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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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Interquim SA

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Virtual BoothInterquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.

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About the Company : Interquim, founded in 1978, is now part of the Ferrer HealthTech division. Interquim specializes in the development of competitive processes for manufacturing high added-value APIs...

Interquim, founded in 1978, is now part of the Ferrer HealthTech division. Interquim specializes in the development of competitive processes for manufacturing high added-value APIs that meet stringent quality standards. Complying with European environmental and work safety regulations, Interquim’s products are exported to highly regulated pharmaceutical markets. Regulatory bodies and clients have approved its quality system and facilities. With state-of-the-art multi-production plants, drug synthesis, and quality-control labs, Interquim supports clients throughout the entire product lifecycle, from product development to marketing.
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Minakem

France
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Virtual BoothMinakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

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About the Company : MINAKEM is a cGMP custom manufacturer of small molecule API, HPAPI and steroids. All development and manufacturing activities are supported by highly skilled R&D teams, supported b...

MINAKEM is a cGMP custom manufacturer of small molecule API, HPAPI and steroids. All development and manufacturing activities are supported by highly skilled R&D teams, supported by strong analytical and regulatory affairs services. The R&D team has an expertise in process development, organic synthesis, and works under a secrecy agreement to protect your IP. With 3 production sites in Europe and 1 in Canada, Minakem is ready to support your strategic sourcing projects or your reshoring activities. Recently launched commercial generic API: Apixaban, Mirabegron, Fulvestrant, remifentanil, esmolol,
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About the Company : Minakem Montreal is developing and manufacturing small molecules APIs and advanced intermediates, including corticosteroids. Following efficient processes and methodologies, our em...

Minakem Montreal is developing and manufacturing small molecules APIs and advanced intermediates, including corticosteroids. Following efficient processes and methodologies, our employees operate a regularly inspected cGMP facility equipped with reactors ranging from 40 to 7,600 litres. Located in Montreal, Canada, we have contributed to the success of our North-American and international clients since 1964.
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LGM Pharma

U.S.A
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Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
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About the Company : Gonane Pharma, is a contract pharmaceutical company located in Gujarat, India, specializing in the manufacturing and marketing of Corticosteroids, Hormones, Antivirals, and Oncolog...

Gonane Pharma, is a contract pharmaceutical company located in Gujarat, India, specializing in the manufacturing and marketing of Corticosteroids, Hormones, Antivirals, and Oncology products. The company's core strength lies in its dedicated team, and its promoters bring over 25 years of experience in manufacturing, promoting products, and managing audits for regulated markets such as the EU, Mexico, China, Korea, and Russia. GONANE PHARMA is actively engaged in discussions with Japanese customers and anticipates further expansion into additional markets.
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About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
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Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...

Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, driving progress in the pharmaceutical industry. Leveraging our extensive experience and world-class expertise, we deliver one of the most comprehensive API portfolios in the industry with over 350 Products portfolio. Additionally, we provide tailored CDMO services, harnessing our proficiency in diverse technologies to meet our partners' unique needs, ensuring flexibility and excellence in every project.
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Virtual BoothMesochem is focused on incessant innovation along with the R&D of new APIs.

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About the Company : Beijing Mesochem Technology Co. Ltd., which is located in the national economic and technological development area of Yizhuang, China, manufactures pharmaceutical chemicals, fine c...

Beijing Mesochem Technology Co. Ltd., which is located in the national economic and technological development area of Yizhuang, China, manufactures pharmaceutical chemicals, fine chemicals and fundamental chemical materials. It has an efficient research and development team. Beijing Mesochem provides its customers customized development, craft optimization, contract customization and outsourcing services. The company has a well-established industrial base in Weinan, Shanxi Province. The production base features a 20,000 ㎡ plant with a production capacity of over 8,000 MT per year.
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About the Company : Micro Labs Limited is a diversified healthcare company with cutting-edge R&D, advanced manufacturing facilities, and a strong distribution network. It ranks among India's top pharm...

Micro Labs Limited is a diversified healthcare company with cutting-edge R&D, advanced manufacturing facilities, and a strong distribution network. It ranks among India's top pharmaceutical companies, with a leading presence in cardiology, diabetology, anti-infectives, ophthalmology, and pain management. The company is known for its high-quality medicines, including the popular fever management brand, Dolo. Micro Labs continues to grow through innovation, research, and global expansion, delivering healthcare solutions that meet international standards.
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Solifenacin Succinate

About the Company : Guowei Pharmaceutical was established in 2005 and is headquartered in Chengdu High-tech Zone. Its subsidiaries include Chengdu Guowei Biopharmaceutical Co., Ltd., Sichuan Guowei Ph...

Guowei Pharmaceutical was established in 2005 and is headquartered in Chengdu High-tech Zone. Its subsidiaries include Chengdu Guowei Biopharmaceutical Co., Ltd., Sichuan Guowei Pharmaceutical Co., Ltd., and Shanghai Ocuen Biotechnology Co., Ltd. After years of development, Guowei Pharmaceutical has developed into a comprehensive pharmaceutical enterprise integrating R&D, production, and sales. Guowei Pharmaceutical's research and development and sales of products are mainly concentrated in the fields of cardiovascular and cerebrovascular, digestive system, anti-infection, and urinary system.
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02-Jan-2021
29-Mar-2025
KGS
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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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Looking for 242478-38-2 / Solifenacin Succinate API manufacturers, exporters & distributors?

Solifenacin Succinate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Solifenacin Succinate 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 Solifenacin Succinate manufacturer or Solifenacin Succinate supplier for your needs.

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

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

API | Excipient name

Solifenacin Succinate

Synonyms

242478-38-2, Vesicare, Solifenacin (succinate), Solifenacin succinate [usan], Ym-905, Ym 905

Cas Number

242478-38-2

Unique Ingredient Identifier (UNII)

KKA5DLD701

About 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.

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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