bethanechol chloride: Pharmaceutical manufacturers, suppliers, and distributors

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal Pharm	BETHANECHOL CHLORIDE	bethanechol chloride	TABLET;ORAL	040855	ANDA	Amneal Pharmaceuticals of New York LLC	53746-571-01	100 TABLET in 1 BOTTLE (53746-571-01)	2022-04-15
Amneal Pharm	BETHANECHOL CHLORIDE	bethanechol chloride	TABLET;ORAL	040855	ANDA	Amneal Pharmaceuticals of New York LLC	53746-572-01	100 TABLET in 1 BOTTLE (53746-572-01)	2022-04-15
Amneal Pharm	BETHANECHOL CHLORIDE	bethanechol chloride	TABLET;ORAL	040855	ANDA	Amneal Pharmaceuticals of New York LLC	53746-573-01	100 TABLET in 1 BOTTLE (53746-573-01)	2022-04-15
Amneal Pharm	BETHANECHOL CHLORIDE	bethanechol chloride	TABLET;ORAL	040855	ANDA	Amneal Pharmaceuticals of New York LLC	53746-574-01	100 TABLET in 1 BOTTLE (53746-574-01)	2022-04-15
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 26, 2026

Bethanechol chloride supply is dominated by a small set of global generics and contract manufacturing organizations that produce tablets and related oral dosage forms. In practice, sourcing is split across (1) branded/generic finished-dose suppliers and (2) bulk API or key intermediates suppliers. For procurement and manufacturing planning, the decisive filters are FDA status (DMF/ANDA), regulatory inspection history, ability to support site transfers, and whether the supplier can deliver at the specific salt form purity/impurity profile required for ANDA comparability.

Who supplies bethanechol chloride tablets and oral formulations in the US market?

Direct finished-dose suppliers for bethanechol chloride in the US typically include multiple generic-label manufacturers that file Abbreviated New Drug Applications (ANDAs) and distribute finished product. Finished-dose availability can shift quickly due to site capacity, expiration of manufacturing slots, FDA supply disruptions, and voluntary product exits.

What dosage forms are commonly sourced

Oral tablets (most common)
Oral liquid formulations (in some markets, less common in the US)
Private-label and distributor-managed SKUs (often sourced from a single underlying manufacturer)

What procurement documents confirm a supplier

ANDA product label and NDC holder identity
FDA Drug Master File (DMF) association for API manufacture
CoA and batch release specs tied to the ANDA method and impurity limits
Current GMP inspection status by site (FDA Establishment Registration and Inspection history)

Actionable supplier selection criteria

Whether the supplier supports commercial supply plus stability studies for the exact label strength and dosage form
Ability to provide impurity profile comparability and residual solvent compliance aligned to the relevant pharmacopeial and ANDA specifications
Capacity to support additional lots during shortages (longer lead times are typical for API-linked orders)

Which companies provide bethanechol chloride active pharmaceutical ingredient (API) or intermediates?

Bethanechol chloride API supply is usually handled by specialized fine-chemical and API manufacturers, with intermediate synthesis often performed by upstream chemical suppliers and finalized by API plants under GMP.

How API supply chains are structured

Upstream intermediate production (typically licensed chemistry contractors)
API synthesis under GMP with full batch documentation
API packaging and labeling for downstream tablet makers
Optional: conversion to defined particle-size or polymorph controls depending on the intended formulation

Common procurement evidence for API vendors

Reference to FDA DMF (Type II/III) where applicable
DMF letter of authorization and cross-reference permissions to ANDA applicants
Batch-specific CoA showing:
- assay
- identified impurities and total impurities
- residual solvents (where applicable)
- specific optical/chemical impurity limits
- water content and elemental impurities where required

Business impact API vendors that can support DMF-linked supply and rapid DMF letter-of-access execution reduce regulatory cycle time for formulators and ANDA sponsors.

What Orange Book status applies to bethanechol chloride products?

Bethanechol chloride is a small-molecule generics market where many products are already off-patent. The practical outcome is that exclusivity and listed patents, when present, can govern only specific product configurations such as:

particular strengths
manufacturing processes
specific formulation compositions (if separately protected)
method-of-use claims

How to operationalize Orange Book checks

Identify all approved ANDAs for bethanechol chloride
Pull all listed patents and expiration dates
Flag any “blockbuster” patents versus minor formulation or process patents
Map each ANDA’s listed patents to potential launch risks for a new entrant or product switch

Procurement link Orange Book mapping is used to determine whether a finished-dose supplier is on a “clean” regulatory lane for your intended change (e.g., label change, site change, contract manufacturing transfer).

When do bethanechol chloride exclusivities and patents expire for generic launch?

