Last Updated: May 10, 2026

Suppliers and packagers for generic pharmaceutical drug: PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE


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PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE 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
Genus PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 040654 ANDA Genus Lifesciences Inc. 64950-345-16 473 mL in 1 BOTTLE, PLASTIC (64950-345-16) 2024-07-15
Amneal Pharms PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 040902 ANDA Amneal Pharmaceuticals LLC 65162-679-86 118 mL in 1 BOTTLE (65162-679-86) 2009-08-25
Amneal Pharms PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 040902 ANDA Amneal Pharmaceuticals LLC 65162-679-90 473 mL in 1 BOTTLE (65162-679-90) 2009-08-25
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for Phenylephrine Hydrochloride and Promethazine Hydrochloride

Last updated: April 23, 2026

Which suppliers make phenylephrine hydrochloride (API)?

Phenylephrine hydrochloride (API) supply is concentrated among global chemical and pharmaceutical ingredient producers. Commonly sourced suppliers include:

  • Merck KGaA / MilliporeSigma (phenylephrine hydrochloride; analytical and bulk supply lines)
  • TCI Chemicals (phenylephrine hydrochloride; bulk and reagent supply)
  • Thermo Fisher Scientific (phenylephrine hydrochloride via catalog and distribution)
  • Alfa Aesar / Thermo Fisher (phenylephrine hydrochloride)
  • Hangzhou Keying Biotechnology (phenylephrine hydrochloride; commercial API availability in multiple grades)
  • Mitsui Chemicals / specialty chemical supply networks (phenylephrine hydrochloride intermediates and downstream sourcing channels)
  • Gedeon Richter / domestic manufacturer networks (EU sourcing channels) (phenylephrine-related ingredient sourcing through regional partners)

Documented use in marketed products: Phenylephrine hydrochloride is used in oral, nasal, and injectable formulations and is widely traded as an API and as a pharmaceutical-grade ingredient in dosage forms (OTC and hospital). This drives multi-path procurement through catalog suppliers and GxP intermediates distributors.

Which suppliers make promethazine hydrochloride (API)?

Promethazine hydrochloride (API) supply is similarly concentrated across global API and specialty chemical networks. Commonly sourced suppliers include:

  • Merck KGaA / MilliporeSigma (promethazine hydrochloride; bulk and analytical grades)
  • TCI Chemicals (promethazine hydrochloride; bulk and reagent supply)
  • Thermo Fisher Scientific (promethazine hydrochloride via catalog and distribution)
  • Alfa Aesar / Thermo Fisher (promethazine hydrochloride)
  • Hangzhou Keying Biotechnology (promethazine hydrochloride; commercial API availability in multiple grades)
  • Jiangsu Hengrui and regional Chinese API suppliers (promethazine hydrochloride via commercial API channels)
  • Aurobindo/Dr. Reddy’s supply chains (regional sourcing) (promethazine hydrochloride availability through formulation manufacturing procurement networks)

Documented use in marketed products: Promethazine hydrochloride is used in antiemetic, antihistamine, and motion sickness formulations and is widely traded in multiple salt grades (hydrochloride). It is also sourced through generic formulation supply chains, which tends to expand the supplier set for API and for intermediate salt forms.


What supplier categories exist for these two APIs?

1) Catalog chemical suppliers (quick procurement)

Typical buyers include formulation labs and low-volume manufacturers that source API for development and small production runs. Examples:

  • MilliporeSigma (Merck)
  • TCI
  • Thermo Fisher / Alfa Aesar

2) Commercial API manufacturers (GMP/DMF supply)

These suppliers support scale-up and marketed manufacturing, with audit and documentation packages (GMP certificates, COAs, impurity specs). Examples based on market listings:

  • Chinese API and chemical manufacturers such as Hangzhou-based producers and other regional API makers.

3) Pharmaceutical ingredient distributors (multi-brand coverage)

Distributors help buyers standardize procurement and manage stock. They usually bundle multiple manufacturers under one ordering channel (faster lead times, consolidated documentation workflow).


How do buyers validate the “right” supplier for API-grade material?

Procurement in this category typically hinges on:

  • Grade: USP/EP/BP-comparable or “pharmaceutical grade” packaging and spec sheet
  • GMP status: manufacturer or packager with appropriate GMP certification
  • Documentation: CoA/CoC, impurity profile, residual solvents where relevant, and traceability
  • Consistency: polymorph/hydrate behavior controls for solids and salt identity confirmation
  • Regulatory readiness: ability to support DMF/ASMF-style dossiers for global customers

Side-by-side procurement reality

API Typical procurement paths Where suppliers concentrate
Phenylephrine hydrochloride Catalog chemical suppliers, commercial API makers, distributors Broad global chemical catalog ecosystem and China-based API supply
Promethazine hydrochloride Catalog chemical suppliers, commercial API makers, formulation supply chains via distributors Broad global catalog plus commercial generics supply network

Key Takeaways

  • Phenylephrine hydrochloride and promethazine hydrochloride are both widely stocked across major chemical catalog suppliers and commercial API makers, with additional coverage through pharmaceutical ingredient distributors.
  • For development or low-volume sourcing, MilliporeSigma, TCI, and Thermo Fisher/Alfa Aesar are recurring procurement entry points.
  • For manufacturing-scale procurement, buyers typically shift to commercial API manufacturers (including China-based API producers) that can provide GMP and impurity-spec documentation.

FAQs

1) Do MilliporeSigma, TCI, and Thermo Fisher supply both APIs?

Yes. Each typically supplies phenylephrine hydrochloride and promethazine hydrochloride through catalog and distribution channels.

2) Are these APIs patent-protected in a way that restricts supplier choice?

These ingredients are generic small-molecule APIs with broad supplier availability in commercial supply chains.

3) What supplier type is best for manufacturing-grade supply?

Commercial API manufacturers that can provide GMP documentation and impurity/solvent specs aligned to customer requirements.

4) Is distributor procurement common for these APIs?

Yes. Distributors consolidate manufacturer sources and manage lead time and documentation workflows.

5) What determines whether a supplier is acceptable for regulated use?

GMP certification, CoA consistency, impurity profile control, and the ability to support documentation packages suitable for the buyer’s regulatory pathway.


References

[1] Merck KGaA. MilliporeSigma Product Catalog: Phenylephrine hydrochloride.
[2] Merck KGaA. MilliporeSigma Product Catalog: Promethazine hydrochloride.
[3] TCI Chemicals. Product information pages: Phenylephrine hydrochloride.
[4] TCI Chemicals. Product information pages: Promethazine hydrochloride.
[5] Thermo Fisher Scientific. Product pages and catalog listings: Phenylephrine hydrochloride.
[6] Thermo Fisher Scientific. Product pages and catalog listings: Promethazine hydrochloride.

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