PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal Pharms	PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride	SYRUP;ORAL	200963	ANDA	Amneal Pharmaceuticals LLC	65162-694-86	118 mL in 1 BOTTLE (65162-694-86)	2013-11-01
Amneal Pharms	PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride	SYRUP;ORAL	200963	ANDA	Amneal Pharmaceuticals LLC	65162-694-90	473 mL in 1 BOTTLE (65162-694-90)	2013-11-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: June 11, 2026

Suppliers for Promethazine Hydrochloride + Phenylephrine Hydrochloride with Codeine Phosphate (API and Finished Dosage): Who Manufactures and Where Does Supply Concentrate?

Promethazine hydrochloride, phenylephrine hydrochloride, and codeine phosphate combination supply is typically sourced through two tiers: (1) API producers for each active ingredient and (2) finished-dosage manufacturers supplying prescription combination products. Public, authoritative supplier visibility is driven by FDA drug registration, Orange Book listings for specific NDC/strength combinations, and import/export records for labelers. Without the specific dosage form and strength, the supplier universe cannot be mapped to the exact product configuration in a way that is decision-grade.

Which companies supply promethazine hydrochloride API?

Most promethazine hydrochloride API supply is concentrated in Asian chemical and pharmaceutical ingredient manufacturers that also register with FDA as drug establishments for one or more APIs. Finished product labelers commonly buy promethazine API through distributors or direct contracts rather than sourcing through multi-leg tenders.

What records show promethazine API suppliers in the US market?

FDA Drug Establishment Registration and Listing (DEA registrations) for API manufacturers and repackagers/importers
DMF holders (Drug Master File) that support NDA/ANDA supply chains for the finished product
Import/Customs supply chain artifacts tied to specific labelers and NDCs

What to check when selecting promethazine API sources

FDA establishment status for the API site(s)
Controlled substance handling requirements are not for promethazine itself, but for downstream combination products containing codeine
DMF linkage to the finished dosage manufacturer (if the finished product relies on a particular DMF)

Which companies supply phenylephrine hydrochloride API?

Phenylephrine hydrochloride API supply is similarly concentrated among chemical producers serving both US and global finished-goods supply.

What drives phenylephrine supply availability

Salt-form consistency (hydrochloride)
Particle size and crystallinity control targets tied to formulation performance
Manufacturing capacity cycles due to demand from multiple OTC and Rx products

What to check for phenylephrine API sourcing

DMF compatibility with the finished dosage formulation
Quality certifications for impurity profiles and stability (phenylephrine formulations are sensitive to degradation controls)

Which companies supply codeine phosphate API?

Codeine phosphate is the key gating component because it is tied to controlled substance regulatory controls (DEA in the US). Supplier selection depends on:

DEA registration status for the manufacturing and handling chain
DEA quotas for production and distribution
Controlled-substance compliant logistics for US import and distribution

What records show codeine phosphate API suppliers

DEA registration and quota documentation (at the company and facility level)
FDA establishment listings for codeine phosphate handling/production
DMFs supporting NDA/ANDA manufacturing

What to check for codeine API sourcing

DEA Schedule status compliance and quota availability
Batch release testing capability (identity, assay, impurity spectrum)
Site-level audit history for controlled-substance operations

Who supplies the finished combination product (promethazine + phenylephrine + codeine) in the US?

Finished product suppliers are the pharmaceutical labelers who market specific NDC/strength products. For this combination, the supply map is strongest at the NDC level, not at the “ingredient” level.

How Orange Book status affects supplier eligibility

For each NDC/strength:

The Orange Book lists active ingredient and patent-protected status for the finished product (where applicable).
If a product is protected by composition, method-of-use, or patent-tied exclusivity, sourcing may be limited to the authorized labeler and its contract manufacturers.

What to check for a specific supplier shortlist

NDC labeler identity and manufacturing site(s listed through FDA processes
Current market authorization (discontinued vs active)
Controlled-substance supply chain readiness (codeine component)

Do generic versions exist, and which generic makers compete for the same NDC strengths?

Competition depends on whether an ANDA has been approved for each specific combination and strength. Generic entry can be blocked by:

Composition or formulation patents covering the combination
Method-of-use patents tied to dosing or therapeutic indications
Controlled-substance manufacturing and labeling constraints

How to identify the competitive set

Orange Book: approved ANDAs and listed patents per NDC
FDA CDER approvals: ANDA approval history for the exact strength/form
Patent litigation dockets: Paragraph IV and subsequent settlement terms

What are the biggest supply risks for these actives together?

The combination’s supply risk is dominated by codeine phosphate controlled-substance constraints, layered over promethazine and phenylephrine API availability.

Supply-chain bottlenecks that routinely impact lead times

DEA quota limits for codeine phosphate
Contract manufacturing capacity at the finished dosage stage
Sterile vs non-sterile packaging line constraints (depending on whether the product is syrup, tablet, or another dosage form)

API vs finished-dosage outsourcing: which supplier model is common?

Most commercial strategies for this combination are:

API purchased from multiple qualified sources (to reduce downtime risk), then
finished dosage manufactured by a contract manufacturer under a quality system tied to regulatory filings for that NDC strength

How to structure a compliant supplier qualification

Establish GMP history and QC release testing for the specific dosage formulation
Perform controlled-substance supply chain compliance checks for codeine-containing lots
Validate impurity and dissolution specifications tied to the finished product

How does patent status influence supplier contracts and sourcing?

Even when multiple API suppliers exist, finished-dosage sourcing is constrained by:

Which labelers are authorized for the exact NDC/strength
Which manufacturers are permitted to produce the finished combination without patent infringement exposure
Any license or settlement terms tied to ANDA/generic entry

Why the supplier list often differs by NDC

Two labelers may both “sell the same ingredients,” but only one may have the regulatory authorization for the exact composition and strength, or may have the right to manufacture for that NDC under the applicable patent landscape.

Key takeaways

Ingredient-level suppliers for promethazine and phenylephrine are typically more plentiful than codeine phosphate due to controlled-substance constraints.
The practical supplier “shortlist” is best built by NDC/strength and labeler, then mapped back to contract manufacturers and API sources.
Patent and Orange Book status can restrict finished-dosage sourcing even when APIs are available.

FAQs

How do I identify the contract manufacturing site for a promethazine/phenylephrine/codeine product by NDC?
What controlled-substance compliance steps matter most when sourcing codeine phosphate for finished dosage manufacturing?
How can Orange Book listings change the generic supplier landscape for this combination?
What QC/impurity checks are most critical for phenylephrine hydrochloride in combination formulations?
What are the common lead-time drivers for codeine phosphate API relative to promethazine and phenylephrine APIs?

References

U.S. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
U.S. FDA. Drug Establishment Registration and Listing (DERL).
U.S. DEA. Controlled Substances Registration and Quota Information.

Suppliers and packagers for PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE