Last updated: June 23, 2026
ORPHENGESIC is a branded analgesic product sold by various distributors across markets. Supplier coverage depends on (1) the specific national formulation strength (tablet vs. syrup vs. topical, where offered), (2) the marketing authorization holder in each country, and (3) the listed manufacturing sites and contract manufacturing relationships shown on the local product label or regulatory dossier.
No complete, country-specific supplier dataset (marketing authorization holder, manufacturing sites, API manufacturers, and key logistics/packaging contractors) is available in the provided information, so a complete supplier map cannot be produced without introducing unsupported claims.
Who supplies the ORPHENGESIC drug product (marketing authorization holder, manufacturer, packager)?
Answer: The supplier is the marketing authorization holder (MAH) and the labeled manufacturer for the specific strength and dosage form in the target country.
What supplier roles exist in an ORPHENGESIC supply chain?
Answer: Typical roles include:
- API manufacturer (the chemical supplier)
- Drug product manufacturer (tableting, encapsulation, bottling, or topical assembly)
- Secondary manufacturer (if different: filling, finishing)
- Packaging supplier (bottles, blisters, cartons, leaflets)
- Quality control testing labs (often site-based)
How do you identify the correct ORPHENGESIC supplier for a given market?
Answer: Use the product label and the local regulatory listing for:
- MAH name
- Labeled manufacturing site address(es)
- Strength and dosage form
- Batch release/testing site where indicated
What pharmaceutical API suppliers make the active ingredient(s) in ORPHENGESIC?
Answer: API suppliers vary by market and by which specific “ORPHENGESIC” formulation is sold.
How formulation differences change the API supplier list?
Answer: ORPHENGESIC may be sold as combination analgesic products in some jurisdictions. Different combinations and strengths change the API roster. Without the exact composition for the specific ORPHENGESIC SKU, API suppliers cannot be enumerated reliably.
Which companies are the contract manufacturers for ORPHENGESIC tablets, syrups, or other dosage forms?
Answer: The contract manufacturer is the labeled manufacturer on the dosage form packaging in the target country.
What manufacturing steps drive different supplier candidates?
Answer: Contract manufacturing shifts with dosage form:
- Tablets: blending, granulation (if used), compression, coating
- Syrups: compounding, sterilization (if applicable), bottling
- Topicals (if offered): mixing, filling, tube/pack assembly
How do distributors source ORPHENGESIC (importers vs. local wholesalers)?
Answer: Distributors source via local importers and wholesalers tied to the MAH supply contract for the licensed market.
What to look for in distributor networks?
Answer: Look for:
- Importer of record on local labeling
- Wholesaler listings tied to tenders and hospital procurement
- Trade name consistency across batch numbers
What is the Orange Book status of ORPHENGESIC, and does that reveal suppliers?
Answer: No answer can be given from the provided input because Orange Book coverage applies to FDA-approved US prescription drug applications and exclusivity/patent listings, and ORPHENGESIC is not confirmed here as an FDA-listed product with identifiable NDC-to-manufacturer mappings.
Does US listing exist for ORPHENGESIC?
Answer: Not determinable from the provided information.
What patent or regulatory filings identify ORPHENGESIC manufacturers and sites?
Answer: Manufacturer identity can be inferred from regulatory filings in markets that publish:
- Manufacturing authorization holders
- GMP certificates listing sites
- Product dossiers
- Batch release and quality control sites
No filings were provided in the prompt, so no supplier-linked regulatory citations can be made.
When do ORPHENGESIC supplier relationships change (renewals, site transfers, GMP updates)?
Answer: Supplier changes typically occur when:
- MAH switches manufacturing sites
- Contract manufacturers rotate for capacity or cost
- GMP compliance triggers site qualification updates
A timeline cannot be generated without market-specific dossier or GMP change records.
How many suppliers cover ORPHENGESIC supply in each country?
Answer: Usually one licensed manufacturer site per dosage form at launch, with additional qualified sites over time.
No country scope is provided, so counts cannot be stated.
Supplier comparison: How to benchmark ORPHENGESIC supply options by risk and cost
Answer: Supplier benchmarking should evaluate:
- GMP compliance history for the labeled manufacturing site
- Sterility/bioburden controls where relevant
- Lead times for API supply and packaging materials
- Change control frequency (site transfers or reformulations)
No supplier names are available from the provided input, so a comparison table cannot be produced.
Key Takeaways
- ORPHENGESIC supplier identification requires the specific country SKU (strength, dosage form, composition) because supplier names and manufacturing sites vary by market.
- The authoritative supplier list is the MAH and the labeled manufacturer on the local product packaging and regulatory listing.
- With only the drug name provided, a complete supplier roster (API, contract manufacturer, packager, and distributor) cannot be compiled without introducing unsupported claims.
FAQs
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How can I find the labeled manufacturer for ORPHENGESIC in my country?
Check the product box label and insert for MAH and manufacturing site address.
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Do ORPHENGESIC suppliers differ between tablets and syrups?
Yes, dosage forms often use different contract manufacturers and packaging systems.
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What documents show ORPHENGESIC batch manufacturing and quality release sites?
Local regulatory product dossiers and batch documentation standards used in that market.
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Can Orange Book listings identify ORPHENGESIC suppliers in the US?
Only if ORPHENGESIC is FDA-listed with NDC and linked patent and applicant/manufacturer data.
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What supplier risks matter most for ORPHENGESIC supply continuity?
API availability, GMP compliance of the labeled manufacturing site, and packaging material lead times.
References
(No sources were provided in the prompt, and no reliable regulatory or label datasets for ORPHENGESIC suppliers are cited here.)
