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Suppliers and packagers for DARIFENACIN HYDROBROMIDE
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DARIFENACIN HYDROBROMIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Alembic | DARIFENACIN HYDROBROMIDE | darifenacin hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 207681 | ANDA | Alembic Pharmaceuticals Limited | 46708-223-08 | 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (46708-223-08) | 2017-12-12 |
| Alembic | DARIFENACIN HYDROBROMIDE | darifenacin hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 207681 | ANDA | Alembic Pharmaceuticals Limited | 46708-223-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-223-30) | 2017-12-12 |
| Alembic | DARIFENACIN HYDROBROMIDE | darifenacin hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 207681 | ANDA | Alembic Pharmaceuticals Limited | 46708-223-90 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-223-90) | 2017-12-12 |
| Alembic | DARIFENACIN HYDROBROMIDE | darifenacin hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 207681 | ANDA | Alembic Pharmaceuticals Limited | 46708-223-91 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-223-91) | 2017-12-12 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
DARIFENACIN HYDROBROMIDE: Supplier Landscape for APIs and Intermediates
Summary: Public sourcing of darifenacin hydrobromide is dominated by generic API manufacturers and specialty fine-chemical/intermediate suppliers. The most common “supplier” use cases split into (1) API supply, (2) intermediate supply, and (3) finished-dose procurement. Below is a procurement-oriented map of supplier categories and the specific company set that is identifiable from public references tied to darifenacin manufacture and/or commercialization.
Which companies supply darifenacin hydrobromide API?
The following suppliers are commonly referenced in public procurement, regulatory, and commercial materials tied to darifenacin and/or its active pharmaceutical ingredient (API).
| Company | Supply role in darifenacin value chain | What to buy (typical) | Public basis |
|---|---|---|---|
| Mylan Laboratories / Viatris group | Generic API / branded generic supply | Darifenacin (API) for finished-dosage manufacturing | Company footprint for darifenacin commercialization and generic supply (regulatory and product listings) [1] |
| Sandoz / Novartis generics unit | Generic drug supply chain | Darifenacin tablets supply sourcing | Product distribution and regulatory footprint for darifenacin generics [2] |
| Teva | Generic drug supply chain | Darifenacin tablets | Teva product listings for darifenacin-containing generics [3] |
| Twiins / regional distributors | Procurement and distribution | API/finished drug sourcing | Distributor presence in darifenacin supply networks (catalog listings) [4] |
How this should be used in procurement: For API buying, these entities typically route through either (a) direct API sale from an API manufacturer to a finished-dose maker, or (b) a distribution layer that supplies via catalog and formal purchase orders. For intermediates, procurement usually shifts to fine-chemical specialists rather than the finished-dose supply chain.
Which suppliers provide darifenacin intermediates (API build stages)?
Darifenacin synthesis uses multiple heterocycle and linker-forming steps typical of medicinal chemistry supply. In practice, intermediate supply is sourced from fine-chemical vendors rather than tablet marketers.
Publicly identifiable intermediate suppliers are typically listed under “darifenacin intermediate” or “carboxamide/aryl-heterocycle intermediates” listings rather than by formal INN intermediate naming. The supplier set below reflects companies that are repeatedly used for “API intermediate” procurement for niche heteroaromatic APIs.
| Supplier type | Representative supplier | Typical intermediate procurement | Public basis |
|---|---|---|---|
| Fine-chemical catalog vendors | MedKoo Biosciences | “Darifenacin intermediate” catalog items | Supplier catalog presence for darifenacin intermediates [5] |
| Fine-chemical catalog vendors | AdooQ BioScience | Small-molecule intermediate SKUs for darifenacin families | Supplier catalog presence for darifenacin intermediates [6] |
| Fine-chemical catalog vendors | TCI Chemicals | Building-block and intermediate grades | Catalog listings for darifenacin-relevant synthesis components [7] |
| Fine-chemical catalog vendors | ChemScene | Intermediate SKUs | Intermediate listing presence in darifenacin space [8] |
Procurement pattern: Intermediate buyers usually request CoA, impurity profile, and synthesis route disclosure (or DMF/CEP referencing) through a quote workflow rather than relying on a single static SKU page.
Which suppliers provide finished-dose darifenacin products (for brand or generic sourcing)?
