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Suppliers and packagers for generic pharmaceutical drug: DEXCHLORPHENIRAMINE MALEATE
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DEXCHLORPHENIRAMINE MALEATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Pharmobedient | POLMON | dexchlorpheniramine maleate | SYRUP;ORAL | 202520 | ANDA | CARWIN PHARMACEUTICAL ASSOCIATES, LLC | 15370-150-04 | 118 mL in 1 BOTTLE, PLASTIC (15370-150-04) | 2018-10-07 |
| Pharmobedient | POLMON | dexchlorpheniramine maleate | SYRUP;ORAL | 202520 | ANDA | CARWIN PHARMACEUTICAL ASSOCIATES, LLC | 15370-150-16 | 473 mL in 1 BOTTLE, PLASTIC (15370-150-16) | 2018-10-07 |
| Pharmobedient | POLMON | dexchlorpheniramine maleate | SYRUP;ORAL | 202520 | ANDA | CARWIN PHARMACEUTICAL ASSOCIATES, LLC | 15370-150-99 | 20 mL in 1 BOTTLE, PLASTIC (15370-150-99) | 2018-10-07 |
| Pharmobedient | POLMON | dexchlorpheniramine maleate | SYRUP;ORAL | 202520 | ANDA | BluCrest Pharmaceuticals LLC | 73684-300-08 | 237 mL in 1 BOTTLE, PLASTIC (73684-300-08) | 2025-10-22 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: DEXCHLORPHENIRAMINE MALEATE
DEXCHLORPHENIRAMINE MALEATE suppliers: key global manufacturers, API sources, and contract options
Executive summary: Dexchlorpheniramine maleate supply is dominated by regional generic manufacturers supplying antihistamine APIs and finished-dose tablets/solutions. In the absence of your target dosage form, buyer geography, and intended regulatory market, the only actionable supplier set is the set of established API and finished-dose producers that publicly commercialize dexchlorpheniramine maleate or tightly related antihistamine lines through global distribution and tolling.
This page compiles the supplier landscape by (1) API producers and (2) finished-dose manufacturing and contract packaging. It also maps practical diligence checkpoints used by procurement, RA, and licensing teams.
Which companies supply dexchlorpheniramine maleate API (raw material)?
Answer: Search and procurement generally treat dexchlorpheniramine maleate as a generic antihistamine API where supply comes from small-to-mid size specialty API manufacturers and broad generic API groups. Most commercially reliable sources publish CoA/DMF-ready documentation via distributors or directly via regulatory affairs teams.
Common API sourcing routes
- API manufacturer direct supply (request API specs, particle size, polymorph if applicable, residual solvents, impurity profile, TSE/BSE statement, and GMP status).
- Authorized distributor supply (faster lead times; higher traceability if distributor is “authorized” for the specific API batch).
- Toll manufacture (if your formulation IP or impurity controls require tighter process matching).
Typical due diligence checkpoints (procurement standard)
- GMP compliance: API site GMP status and inspection history.
- Documentation: batch CoA, impurity report, analytical method capability, stability protocol.
- Regulatory readiness: DMF/CEP availability, letter of access if needed.
- Quality systems: change control, deviations, CAPA cadence, out-of-spec handling.
- Supply continuity: second-source availability and safety stock policy.
Who supplies dexchlorpheniramine maleate finished dosage forms (tablets, syrups, oral solutions)?
Answer: Finished-dose availability depends on country approvals and labeling. Many producers sell as private label under antihistamine and cold/allergy portfolios, with manufacturing in generic oral solid dose and oral liquid lines.
Dosage form split buyers typically face
- Oral tablets/caplets: usually from established oral solid dose (OSD) generic plants.
- Oral syrups/solutions: usually from plants with controlled viscosity blending, microbiology control, and preservative/antimicrobial validation.
Contract manufacturing and contract packaging
If you need speed to market or you are importing finished-dose product:
- Look for contract manufacturing organizations (CMOs) with established antihistamine liquid filling and bottle labeling lines.
- For private label, confirm brand owner compliance (label artwork control, QMS traceability, and batch genealogy).
What distributors sell dexchlorpheniramine maleate internationally?
Answer: Distributors typically route dexchlorpheniramine maleate to buyers through API lines and private label finished product channels. Procurement usually uses distributor sourcing for lead time, while RA teams validate the chain-of-custody, GMP origin, and documentation package.
Distributor diligence checklist
- Authorized status for the specific API grade or dosage form
- Batch traceability documentation
- Ability to provide full CoA package and method cross-walks
- No substitution policy without written change control approval
- Incoterms and cold-chain needs (generally minimal for APIs; confirm for liquid products)
How do supplier lists differ by geography (US, EU, India, China, MENA)?
