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Suppliers and packagers for generic pharmaceutical drug: SOLIFENACIN SUCCINATE
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SOLIFENACIN SUCCINATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Astellas | VESICARE LS | solifenacin succinate | SUSPENSION;ORAL | 209529 | NDA | Astellas Pharma US, Inc. | 51248-250-99 | 1 BOTTLE, PLASTIC in 1 CARTON (51248-250-99) / 150 mL in 1 BOTTLE, PLASTIC | 2020-05-26 |
| Ajanta Pharma Ltd | SOLIFENACIN SUCCINATE | solifenacin succinate | TABLET;ORAL | 205483 | ANDA | Ajanta Pharma USA Inc. | 27241-037-03 | 30 TABLET, FILM COATED in 1 BOTTLE (27241-037-03) | 2019-05-20 |
| Ajanta Pharma Ltd | SOLIFENACIN SUCCINATE | solifenacin succinate | TABLET;ORAL | 205483 | ANDA | Ajanta Pharma USA Inc. | 27241-037-09 | 90 TABLET, FILM COATED in 1 BOTTLE (27241-037-09) | 2019-05-20 |
| Ajanta Pharma Ltd | SOLIFENACIN SUCCINATE | solifenacin succinate | TABLET;ORAL | 205483 | ANDA | Ajanta Pharma USA Inc. | 27241-038-03 | 30 TABLET, FILM COATED in 1 BOTTLE (27241-038-03) | 2019-05-20 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Who Supplies Solifenacin Succinate for Pharmaceutical Drug Production?
Who are the main suppliers/manufacturers of solifenacin succinate APIs?
Solifenacin succinate is commonly sourced from Indian and Chinese API producers and intermediates specialists. Typical supply chains include: (1) API manufacturers who sell solifenacin succinate directly to branded-generic marketers and contract manufacturers, and (2) intermediate producers that feed API synthesis.
Common supplier profile in the solifenacin succinate market
- API manufacturers (end product): sell solifenacin succinate API with standard regulatory support packages (DMF/ASMF where applicable) and batch documentation.
- Contract manufacturers (finished dose): buy API and manufacture tablets/capsules under approved formulations.
- Intermediate manufacturers: supply advanced intermediates used in solifenacin synthesis routes, often under confidential sourcing arrangements.
Representative supplier set used across the solifenacin succinate supply ecosystem The suppliers below are repeatedly associated with solifenacin-related manufacturing or sales activity in the global generics supply chain (API, intermediates, or finished-dose manufacturing), based on established market listings and product catalog presence:
| Supplier type | Company | Geography | What they typically supply for solifenacin |
|---|---|---|---|
| API / generics supply | Amneal Pharmaceuticals | USA | Finished-dose generics distribution; API sourcing through its supply network |
| API / generics supply | Sandoz | Switzerland | Branded generic finished-dose supply (API sourced from qualified suppliers) |
| API / generics supply | Teva | Israel | Finished-dose generics supply chain for solifenacin-based products |
| API / generics supply | Mylan / Viatris | USA | Finished-dose generic supply network |
| API / generics supply | Zydus | India | API and finished-dose manufacturing footprint used for antimuscarinic brands including solifenacin in the generics market |
| API / generics supply | Dr. Reddy’s | India | API and finished-dose footprint for urology antimuscarinics |
| API / generics supply | Torrent Pharmaceuticals | India | Finished-dose generic manufacturing; API sourced from qualified suppliers |
| API / generics supply | Cipla | India | Finished-dose supply; API sourced through qualification network |
| Intermediate / API enabling supply | Shaanxi / Hebei / Zhejiang chemical producers (China) | China | Advanced intermediates feeding solifenacin synthesis routes (supplier names vary by catalog and lot) |
| API / contract supply (India) | Generic API manufacturers in India (DMF/CEP oriented) | India | Solifenacin succinate API supply for generic formulators |
Actionable implication for procurement
- Many branded-generic and finished-dose companies do not publicly list their solifenacin API named sources; their procurement uses qualified supplier networks.
- The most actionable procurement list is built from: (a) DMF/ASMF holders, (b) CEP/CoA-compliant suppliers for solifenacin succinate, and (c) local contract manufacturers in the target regulatory region.
Which companies sell solifenacin succinate API and what procurement signals matter?
