Last updated: May 26, 2026
Suppliers for Chlorpheniramine Polistirex and Hydrocodone Polistirex: Who Manufactures and Ships These Polistirex Products?
The supplier base for chlorpheniramine polistirex and hydrocodone polistirex is dominated by manufacturers that produce the polistirex-based extended-release formulations and by API and dosage-form suppliers used by branded and private-label holders. Exact supplier identity depends on the specific NDC, dosage strength, and label/market authorization, because both actives are commonly distributed as extended-release combinations where the market’s active ingredient, polymer system, and drug-product packaging are sourced through different supply contracts.
Because the request does not specify product strength, dosage form, NDC, labeler/MAH, country/market, or FDA/Orange Book listing, a complete, accurate “who are the suppliers” answer cannot be produced without risking material errors.
Which companies supply chlorpheniramine polistirex (extended-release) drug product?
Featured snippet answer: The drug product supplier is the FDA labeler (drug establishment) and, upstream, the manufacturer of the polistirex extended-release dosage form. In practice, the identity changes by NDC and market and is documented in FDA drug listing (structured product labels/labelers), manufacturer establishment records, and compendial/label strength-specific sources.
What determines the chlorpheniramine polistirex supplier list?
- NDC and labeler drive who manufactures the marketed product.
- Strength and combination (single-ingredient vs multi-ingredient) changes the production line.
- Market (US vs other jurisdictions) changes the authorized manufacturer and distributor network.
What upstream supply chain pieces matter?
- API manufacture (chlorpheniramine base) and its release specifications
- Polistirex delivery-system availability (polymeric carrier supply)
- Extended-release tablet/suspension manufacturing (compression/suspension coating line, controlled release validation)
- Finishing and packaging (bottling/blister for the specific dose form)
Which companies supply hydrocodone polistirex (extended-release) drug product?
Featured snippet answer: Hydrocodone polistirex drug product supply is tied to the labeler/drug establishment and to the extended-release manufacturer for the polistirex-based formulation. Supply is typically re-negotiated by contract manufacturing organizations (CMOs) and by brand holders, and it varies by NDC and market authorization.
What makes hydrocodone polistirex supplier identification more complex?
- Controlled substance handling requirements tighten the list of qualified supply chain participants.
- DEA registration and distribution controls affect who can supply finished dosage forms and where they can ship.
- Any change in the drug-product manufacturer can trigger new supply qualification and regulatory updates.
How do polistirex extended-release formulations change the supplier landscape?
Polistirex-ER products rely on a controlled-release platform. In practice, the “supplier” question splits into at least three layers:
1) API suppliers
- Chemical manufacture of chlorpheniramine and hydrocodone (or corresponding salts/processed forms used in final specs)
2) Drug product formulation and dose-form suppliers
- The entity that produces the extended-release polistirex dosage form with the branded label’s dissolution and release profile
3) Packaging and distribution suppliers
- Labeler/wholesaler distributors, plus packaging sites that handle NDC-specific configuration
What are typical US sources used to identify polistirex product suppliers?
A defensible supplier list for either chlorpheniramine polistirex or hydrocodone polistirex is normally compiled from:
- FDA Structured Product Labels (SPL) and drug establishment records for the labeler and manufacturing establishments
- NDC Directory for labeler and dosage-form mapping
- Orange Book only where applicable (often more relevant for active ingredients and specific approvals, not always for all combinations/ER versions)
- Drug listing and current manufacturing location data used in supply chain due diligence
- For controlled substances, DEA registrant mapping is sometimes required for operational confirmation
What generic or private-label entry risks exist for polistirex ER products?
Featured snippet answer: For extended-release polymer platform products, the main entry risks cluster around formulation replication and bioequivalence/dissolution performance rather than API-only sourcing.
Common technical/IP and development constraints
- Replicating drug release kinetics tied to polistirex matrix properties
- Matching dissolution profile across batches and scale
- Achieving consistent pharmacokinetic exposure (Cmax, AUC) with the required BE metrics
Key Takeaways
- “Supplier” for chlorpheniramine polistirex and hydrocodone polistirex is not a single list. It is NDC-specific and changes by labeler and manufacturing establishment.
- Upstream sourcing spans API, polistirex-based extended-release formulation, and packaging/finished-goods distribution.
- A complete supplier roster requires product-identifying inputs (NDC/strength/labeler and market); without them, any company-specific claim would be unreliable.
FAQs
- How can I identify the FDA labeler for chlorpheniramine polistirex by NDC?
- Which databases list drug product manufacturers for extended-release polistirex formulations?
- What manufacturing changes typically require notification for polistirex extended-release products?
- How do DEA registrations affect hydrocodone polistirex supplier qualification?
- What formulation and dissolution factors govern polistirex extended-release generic development?
References
- U.S. Food and Drug Administration. Drug Establishment Registration and Drug Listing (data sources and SPL/NDC-linked labeler/manufacturer records). FDA.
- FDA. National Drug Code (NDC) Directory. FDA.
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.
- U.S. Drug Enforcement Administration. DEA registration and controlled substance manufacturing/distribution framework. DEA.
