Last Updated: May 11, 2026

Suppliers and packagers for generic pharmaceutical drug: TRIMETHOBENZAMIDE HYDROCHLORIDE


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TRIMETHOBENZAMIDE HYDROCHLORIDE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Heritage Pharma Avet TRIMETHOBENZAMIDE HYDROCHLORIDE trimethobenzamide hydrochloride CAPSULE;ORAL 205950 ANDA Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 23155-180-01 100 CAPSULE in 1 BOTTLE (23155-180-01) 2023-11-21
Heritage Pharma Avet TRIMETHOBENZAMIDE HYDROCHLORIDE trimethobenzamide hydrochloride CAPSULE;ORAL 205950 ANDA Chartwell RX, LLC 62135-773-30 30 CAPSULE in 1 PACKAGE (62135-773-30) 2023-11-21
Heritage Pharma Avet TRIMETHOBENZAMIDE HYDROCHLORIDE trimethobenzamide hydrochloride CAPSULE;ORAL 205950 ANDA Chartwell RX, LLC 62135-773-90 90 CAPSULE in 1 PACKAGE (62135-773-90) 2023-11-21
Lupin TRIMETHOBENZAMIDE HYDROCHLORIDE trimethobenzamide hydrochloride CAPSULE;ORAL 076546 ANDA Lupin Pharmaceuticals,Inc. 43386-660-03 30 CAPSULE in 1 BOTTLE (43386-660-03) 2011-01-17
Lupin TRIMETHOBENZAMIDE HYDROCHLORIDE trimethobenzamide hydrochloride CAPSULE;ORAL 076546 ANDA Lupin Pharmaceuticals,Inc. 43386-660-24 100 CAPSULE in 1 BOTTLE (43386-660-24) 2011-01-17
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Who Supplies Trimethobenzamide Hydrochloride to the Market?

Last updated: April 26, 2026

Suppliers for trimethobenzamide hydrochloride show up across three procurement channels: US generics manufacturers, API and intermediate producers, and global pharma distributors/wholesalers. The same substance is also sold under multiple salt and dosage form variants (notably trimethobenzamide hydrochloride, often described as “trimethobenzamide HCl”), so procurement lists should be matched by CAS identifiers and salt form rather than by brand name.

What reference identifiers anchor procurement for trimethobenzamide hydrochloride?

Use these identifiers when mapping suppliers:

Identifier type Value
Salt / form Trimethobenzamide hydrochloride
Common synonym “trimethobenzamide HCl”
Typical description in catalogs “Trimethobenzamide hydrochloride, USP” or “Ph. Eur.” (varies by supplier)

Which companies supply trimethobenzamide hydrochloride (API or finished dosage)?

Below are supplier entities that commonly appear in pharmaceutical supply catalogs and distribution networks for this active ingredient. Supplier availability varies by region, licensing status, and dosage strength.

US finished-dose and generic drug supply (procurement via wholesalers and generic manufacturers)

Procurement typically routes through authorized wholesalers and generic drug channels for finished products containing trimethobenzamide hydrochloride. Active ingredient listings and product registrations are maintained through FDA databases and commercial wholesaler catalogs. (Use FDA drug listings and wholesaler catalogs for exact NDC-to-supplier mapping.)

API and intermediate supply (procurement via API distributors and specialty chemical manufacturers)

API sourcing for trimethobenzamide hydrochloride typically comes from:

  • API manufacturers (producing the hydrochloride salt or producing trimethobenzamide then salting to HCl),
  • chemical producers (intermediate and API),
  • API trading houses (sourcing from multiple plants and supplying to formulators).

International distribution (global wholesalers)

Global pharma distributors commonly carry the salt as:

  • “trimethobenzamide hydrochloride” bulk powder,
  • “trimethobenzamide hydrochloride USP/EP grade” (quality-grade dependent),
  • packaging sizes like 25 g, 100 g, 1 kg, 5 kg, 25 kg (catalog dependent).

Which supplier types matter for R&D vs commercial manufacturing?

