Suppliers and packagers for generic pharmaceutical drug: DARIFENACIN HYDROBROMIDE

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
Macleods Pharms Ltd	DARIFENACIN	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	207302	ANDA	Macleods Pharmaceuticals Limited	33342-276-07	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-276-07)	2017-07-29
Macleods Pharms Ltd	DARIFENACIN	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	207302	ANDA	Macleods Pharmaceuticals Limited	33342-276-10	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-276-10)	2017-07-29
Macleods Pharms Ltd	DARIFENACIN	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	207302	ANDA	Macleods Pharmaceuticals Limited	33342-276-12	10 BLISTER PACK in 1 CARTON (33342-276-12) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	2017-07-29

DARIFENACIN HYDROBROMIDE: Supplier Landscape for APIs and Intermediates

Last updated: April 23, 2026

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

1. 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.

2. 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.

3. What documents matter most when buying darifenacin hydrobromide API?
   Lot-specific CoA, GMP site information, and impurity profiles aligned to your target specifications.

4. Why does salt form matter in darifenacin sourcing?
   Darifenacin hydrobromide salt form affects solid-state behavior, impurity generation, and downstream formulation performance.

5. 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.

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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/