CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mainpointe	TUXARIN ER	chlorpheniramine maleate; codeine phosphate	TABLET, EXTENDED RELEASE;ORAL	206323	NDA	Mainpointe Pharmaceuticals	71269-040-10	100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71269-040-10)	2018-10-15
Mainpointe	TUXARIN ER	chlorpheniramine maleate; codeine phosphate	TABLET, EXTENDED RELEASE;ORAL	206323	NDA	Mainpointe Pharmaceuticals	71269-040-30	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71269-040-30)	2018-10-15
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 28, 2026

Chlorpheniramine maleate and codeine phosphate are typically sourced through three supplier layers: API manufacturers for the active ingredients, salt/intermediate suppliers that provide the maleate and phosphate forms, and finished-dosage manufacturers that buy API and ship drug product. Below is a supplier map for the active ingredients and the most common sourcing routes used by pharmaceutical buyers.

Who manufactures chlorpheniramine maleate API and related intermediates?

Chlorpheniramine maleate is an older antihistamine API that is manufactured globally. Buyers usually source either:

chlorpheniramine base then convert to the maleate salt, or
chlorpheniramine maleate directly as an isolated API.

Chlorpheniramine maleate API: common supplier profile

Most suppliers offer:

chlorpheniramine maleate API in standard compendial strengths,
milling/granulation services for dosage-form compatibility,
and documentation packages aligned to DMF/CEP expectations where available.

Representative chlorpheniramine maleate API and salt suppliers (global)

Hovid Bhd / Hovid Pharma (UK/Malaysia-origin supply chain entities): supplies for antihistamine product ecosystems.
MacChem (India): provides API and intermediate sourcing for controlled and non-controlled legacy drugs where permitted by local compliance.
Aceto Corporation (US): distributes legacy APIs and salts via brokered or direct relationships for small and midsize formulators.
BASF / Merck (legacy chains via distributors): often participate indirectly through distribution of stocked APIs or historical product lines, with actual API manufacture typically via specialized chemical suppliers.

How chlorpheniramine maleate is commonly sourced

Direct API purchase (preferred by dosage-form firms).
Salt-formation outsourcing using chlorpheniramine base and maleic acid intermediates.
Brokered fulfillment for low-volume buyers and fast lead times.

Sourcing checkpoints used by buyers

DMF/CEP status for the API.
Particle size distribution and polymorph/salt form controls for consistency in oral solids.
Residual solvents, heavy metals, and impurity profiles matching pharmacopeial and local requirements.

Who manufactures codeine phosphate API and codeine base intermediates?

Codeine phosphate is an opioid API. Supply is constrained by national opioid-licensing regimes and global quota frameworks that govern manufacture, trade, and possession.

Codeine phosphate API: common supplier profile

Suppliers typically offer:

codeine phosphate API with structured impurity specs,
supply-chain transparency for DEA controlled substance handling (US) or equivalent oversight elsewhere,
and lot-level documentation required by regulated distributors.

Representative codeine phosphate API and intermediates suppliers (global)

Boehringer Ingelheim / Janssen supply chains (EU): codeine phosphate is commonly handled through licensed pharmaceutical supply chains in Europe via specialized API producers.
Mallinckrodt (Opioid/controlled substances ecosystem): participates in controlled-substance manufacturing and supply infrastructure.
Pfizer controlled-substance supply network (EU/US routes via licensed channels).
Local national codeine/pharmaceutical alkaloid processors in major producing regions (frequently with contracts tied to licensing and quotas).

How codeine phosphate is commonly sourced

Direct purchase from a licensed API manufacturer where quotas and trafficking permissions are in place.
Brokered distribution through DEA-licensed or equivalent entities for customers without direct API manufacturing relationships.
Intermediates-first sourcing (codeine base followed by phosphate salt formation), used when API salt-form standardization is easier through controlled salt-formation steps.

Sourcing checkpoints used by buyers

Evidence of controlled-substance licensure at each supply-chain node.
Lot traceability and batch record availability.
Compliance alignment with destination country controlled-substance regulations.

Which companies can supply both chlorpheniramine maleate and codeine phosphate for combination products?

Combination cough/cold and allergy formulations that include an antihistamine plus an opioid antitussive drive demand for suppliers that can support mixed API procurement under one regulatory purchasing workflow.

Two sourcing patterns

Separate API sourcing from antihistamine API manufacturers and separate controlled-substance suppliers for codeine phosphate.
One-stop purchasing via a distributor that consolidates APIs and handles controlled substance distribution separately.

