-azabicyclo[2.2.2]octan-3-yl] Ester

2.4 Create Date
2005-08-09
3 Chemical and Physical Properties
Molecular Weight 480.6 g/mol
Molecular Formula C27H32N2O6
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count7
Rotatable Bond Count6
Exact Mass480.22603674 g/mol
Monoisotopic Mass480.22603674 g/mol
Topological Polar Surface Area107 Ų
Heavy Atom Count35
Formal Charge0
Complexity617
Isotope Atom Count0
Defined Atom Stereocenter Count2
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 NameSolifenacin succinate
Drug LabelVESIcare (solifenacin succinate) is a muscarinic receptor antagonist. Chemically, solifenacin succinate is butanedioic acid, compounded with (1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H)-iso-quinolinecarboxylate (1:1) having an e...
Active IngredientSolifenacin succinate
Dosage FormTablet
RouteOral
Strength5mg; 10mg
Market StatusPrescription
CompanyTeva Pharms Usa

2 of 4  
Drug NameVesicare
PubMed HealthSolifenacin (By mouth)
Drug ClassesUrinary Antispasmodic
Drug LabelVESIcare (solifenacin succinate) is a muscarinic receptor antagonist. Chemically, solifenacin succinate is butanedioic acid, compounded with (1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H)-iso-quinolinecarboxylate (1:1) having an e...
Active IngredientSolifenacin succinate
Dosage FormTablet
RouteOral
Strength5mg; 10mg
Market StatusPrescription
CompanyAstellas

3 of 4  
Drug NameSolifenacin succinate
Drug LabelVESIcare (solifenacin succinate) is a muscarinic receptor antagonist. Chemically, solifenacin succinate is butanedioic acid, compounded with (1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H)-iso-quinolinecarboxylate (1:1) having an e...
Active IngredientSolifenacin succinate
Dosage FormTablet
RouteOral
Strength5mg; 10mg
Market StatusPrescription
CompanyTeva Pharms Usa

4 of 4  
Drug NameVesicare
PubMed HealthSolifenacin (By mouth)
Drug ClassesUrinary Antispasmodic
Drug LabelVESIcare (solifenacin succinate) is a muscarinic receptor antagonist. Chemically, solifenacin succinate is butanedioic acid, compounded with (1S)-(3R)-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1H)-iso-quinolinecarboxylate (1:1) having an e...
Active IngredientSolifenacin succinate
Dosage FormTablet
RouteOral
Strength5mg; 10mg
Market StatusPrescription
CompanyAstellas

4.2 Drug Indication

Treatment of neurogenic detrusor overactivity


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Urological Agents

Drugs used in the treatment of urological conditions and diseases such as URINARY INCONTINENCE and URINARY TRACT INFECTIONS. (See all compounds classified as Urological Agents.)


Muscarinic Antagonists

Drugs that bind to but do not activate MUSCARINIC RECEPTORS, thereby blocking the actions of endogenous ACETYLCHOLINE or exogenous agonists. Muscarinic antagonists have widespread effects including actions on the iris and ciliary muscle of the eye, the heart and blood vessels, secretions of the respiratory tract, GI system, and salivary glands, GI motility, urinary bladder tone, and the central nervous system. (See all compounds classified as Muscarinic Antagonists.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Cholinergic Muscarinic Antagonists [MoA]; Cholinergic Muscarinic Antagonist [EPC]