Answer: Geography changes the supplier set more than the product does.
United States
- Suppliers that can support DMF/letters of access are prioritized for API and for finished-dose import.
- For finished products, procurement typically uses companies with ANDA track record and US-facing quality systems.
European Union
- Supplier qualification emphasizes CEP/DMF alignment, GMP annex compliance, and dossier support under EU timelines.
- Oral solid and liquid plants with broad generic portfolios have more consistent documentation packages.
India and China
- Large generic ecosystems supply both API and finished-dose.
- Buyers typically screen heavily for impurity profile consistency, residual solvents, particle size controls (for solids), and liquid microbial limits.
MENA and LATAM
- Finished-dose private label and distribution networks matter more than API-only procurement.
- Compliance documents and bilingual labeling capabilities drive procurement.
What supplier credentials matter most for dexchlorpheniramine maleate quality?
Answer: For a generic antihistamine API, the highest-value supplier criteria are GMP status, impurity control, and regulatory dossier support.
API critical quality attributes
- Assay and related substances (impurity panel and limits)
- Water/solvent residues (residual solvents, moisture)
- Physical form (maleate salt consistency, polymorph if relevant to the supplier’s control strategy)
- Stability (API shelf-life under ICH storage conditions)
Finished-dose critical quality attributes
- Dose uniformity (tablet content uniformity) or concentration accuracy (liquid)
- Microbial limits (for syrups/solutions)
- Preservative efficacy validation (where applicable)
- Stability across packaging types (bottles, blister, carton)
What contract manufacturing suppliers typically handle dexchlorpheniramine maleate?
Answer: The best CMO fit is less about the molecule and more about the dose form capability and antihistamine experience.
CMO selection pattern
- OSD: tablet press capability, blending uniformity, in-process controls, dust collection and allergen cross-contamination strategy.
- Liquids: validated blending tanks, filling lines, filter or microbial control systems, preservative compatibility.
Manufacturing documentation to require
- Batch manufacturing record template and ability to incorporate your specs
- Stability protocol and accelerated/long-term data
- Change control and tech transfer timeline
Which supply agreements and regulatory packages are typical for this API?
Answer: Supplier agreements for dexchlorpheniramine maleate generally cover:
- Supply quantity and lead times with safety stock options
- Specification control and impurity acceptance
- Change notification for process/starting material/source changes
- Documentation deliverables (CoA, impurity report, stability summary, GMP statements)
Common regulatory package components
- DMF or equivalent dossier entry (for API)
- Site master file support or CEP/Certificate packages (as applicable)
- Finished-dose regulatory module support if importing/filing
How strong is supplier competition for dexchlorpheniramine maleate?
Answer: Competition is usually moderate. API sourcing is accessible, but reliable dossier-backed supply is less universal. Finished-dose supply depends on local licensing and labeling requirements.
Practical procurement implication
- You can usually qualify multiple suppliers for commercial supply.
- Fewer suppliers can reliably support dossier submissions and consistent impurity profiles needed for filings.
Key supplier diligence risks specific to dexchlorpheniramine maleate
Answer: The highest recurring risks in generic antihistamine sourcing are documentation gaps, impurity drift, and formulation concentration variability for liquids.
Risk categories
- Specification mismatch (assay or related substances not aligned to your target)
- Salt form inconsistency (maleate salt control and characterization)
- Liquid formulation microbiology (especially for multi-dose bottles)
- Batch-to-batch variability (blending uniformity and filling accuracy)
Key Takeaways
- Dexchlorpheniramine maleate supply is accessible through both API manufacturers and finished-dose generic manufacturers, with availability varying by region and regulatory status.
- Procurement value concentrates in supplier GMP status, impurity and assay control, and regulatory dossier readiness rather than in raw supplier count.
- For finished-dose syrups/solutions, microbiology, preservative efficacy, and concentration uniformity controls are decisive.
- For filings and regulatory submissions, prioritize suppliers with DMF/CEP-style documentation packages and consistent change-control practices.
FAQs
- What certifications should I request for dexchlorpheniramine maleate API from a supplier?
- Can I qualify multiple dexchlorpheniramine maleate API sources without reformulation in finished dosage forms?
- What batch documentation is most important for importing dexchlorpheniramine maleate finished tablets or syrup?
- How do suppliers control impurity profiles for maleate salts in dexchlorpheniramine maleate API?
- What quality checks matter most for dexchlorpheniramine maleate syrup concentration and microbial limits?
References (APA)
- [No sources were provided in the prompt to cite.]
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