For solifenacin succinate API, buyers typically qualify suppliers on the following proof points:
| Procurement signal | What it indicates | Why it matters |
|---|---|---|
| Regulatory file availability (DMF/ASMF/CEP) | filing status and chemistry controls | faster approval cycles for finished-dose manufacturers |
| CoA parameters | identity, assay, related substances, polymorph/solvate control | batch-to-batch consistency |
| Particle size and salt form specification | solifenacin succinate form control | direct impact on dissolution and stability |
| Impurity profile | control of genotoxic/route impurities | reduces regulatory risk during dossier review |
| Sterility and bioburden controls for intermediates (where relevant) | downstream robustness | especially important for scale-up to finished-dose GMP |
| GMP certification scope | authority inspections and site coverage | determines acceptable supplier for regulated markets |
What are typical product specs buyers request for solifenacin succinate API?
Suppliers usually align with monographs and internal specifications. While exact numeric specs vary by supplier, buyers typically request:
- Chemical form: solifenacin succinate (salt)
- Assay: within pharmacopeia and supplier limits
- Related substances: controlled, with route-specific impurities limited below internal thresholds
- Residual solvents: controlled per ICH Q3C
- Water content: controlled for stability and consistent tablet manufacturing
- Particle size: controlled range for compressibility and dissolution
- Polymorph/form: controlled where relevant to consistent performance
- Heavy metals: controlled (ICH Q3D approach)
- Microbial limits: controlled where required by the supplier and intended use
What countries dominate solifenacin succinate sourcing?
The solifenacin succinate API market is heavily supplied by:
- India: large generic API ecosystem with DMF-capable manufacturers and batch-scale flexibility for generics.
- China: intermediate and API producers with scale advantages and dense chemical supply chains.
- EU/US: fewer API suppliers publicly marketed for solifenacin succinate; finished-dose firms typically source globally through qualified networks.
How to map “suppliers” correctly: API vs finished dose vs intermediates
“Supplier for solifenacin succinate” can mean three different procurement targets:
-
API supplier
- Provides solifenacin succinate active substance.
- Best for new formulation, scale-up, and dossier control.
-
Finished-dose manufacturer
- Buys API and manufactures tablets.
- Best when the customer needs a ready-to-market product.
-
Intermediate supplier
- Supplies advanced chemical building blocks used to make solifenacin succinate.
- Best when a sponsor builds or audits its own API synthesis route.
Which procurement pathways are fastest for a new buyer?
- Route A: Qualified API suppliers in India/China with regulatory documentation
- Fastest path for dossier alignment via DMF/ASMF/CEP where available.
- Route B: Finished-dose CDMO that already has solifenacin formulations
- Fastest path to finished dosage with established stability and manufacturing SOPs.
- Route C: Intermediate + own API synthesis
- Typically slowest and highest risk operationally, but controllable for high-volume programs.
Key Takeaways
- Solifenacin succinate supply is primarily anchored in India and China for API and intermediate manufacturing, with EU/US companies sourcing via qualified global supplier networks to produce or market finished-dose generics.
- Practical supplier selection depends on regulatory-file readiness (DMF/ASMF/CEP), CoA impurity and salt-form specifications, and GMP site scope.
- To operationalize “suppliers,” separate API, finished dose, and intermediates; buyers that keep these categories distinct reduce qualification time and regulatory friction.
FAQs
1) Are solifenacin succinate API suppliers the same as finished-dose companies?
No. Finished-dose companies typically source API from qualified external suppliers or corporate chemical affiliates. They are suppliers to the market only for the finished dosage, not necessarily the API.
2) Which documentation matters most when qualifying solifenacin succinate API suppliers?
Regulatory-file documentation (DMF/ASMF/CEP where applicable) and batch-level CoA specs for assay, related substances, residual solvents, water content, and heavy metals.
3) Do solifenacin succinate suppliers provide polymorph or salt-form control data?
Qualified suppliers generally provide salt-form and form-control assurances through specs and manufacturing process controls, since salt form affects dissolution and stability.
4) What is the typical sourcing geography for solifenacin succinate?
Most sourcing activity concentrates in India and China for API and intermediates, with finished-dose manufacturing distributed across US/EU/India platforms.
5) What’s the fastest procurement route: API or finished-dose CDMO?
For speed-to-market, finished-dose CDMO is often faster when the CDMO already runs established manufacturing and stability for solifenacin-based products. API procurement is faster only when the buyer already has formulation and dossier pathways ready.
References
[1] DrugBank. “Solifenacin.” https://go.drugbank.com/drugs/DB00378
[2] European Medicines Agency (EMA). “Solifenacin-containing medicines (product information and EPARs where applicable).” https://www.ema.europa.eu
[3] US FDA. “Drugs@FDA (solifenacin products and regulatory information for finished-dose references).” https://www.accessdata.fda.gov/scripts/cder/daf/
[4] ICH. “Q3C (Residual Solvents) and Q3D (Elemental Impurities) guidelines.” https://www.ich.org
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