Suppliers and packagers for PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE

PHENYLEPHRINE HYDROCHLORIDE AND 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
Pai Holdings	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

Suppliers for Phenylephrine Hydrochloride and Promethazine Hydrochloride (APIs and Finished Dosage Forms): Who Can Supply, How They’re Positioned, and What to Validate

Last updated: May 31, 2026

Executive summary: Phenylephrine hydrochloride and promethazine hydrochloride are widely sourced, with supply typically split between API manufacturers and contract manufacturing organizations (CMOs) that produce finished dosage forms (tablets, syrups, injectables). Market access for new entrants is driven less by “who makes the chemical” and more by supply chain compliance (DMF/CEP status, GMP history, regulatory filings), packaging formats, and controllable impurities. The highest practical risk points for procurement are batch-to-batch impurity profiles, salt-form consistency, and the stability of finished formulations where phenylephrine hydrochloride is light/oxidation sensitive and dosing uniformity matters.

What companies supply phenylephrine hydrochloride API in the US and EU?

Which supplier types exist for phenylephrine hydrochloride

Procurement typically comes from three channels:

• API producers that file a US DMF and supply to multiple customers.
• Intermediate and fine-chemical suppliers that deliver phenylephrine hydrochloride under a customer’s specifications (often via tolling).
• CMOs that integrate API sourcing and produce finished dosage forms, then supply branded or relabeled products.

Key supplier validation items for phenylephrine hydrochloride

For tendering or qualification, the most decision-relevant checks usually include:

• DMF status and letter-of-access feasibility for your application.
• GMP status for the manufacturing site (FDA inspection outcome history and EU GMP certificates).
• Test method equivalence for key release assays (assay, related substances, residual solvents, water content).
• Impurity controls specific to phenylephrine hydrochloride routes, including oxidation-related impurities and process-byproducts (verified against your reference standard).

Regulatory documentation to require

• DMF (Type II/III) referenced to your intended dossier type.
• CoA for recent lots with full related substances panel.
• Stability protocol data aligned to your intended shelf life and storage conditions.

What companies supply promethazine hydrochloride API in the US and EU?

Supplier characteristics for promethazine hydrochloride

Promethazine hydrochloride is commonly available at scale, but supplier differentiation comes from:

• Consistent impurity profile control across routes.
• Ability to support sterile or injectable finished dosage manufacturing (if you need injectable promethazine).
• Experience with scale-up and maintaining polymorph and particle characteristics that affect dissolution and content uniformity.

Procurement checks that matter for promethazine hydrochloride

• Related substances profile and any route-specific impurities.
• Particle size distribution and bulk density for solid oral forms.
• Solvent/residual limits aligned to your target compendial or specification set.

Regulatory documentation to require

• DMF linkage and documentation for your dosage form type.
• Batch manufacturing record summary for deviations tied to impurity excursions.
• Sterility assurance package if supplying injectable finished forms through a CMO.

Are there licensed distributors or “authorized suppliers” for these APIs?

Distributor vs. manufacturer sourcing

In practice, many buyers use:

• Authorized distributors that maintain chain-of-custody documentation, or
• Direct manufacturer sourcing through purchase agreements tied to DMF access and quality agreements.

Qualification barriers

Even when distributors carry stock, qualification still hinges on:

• Ability to provide right-to-sell documentation tied to your regulatory filing needs.
• GMP and traceability documentation per shipment.
• Consistency of supplied grade (USP/NF, EP, BP, or internal specs).

Which suppliers can provide finished dosage forms containing phenylephrine HCl and promethazine HCl?

Common finished dosage form formats

• Oral tablets (combination products in some markets).
• Oral syrups/solutions where both actives are dosed for symptomatic treatment.
• Injectables for promethazine HCl use where APIs are sterile-manufactured via qualified sterile processes (phenylephrine injectable combinations depend on product history and approvals).

CMO criteria

When selecting a CMO for finished product manufacturing, procurement typically targets:

• Formulation capability for both APIs in the same product line.
• Experience with combination stability (phenylephrine oxidation and promethazine stability under your target pH and excipient system).
• Packaging system compatibility (light protection, moisture barrier, closure selection).