Common “one-stop” supplier categories

International API distributors (handle chlorpheniramine maleate directly; route codeine phosphate through licensed controlled-substance logistics).
CMOs with sourcing operations that purchase APIs under their own regulatory and controlled-substance licenses and provide the drug product in finished form.

What are the typical raw-material and intermediate inputs suppliers provide?

For chlorpheniramine maleate

chlorpheniramine base (or upstream chlorpheniramine intermediates),
maleic acid for salt formation,
and process intermediates from established antihistamine manufacturing routes.

For codeine phosphate

controlled codeine base or opiate alkaloid intermediates,
phosphoric acid (for salt formation when the supplier does not isolate phosphate directly),
and regulated solvent/utilities consistent with controlled-substance API manufacturing.

How does supplier qualification work for chlorpheniramine maleate and codeine phosphate APIs?

Documentation buyers expect

Manufacturer and site details (including all subcontractors).
GMP certificates and inspection history.
DMF or CEP where applicable.
Certificate of Analysis and CoO at batch level.
Impurity profile and residual solvent compliance.

Controlled-substance-specific diligence for codeine phosphate

Verified licensing to manufacture, hold, and ship.
Chain-of-custody records and traceability.
Destination-country controlled substance clearance.

What pricing and lead-time dynamics affect API sourcing for these actives?

Chlorpheniramine maleate

Price depends primarily on global legacy antihistamine API production capacity, batch size, and documentation tiering (CEP/DMF support).
Lead times are typically shorter than opioids where supply is more diversified.

Codeine phosphate

Price and lead time depend on controlled-substance quota allocations, licensed manufacturing availability, and destination controlled-substance logistics.
Spot shortages are more likely when quotas tighten.

How should buyers structure dual-sourcing strategies for these APIs?

Recommended sourcing structure

Two chlorpheniramine maleate suppliers with different manufacturing sites to reduce supply disruption and improve audit coverage.
Two codeine phosphate suppliers with independently licensed controlled-substance fulfillment paths.

Contracting clauses commonly used

supply commitments by quarter,
batch acceptance criteria tied to impurity specs,
documentation delivery SLAs (DMF amendments, CoA timelines),
and change control triggers (process changes, supplier site changes, salt form control).

Key Takeaways

Chlorpheniramine maleate is typically sourced through a broader set of global antihistamine API and salt-form suppliers; buyers often choose direct API purchase or salt formation from chlorpheniramine base.
Codeine phosphate is constrained by controlled-substance manufacturing, quota, and licensure frameworks; buyers require controlled chain-of-custody and licensed distribution at every step.
For combination products, buyers commonly use either separate API sourcing plus controlled logistics for codeine, or consolidation through distributors/CMOs that can handle controlled-substance compliance.

FAQs

Which suppliers are best for chlorpheniramine maleate API in standard dosage-form grades?

Typically, buyers select manufacturers or distributors with demonstrated DMF/CEP support, stable impurity profiles, and oral-solid compatibility (particle size control, polymorph/salt form consistency).

Who can supply codeine phosphate API for regulated markets like the US and EU?

Only suppliers and distributors with the required national controlled-substance licenses and quota-compatible supply chains can reliably supply codeine phosphate for regulated markets.

Can chlorpheniramine maleate be sourced via chlorpheniramine base salt formation?

Yes. Many formulators source chlorpheniramine base and contract salt formation to maleate, using maleic acid and validated crystallization controls to match the target salt form.

What documents are critical when onboarding new API suppliers for these actives?

For both: GMP certificate, CoA, impurity profile, residual solvents/heavy metals compliance, and audit-ready quality agreements. For codeine: controlled-substance licenses and full traceability documentation.

What supply-chain risks are most relevant for codeine phosphate?

Quota allocation, licensing constraints, and controlled-substance logistics delays typically drive availability risk more than batch-to-batch technical variability.

References

FDA. “Drug Master File (DMF) Program.” U.S. Food and Drug Administration.
EMA. “CEP and Quality Documentation for Human Medicinal Products.” European Medicines Agency.
UNODC. “International Narcotics Control Board (INCB) controlled substances framework resources.” United Nations Office on Drugs and Crime.
ICH. “Quality Guidelines for APIs and Impurities (Q-series) and Pharmaceutical Development (Q8/Q9/Q10).” International Council for Harmonisation.

Suppliers and packagers for generic pharmaceutical drug: CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE

CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE

Suppliers for Chlorpheniramine Maleate and Codeine Phosphate: Active Pharmaceutical Ingredient Manufacturers, Key Raw-Material Sources, and Sourcing Routes