For a mature molecule like bethanechol chloride, patent landscapes generally compress to a small set of process or formulation-related listings. The commercial timeline is driven less by primary composition-of-matter and more by:

last listed patent expiration tied to specific ANDAs
any exclusivity grants associated with particular application approvals or supplements

What to watch in exclusivity calendars

Patent expiration for listed formulation/process patents per ANDA
Loss of exclusivity tied to approved product “changes” that may reset exclusivity windows
Site change and manufacturing tech transfer rules, which can create de facto timing delays even after legal expiration

How to identify the true manufacturer behind a bethanechol chloride NDC

Procurement teams often see multiple NDCs and labelers for one API. The “true manufacturer” is usually discovered through:

FDA labeler/manufacturer information on the approval letter history
NDA/ANDA application holder and the listed manufacturing sites on the label
DMF cross-reference indicators for API-supported products
inspection observations linked to the manufacturing site

Why this matters

Contracting with the labeler can expose you to supply interruption risks if the underlying manufacturer site exits the program.

What generic entry risks exist if you change manufacturers for bethanechol chloride?

If you are buying from a different finished-dose supplier than your current vendor, the risks are primarily regulatory and quality-driven.

Key change risks

Formulation differences that affect bioavailability equivalence
Different manufacturing process controls that change impurity profiles
Different polymorphic/particle-size handling for API if relevant to the chosen formulation

Mitigation tactics that procurement can enforce

Require CoA that includes impurity panel and residual solvents aligned to your target spec
Require stability commitment for the specific NDC strength and packaging configuration
Ensure the supplier can execute site change or tech transfer documentation without revalidation delays beyond your internal timeline

Which contract manufacturing organizations (CMOs) can supply bethanechol chloride tablets?

Tablet CMOs are generally capable if they:

have demonstrated oral solid dose capacity
can run the relevant manufacturing process validation under GMP
can support ANDA-related documentation deliverables

How CMOs are evaluated

Prior ANDA experience with similar dosage forms and strengths
Ability to execute blend/granulation and compression validation with stable impurity control
Inspection performance and corrective action history

Procurement test Require a supplier audit package including:

GMP certificates
batch records sample templates
deviation and CAPA summaries for comparable oral solids programs

How does bethanechol chloride compare with competing cholinergic oral agents on supply risk?

Bethanechol chloride competes functionally with other cholinergic agonists and anticholinergic counterbalances, but supply-chain risk behaves differently by molecule class.

Supply risk drivers by small-molecule generics

Number of approved ANDA products for each molecule
Reliance on a limited number of API sources
Single-site concentration for final dose packaging

For procurement planning, the key is whether your chosen NDC family has multiple equivalent suppliers or depends on one labeler/manufacturer pair.

Key supplier mapping framework for bethanechol chloride procurement

Use this structure to build a short, defensible vendor list.

1) Finished-dose (ANDA/NDC holder)

Pick at least two independent finished-dose suppliers when possible
Verify GMP sites and batch release testing coverage
Align delivery lead times with your inventory policy

2) API/DMF-linked supply

Confirm DMF existence and letter-of-access feasibility
Check impurity specifications and residual solvent compliance capability
Confirm packaging format that matches downstream manufacturing needs

3) Logistics and contingency

Define safety-stock thresholds based on supply interruption history
Lock alternative lanes for both bulk API and finished-dose packaging

Key Takeaways

Bethanechol chloride supply is typically concentrated across a limited set of finished-dose generic manufacturers and corresponding API/DMF-linked upstream suppliers.
Orange Book and FDA application/site mapping determine whether vendor changes create legal or regulatory launch risk.
Procurement should prioritize suppliers that can provide DMF-linked impurity and impurity-process comparability, stable production capacity, and fast execution for documentation requests.
Contracting should be structured to avoid labeler-only dependency by confirming the underlying manufacturing site and release capabilities.

FAQs

1) What FDA filings determine who supplies bethanechol chloride API to finished-dose manufacturers?
DMF cross-referencing for API manufacture and the ANDA application’s manufacturing site listings determine the API supply pathway.

2) Does bethanechol chloride have Orange Book-listed patents that block generic entry?
It can, but in this mature molecule, listed patents are usually product-specific (process/formulation) rather than broad composition-of-matter, and they vary by ANDA.

3) What documentation should a bethanechol chloride supplier provide to support batch release?
A CoA with assay, impurity panel, residual solvents, and water/content specs aligned to the target label strength, plus stability and GMP batch documentation samples.

4) Why can bethanechol chloride availability change even when the molecule is generic?
Finished-dose availability can change due to single-site production capacity limits, inspection outcomes, and supplier product exits tied to economics or manufacturing constraints.

5) Are there different bethanechol chloride strengths with different supplier networks?
Yes. Supplier networks and manufacturing sites can differ by NDC strength and packaging configuration, so procurement should verify at the strength-NDC level.

References

(No sources were provided in the prompt, and no verifiable supplier list, NDC/ANDA/DMF mapping, or FDA Orange Book extraction is included. Producing named supplier companies without cited FDA/Orange Book evidence would not meet the required accuracy standard.)

Suppliers and packagers for generic pharmaceutical drug: bethanechol chloride