What API grade specifications should suppliers meet for phenylephrine HCl and promethazine HCl?

Common specification framework

Most bidders align to one of these:

• USP/NF-compliant internal COA panels
• Ph. Eur./BP aligned panels
• Internal tighter specifications tied to your regulatory dossier

Must-have analytical panels

• Assay
• Loss on drying or water content (as applicable)
• Related substances (full panel)
• Residual solvents (ICH Q3C framework)
• Heavy metals (if required by your spec set)
• Particle size (often for oral solid dosage forms)

When do these drugs lose exclusivity, and does that affect supplier selection?

Exclusivity effect is indirect for API procurement

If your scope is API or CMO sourcing, exclusivity timelines mainly affect:

• Pricing power and volume forecasts for manufacturers.
• Availability of finished product supply contracts.
• Likelihood of generic or relabeled competition that expands purchase options.

What procurement should monitor

• Product lifecycle status for any combination finished dosage form you intend to manufacture.
• Whether suppliers are currently supporting a branded market, generic market, or both.

What patent risks affect sourcing or contract manufacturing of combination products?

IP exposure flows from the finished product

For combination products containing both phenylephrine HCl and promethazine HCl, patent risk generally follows:

• Formulation patents (fixed-dose ratios, excipients, manufacturing process)
• Method-of-use patents (indications, dosing regimens)
• Packaging and stability claims in some jurisdictions

How to de-risk procurement

• Require suppliers/CMOs to provide representations tied to freedom-to-operate support for the manufacturing process they will run.
• Ensure the intended dosage form route does not require an IP-licensed step you cannot access.

How to screen phenylephrine HCl and promethazine HCl suppliers for quality and supply assurance

Supplier due diligence checklist

• GMP compliance at the site that makes your specific grade.
• DMF or regulatory dossier alignment with your target markets.
• Change control maturity: notifications for process or impurity changes.
• Analytical capability: validated methods and reference standards management.
• Stability support: data for intended packaging and storage.

Contracting points that prevent supply disruptions

• Lead time and safety stock commitments.
• Audit rights and quality agreement terms.
• Alert and remediation timeline for OOS/OOT events.
• Agreement on investigation ownership for root cause.

Which regions tend to be strongest for supplying these APIs?

Typical supply geography

• China and India are common API source geographies for these well-established actives, often with multiple DMF-supported manufacturers.
• Europe tends to be strong where suppliers support CEP/DMF frameworks and tighter EU-centric compliance models.
• US domestic supply exists at smaller scale for specific grades and for certain finished dosage form needs via CMOs.

What to validate by region

• Evidence of GMP history that matches your compliance requirements.
• Documented impurity profiles against your desired specs.
• Responsiveness and audit readiness.

Key Takeaways

• Supplier selection for phenylephrine hydrochloride and promethazine hydrochloride is primarily driven by regulatory documentation alignment (DMF access and GMP status), impurity control consistency, and finished dosage-form stability capability if you need combination products.
• For API procurement, the highest risk points are related substances consistency, residual solvent/water controls, and stability-linked impurity growth depending on storage and packaging.
• For finished dosage forms, supplier differentiation shifts to combination formulation capability, sterile/non-sterile manufacturing readiness, and proven packaging compatibility.

FAQs

1. What documentation should I require from an API supplier for phenylephrine hydrochloride to support an FDA filing?
2. Do promethazine hydrochloride impurity profiles differ significantly by manufacturing route, and how should that be handled contractually?
3. What packaging considerations matter most for phenylephrine hydrochloride stability in finished oral products?
4. How do DMF letter-of-access and site change notifications impact the ability to qualify new suppliers?
5. What due diligence steps best predict ongoing supply reliability for combination products containing phenylephrine HCl and promethazine HCl?

References

1. FDA. Drug Master Files (DMFs). (FDA.gov).
2. ICH. ICH Q3C: Impurities: Residual Solvents. (International Council for Harmonisation).
3. ICH. ICH Q1A: Stability Testing of New Drug Substances and Products. (International Council for Harmonisation).