Procurement goal Best supplier category What you confirm
Prototype formulation / lab lots API distributors or chemical-grade producers COA, HPLC assay, salt confirmation (HCl), particle spec (if provided)
Pilot/scale-up API manufacturers or qualified contract suppliers GMP/DMF alignment, traceability, impurity profile capability
Commercial manufacturing Qualified API and/or drug product manufacturers Regulatory status (where applicable), supply continuity, change-control history

How to validate supplier equivalence (salt, grade, and regulatory state)?

Trimethobenzamide hydrochloride is sensitive to mismatch in:

  • salt form (HCl vs free base),
  • grade (USP/EP vs non-pharm-grade),
  • spec limits (assay and related substances differ by supplier and grade).

For procurement diligence, validate the following on every supplier COA:

  1. Identity (IR, HPLC retention, or salt confirmation method)
  2. Assay (percent label claim)
  3. Related substances / impurities (HPLC method and acceptance limits)
  4. Water content (Karl Fischer or LOQ-specific method)
  5. Residual solvents (if relevant to supplier process)
  6. Heavy metals (where applicable for pharm-grade)

Where to confirm supply eligibility and registrations

Use the following authoritative registries and databases to tie a supplier to a compliant supply chain:

  • FDA Drug Product listings for finished drug presence and manufacturer/distributor labels.
  • FDA Orange Book for approved generic drug products (where trimethobenzamide hydrochloride is listed as an active ingredient in an approved drug product).
  • FDA NDC Directory for label and listing data associated with distributors and products.

These sources support mapping from “supplier in a catalog” to “supplier with an approved product presence.”

Key supplier mapping framework (actionable for sourcing)

Build a supplier decision file with three layers:

  1. Product layer (finished-dose)

    • NDC-level mapping to distributor and manufacturer
    • confirm label claims, strengths, package types
  2. API layer (bulk)

    • supplier name, plant location (if available)
    • grade (USP/EP vs non-compendial)
    • COA data consistency across lots
  3. Compliance layer

    • GMP status (if claimed)
    • regulatory linkage (DMF or referenced status where applicable)
    • change-control evidence and impurity trend stability

Key Takeaways

  • Trimethobenzamide hydrochloride sourcing typically splits between finished-dose supply (through FDA-listed product channels and authorized wholesalers) and API/bulk supply (through API manufacturers, chemical producers, and API distributors).
  • Procurement must validate salt form (HCl) and grade because trimethobenzamide hydrochloride is commonly sold under “trimethobenzamide HCl” with varying quality specifications.
  • Use FDA drug product registries to tie commercial availability to compliant listings, then use COA-based verification to confirm identity, assay, and impurity controls.

FAQs

1) Is “trimethobenzamide HCl” the same as “trimethobenzamide hydrochloride”?

Yes. “Trimethobenzamide HCl” is a common shorthand for trimethobenzamide hydrochloride; procurement should still confirm salt form on the COA.

2) Do suppliers carry both API and finished-dose products?

Some do for distribution or contract manufacturing networks, but many companies specialize either in API bulk or finished-dose. Confirm what each supplier sells (API, intermediates, or finished drug).

3) What should the buyer verify in the COA for this API?

Identity (salt confirmation), assay, related substances/impurities, water content, residual solvents (if applicable), and heavy metals for pharm-grade products.

4) How do you confirm regulatory linkage in the US?

Map to FDA drug product listings and the NDC Directory for finished products; check the Orange Book for listed approved generics where applicable.

5) Are multiple grades offered for trimethobenzamide hydrochloride?

Yes. Catalogs often differentiate between compendial grades (USP/EP) and non-compendial grades. Specs differ by supplier and should be checked against the intended use.


References (APA)

  1. U.S. Food and Drug Administration. (n.d.). FDA NDC Directory. https://www.fda.gov/drugs/drug-approvals-and-databases/ndc-directory
  2. U.S. Food and Drug Administration. (n.d.). Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
  3. U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.fda.gov/drugs/therapeutic-equivalence-guidance-documents/orange-book-approved-drug-products-therapeutic-equivalence-evaluations

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