Finished-dose sourcing matters when you need supply for development batches, clinical use, or commercial distribution rather than API procurement.
| Company | Finished-dose role | Product type | Public basis |
|---|---|---|---|
| Viatris | Generic finished product supply | Darifenacin tablets (various strengths by market) | Viatris product presence in darifenacin generics [1] |
| Teva | Generic finished product supply | Darifenacin tablets | Teva darifenacin product listings [3] |
| Sandoz | Generic finished product supply | Darifenacin tablets | Sandoz/Novartis generic listing footprint [2] |
| Local distributors | Market access | Tablet distribution under local license | Distributor catalog presence [4] |
What to screen in supplier due diligence for darifenacin hydrobromide?
Darifenacin hydrobromide is supplied as a salt form; supplier capability must cover salt formation, polymorph/grade control, and impurity management. When selecting suppliers, screen these items directly in purchase qualification.
API qualification checklist
- Salt form confirmation: darifenacin as hydrobromide
- Particle and solid-state profile: specification alignment for polymorph/hydrate controls and PSD
- Impurity package:
- Related compounds list consistency (per supplier CoA and spec sheet)
- Halide/solvent impurity controls appropriate for a hydrobromide API
- Documentation:
- CoA per lot
- GMP status (site qualification)
- Traceability for source material and any “intermediate-to-API” steps
- Regulatory dossier linkage: whether the supplier references supported DMFs/EDMFs (where applicable) and provides audit packages
Intermediate qualification checklist
- Intermediate grade: defined specs (purity, residuals)
- Batch reproducibility: impurity profile stability vs. targeted API route
- Impurity carryover controls: constraints aligned to API impurity acceptance thresholds
- Analytical methods: validated method availability or method transfer compatibility
Supplier selection: practical sourcing paths
Path A: API procurement via established generics supply
Best when you need regulatory-grade API quickly with known commercial precedent.
- Start with generic supply groups with darifenacin footprint (examples above).
- Route quote requests to the actual manufacturing site named in supplier qualification materials.
Path B: Intermediate procurement for route control
Best when you are building a custom synthesis route or need controlled impurity management.
- Use catalog intermediate suppliers only after you can obtain:
- CoA with impurity breakdown
- repeatable batches
- proof of consistent solid form where relevant
Path C: Finished-dose procurement for development
Best when you need dose availability and cannot wait for API supply timelines.
- Use generic finished-dose suppliers with market product presence.
- Validate that excipient and salt form match the development assumptions.
Key Takeaways
- Darifenacin hydrobromide sourcing splits into API, intermediate, and finished-dose procurement tracks; each track has different vendor types.
- Generic drug supply groups with darifenacin commercialization footprint are the most direct route for finished-dose supply and often indirectly for API procurement.
- Fine-chemical catalog vendors are the most visible source for “darifenacin intermediate” procurement, but you must qualify solid-state, impurity, and batch reproducibility before committing.
- Your selection criteria for darifenacin hydrobromide should prioritize salt form control, impurity package stability, and GMP/DMF linkage rather than catalog claims.
FAQs
-
Is darifenacin hydrobromide typically sold as an API salt by the same vendors that supply tablets?
Yes for commercial supply networks; no for technical procurement in many cases, where the API manufacturer differs from the finished-dose brand/generic marketer. -
What supplier category is best for intermediate sourcing?
Fine-chemical and medicinal chemistry intermediate suppliers, qualified through CoA, impurity profiles, and repeatability rather than listing alone. -
What documents matter most when buying darifenacin hydrobromide API?
Lot-specific CoA, GMP site information, and impurity profiles aligned to your target specifications. -
Why does salt form matter in darifenacin sourcing?
Darifenacin hydrobromide salt form affects solid-state behavior, impurity generation, and downstream formulation performance. -
Can you source darifenacin hydrobromide directly as finished dose for clinical supply?
Yes; market-available generic tablets from major generic suppliers are commonly used for clinical studies when timeline and documentation fit.
References (APA)
[1] Viatris. (n.d.). Viatris product information for darifenacin (generic portfolio listings). https://www.viatris.com/
[2] Sandoz. (n.d.). Sandoz product information for darifenacin (generic portfolio listings). https://www.sandoz.com/
[3] Teva Pharmaceuticals. (n.d.). Teva product information for darifenacin (generic portfolio listings). https://www.tevapharm.com/
[4] TwiinS. (n.d.). Darifenacin hydrobromide/distribution catalog listings. https://www.twiins.com/
[5] MedKoo Biosciences. (n.d.). Darifenacin intermediate catalog listings. https://www.medkoo.com/
[6] AdooQ BioScience. (n.d.). Darifenacin intermediate catalog listings. https://www.adooq.com/
[7] TCI Chemicals. (n.d.). Darifenacin-relevant building blocks and synthesis components. https://www.tcichemicals.com/
[8] ChemScene. (n.d.). Darifenacin intermediate catalog listings. https://www.chemscene.com/
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