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PRERNATIRTH DER NR. RATNADEEP-2, SATELLITE, JODHPUR","city":"AHMEDABAD","supplier":"TECNIMEDE","supplierCountry":"PORTUGAL","foreign_port":"NA","customer":"UNISON PHARMACEUTICALS PRIVATE LIMITED","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"2920","totalValueFC":"2950.3","currency":"USD","unitRateINR":"242506.3","date":"22-Jun-2023","totalValueINR":"242506.292","totalValueInUsd":"2950.3","indian_port":"AHMEDABAD AIR","hs_no":"29333929","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"PORTUGAL","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"UNISON HOUSE, NR. PRERNATIRTH DER NR. RATNADEEP-2, SATELLITE, JODHPUR"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1688063400,"product":"SOLIFENACIN SUCCINATE EP\/ BP \/ IP \/ USP \/ PH.EUR","address":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ","city":"AHMEDABAD,GUJARAT","supplier":"MEDICHEM MANUFACTURING (MALTA) LIMITED","supplierCountry":"MALTA","foreign_port":"NA","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"28.00","actualQuantity":"28","unit":"KGS","unitRateFc":"3100","totalValueFC":"87701.5","currency":"USD","unitRateINR":"257455.3","date":"30-Jun-2023","totalValueINR":"7208740.35","totalValueInUsd":"87701.5","indian_port":"AHMEDABAD AIR","hs_no":"29334900","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"MALTA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1688581800,"product":"SOLIFENACIN SUCCINATE (BATCH NO. A19429M) (QTY:2 DRUMS)","address":"201, MAHAVIR INDL ESTATE, OFF,MAHA KALI CAVES ROAD, ANDHERI EAST","city":"MUMBAI,MAHARASHTRA","supplier":"INTERQUIM SA","supplierCountry":"SPAIN","foreign_port":"NA","customer":"OXALIS LABS","customerCountry":"INDIA","quantity":"8.00","actualQuantity":"8","unit":"KGS","unitRateFc":"4000","totalValueFC":"35235.6","currency":"EUR","unitRateINR":"362000.1","date":"06-Jul-2023","totalValueINR":"2896000.303","totalValueInUsd":"35235.6","indian_port":"BOMBAY AIR","hs_no":"29334900","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"201, MAHAVIR INDL ESTATE, OFF,MAHA KALI CAVES ROAD, ANDHERI EAST"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1697740200,"product":"SOLIFENACINE SUCCINATE ( BATCH NO 15002000000401 )","address":"8-2120\/86\/9\/A\/1,12 & 2\/13,ANILATH,","city":"BANJARA HILLS,TELANGANA","supplier":"UNION QUIMICO FARMACEUTICA ","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"VIVIMED LIFE SCIENCES ","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"2500","totalValueFC":"26838.5","currency":"EUR","unitRateINR":"223375","date":"20-Oct-2023","totalValueINR":"2233750","totalValueInUsd":"26838.5","indian_port":"Madras Air","hs_no":"29334900","bill_no":"8388897","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"MALLORCA,262 08008 BARCELONASDNFSDNF Spain","customerAddress":"8-2120\/86\/9\/A\/1,12 & 2\/13,ANILATH,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1712860200,"product":"6904022 SOLIFENACIN SUCCINATE","address":"21-22, KALPATARU SQUARE, KONDIVITA","city":"ANDHERI (E), MUMBAI,MAHARASHTRA","supplier":"INTERQUIM SA","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"TEVA PHARMACEUTICAL INDUSTRIES","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"2900","totalValueFC":"6393.3","currency":"EUR","unitRateINR":"266945","date":"12-Apr-2024","totalValueINR":"533890","totalValueInUsd":"6393.3","indian_port":"Bombay Air","hs_no":"29334900","bill_no":"2993345","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"JOAN BUSCALLA, 10 08173 SANT CUGATDEL VALLES Barcelona, , SpainSDNF Spain","customerAddress":"21-22, KALPATARU SQUARE, KONDIVITA"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723228200,"product":"SOLIFENACIN SUCCINATE PH. EUR(B\/NO: SS23120011)(EXP. VIDE S\/B NO:7335268,DT: 07-02-2024, INV NO:SI3623124631\/03-02-2024)","address":"7-2-A2, HETERO CORPORATE,","city":"HYDERABAD-A.P.","supplier":"SYNTHON HISPANIA S.L.","supplierCountry":"INDIA","foreign_port":"BARCELONA","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"13.07","actualQuantity":"13.072","unit":"KGS","unitRateFc":"2400","totalValueFC":"32962.6","currency":"USD","unitRateINR":"211509.4","date":"10-Aug-2024","totalValueINR":"2764851.31","totalValueInUsd":"32962.6","indian_port":"Hyderabad Air","hs_no":"29334900","bill_no":"4985018","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"CASTELLO 1,08830 SANT BOI DE LLOBREGATSDNF ES","customerAddress":"7-2-A2, HETERO CORPORATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732473000,"product":"6904022 SOLIFENACIN SUCCINATE CAS RN: 242478-38-2","address":"21-22, KALPATARU SQUARE, KONDIVITA","city":"ANDHERI (E), MUMBAI,MAHARASHTRA","supplier":"INTERQUIM SA","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"TEVA PHARMACEUTICAL INDUSTRIES","customerCountry":"INDIA","quantity":"4.92","actualQuantity":"4.92","unit":"KGS","unitRateFc":"2900","totalValueFC":"15352.1","currency":"EUR","unitRateINR":"263320","date":"25-Nov-2024","totalValueINR":"1295534.4","totalValueInUsd":"15352.1","indian_port":"Bombay Air","hs_no":"29334900","bill_no":"6879578","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"JOAN BUSCALLA, 10 08173 SANT CUGAT DEL VALLES Barcelona SDNF Spain","customerAddress":"21-22, KALPATARU SQUARE, KONDIVITA"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732473000,"product":"6904022 SOLIFENACIN SUCCINATE CAS RN: 242478-38-2","address":"21-22, KALPATARU SQUARE, KONDIVITA","city":"ANDHERI (E), MUMBAI,MAHARASHTRA","supplier":"INTERQUIM SA","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"TEVA PHARMACEUTICAL INDUSTRIES","customerCountry":"INDIA","quantity":"11.08","actualQuantity":"11.08","unit":"KGS","unitRateFc":"2900","totalValueFC":"34573.4","currency":"EUR","unitRateINR":"263320","date":"25-Nov-2024","totalValueINR":"2917585.6","totalValueInUsd":"34573.4","indian_port":"Bombay Air","hs_no":"29334900","bill_no":"6879578","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"JOAN BUSCALLA, 10 08173 SANT CUGAT DEL VALLES Barcelona SDNF Spain","customerAddress":"21-22, KALPATARU SQUARE, KONDIVITA"}]
12-Jan-2021
31-Dec-2024
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 10MG

USFDA APPLICATION NUMBER - 21518

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DOSAGE - TABLET;ORAL - 5MG

USFDA APPLICATION NUMBER - 21518

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ABOUT THIS PAGE

Solifenacin Succinate Manufacturers

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

Solifenacin Succinate Suppliers

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

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

Solifenacin Succinate USDMF

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

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

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

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

Solifenacin Succinate KDMF

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

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

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

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

Solifenacin Succinate CEP

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

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

Solifenacin Succinate WC

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

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

Solifenacin Succinate 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 Solifenacin Succinate as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Solifenacin Succinate GMP

Solifenacin Succinate 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 Solifenacin Succinate 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 Solifenacin Succinate GMP manufacturer or Solifenacin Succinate GMP API supplier for your needs.

Solifenacin Succinate CoA

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

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

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