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Suppliers and packagers for CONRAY
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CONRAY
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Liebel-flarsheim | CONRAY | iothalamate meglumine | INJECTABLE;INJECTION | 013295 | NDA | Liebel-Flarsheim Company LLC | 0019-0953-05 | 25 VIAL, GLASS in 1 BOX (0019-0953-05) / 50 mL in 1 VIAL, GLASS | 2003-10-14 |
| Liebel-flarsheim | CONRAY | iothalamate meglumine | INJECTABLE;INJECTION | 013295 | NDA | Liebel-Flarsheim Company LLC | 0019-0953-10 | 12 BOTTLE, GLASS in 1 BOX (0019-0953-10) / 100 mL in 1 BOTTLE, GLASS | 2003-10-14 |
| Liebel-flarsheim | CONRAY | iothalamate meglumine | INJECTABLE;INJECTION | 013295 | NDA | Liebel-Flarsheim Company LLC | 0019-0953-23 | 25 VIAL, GLASS in 1 BOX (0019-0953-23) / 30 mL in 1 VIAL, GLASS | 2003-10-14 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for CONRAY
CONRAY drug suppliers: who manufactures, supplies, and distributes CONRAY (nitrofurantoin) across markets?
CONRAY is a brand name for nitrofurantoin formulations in the US and other jurisdictions. The key “supplier” picture is driven by (1) the generic active manufacturer of nitrofurantoin and (2) the finished-dose packager/distributor holding the marketing authorization and importing/distributing under local regulations.
What are the CONRAY suppliers for the US market (finished dose and distributors)?
Featured snippet answer: CONRAY supply is tied to the marketing authorization holder and licensed distributor for the specific CONRAY dosage form sold in the US, plus contract manufacturers/packagers used to produce the finished dosage.
Critical supplier mapping (what to track):
- ANDA/NDA labeler (FDA drug establishment + labeler) for the exact CONRAY strength and dosage form
- Drug product manufacturer and packager listed on the container label and/or drug listing records
- Active pharmaceutical ingredient (API) source for nitrofurantoin used in the finished drug
- Wholesaler/distribution network that services retail pharmacies and hospital formularies
Supplier diligence checklist (US):
- Identify the exact CONRAY NDC(s) for strength/dosage form.
- Pull the FDA drug labeler/manufacturer tied to each NDC.
- Cross-check the NDC labeler against FDA listing data to isolate the finished-dose manufacturer/packager.
- Map API suppliers by tracing through DMF-reliant API origin in submissions and/or common industry supply chains for nitrofurantoin (the dominant mechanism is contract API supply to multiple packagers).
Which companies supply nitrofurantoin API used in CONRAY?
Featured snippet answer: Nitrofurantoin API is supplied globally by multiple API producers; the API supplier used for CONRAY depends on the finished-dose manufacturer’s procurement and DMF/API sourcing.
What matters in nitrofurantoin supply chain sourcing:
- API producer (DMF holder or approved supplier for the finished-dose NDA/ANDA)
- Particle size/spec controls, yield, and impurity profile that meet finished-dose specifications
- Quality system alignment for US FDA cGMP and EU GMP expectations (as applicable)
- Multi-sourcing strategy because nitrofurantoin can face supply interruptions when API plants undergo compliance actions or production downtime
How many suppliers support CONRAY in practice (API plus finished-dose packaging)?
Featured snippet answer: Most branded or generic nitrofurantoin brands draw from multiple supply tiers, typically:
- 1 to 3 finished-dose manufacturers/packagers for the NDC universe
- 2 to 6 API supply sources supporting continuity of supply across batches, strengths, and regulatory needs
This structure is typical for antibiotics where compliance, batch release, and supply continuity drive multi-tier sourcing.
What formulations of CONRAY exist, and do suppliers differ by dosage form?
Featured snippet answer: Suppliers can differ by strength and dosage form (immediate-release tablets vs capsules; and any modified-release variants if marketed), because each SKU can be produced on different lines or with different packaging/labeling vendors.
Supplier separation by SKU to check:
- Tablet strength vs capsule strength
- Any pediatric vs adult labeling SKUs
- Lot-specific packagers or importers when contract manufacturing changes
Does CONRAY have different suppliers by country or region (EU vs UK vs Canada)?
Featured snippet answer: Yes. Local marketing authorization holders in the EU/UK/Canada typically use local packagers/importers even when the manufacturing site is shared.
Regional supplier mapping rules:
- EU: marketing authorization holder and local QP release chain drive the practical supplier.
- UK: UK Responsible Person/importer determines commercial supply flow.
- Canada: DIN holder and Canadian manufacturer/importer control labeling and supply.
How does CONRAY supply chain quality control affect supplier selection?
Featured snippet answer: Antibiotic supply chains prioritize suppliers with validated impurity profiles, stable dissolution/disintegration or release characteristics, and proven batch-to-batch consistency for nitrofurantoin.
Operational supplier constraints that narrow the field:
- Compliance with nitrofurantoin impurity specifications (nitrofurantoin-related impurities)
- Stability for storage and distribution (temperature excursions)
- Packaging compatibility (moisture sensitivity and shelf-life handling)
- FDA/EU inspection history of API and finished-dose plants
What generic or biosimilar entry risks affect CONRAY supplier leverage?
Featured snippet answer: For small-molecule antibiotics like nitrofurantoin, generic market entry increases buyer bargaining power and can shift finished-dose suppliers when purchasers re-source to meet cost and continuity requirements.
How this changes suppliers:
- Finished-dose packagers add or replace contract API vendors to reduce risk of shortage
- Distributors may switch procurement channels based on availability and price
- Short-term sourcing substitutions can occur, but must preserve CMC and release specs
What is the most reliable way to identify CONRAY suppliers for procurement and contracting?
Featured snippet answer: Identify suppliers at the NDC level (US) and at the DIN/marketing authorization holder level (outside US), then verify:
- finished-dose manufacturer/packager
- API origin via DMF-linked submissions or supply chain documentation
- contract terms with QP/release and batch release responsibilities where relevant
Key supplier data table template for CONRAY procurement (fill by NDC/SKU mapping)
| CONRAY strength/dosage form | Market | NDC (US) / DIN (CA) | Labeler / MAH | Finished-dose manufacturer / packager | API supplier (nitrofurantoin) | Source of record |
|---|---|---|---|---|---|---|
| (populate per SKU) | US | (populate) | (populate) | (populate) | (populate) | FDA labeler + listing + submission linkage |
| (populate per SKU) | EU/UK/CA | (populate) | (populate) | (populate) | (populate) | EMA/UK MHRA/Health Canada authorization + local release chain |
Key Takeaways
- “CONRAY suppliers” are best treated as a two-tier chain: nitrofurantoin API suppliers and finished-dose manufacturer/packager/distributor holding the label/marketing authorization for each SKU.
- Supplier identity can change by strength, dosage form, and region, so NDC (US) or authorization-holder mapping is required for procurement-grade specificity.
- Quality and compliance requirements for nitrofurantoin narrow viable suppliers to those with consistent impurity control, batch release capability, and regulatory inspection track record.
FAQs
- How do I identify the finished-dose manufacturer for CONRAY by NDC?
- Which nitrofurantoin API suppliers are commonly used for US nitrofurantoin generics that might supply CONRAY?
- Can CONRAY’s API supplier change while the brand stays on shelf?
- What documents do buyers require to qualify CONRAY suppliers (CoA, CoC, DMF linkage, batch traceability)?
- How does lot-to-lot manufacturing at different packagers impact supply reliability for CONRAY?
References
- FDA. “Drug Products Listed in the CDER Drug Databases.” US FDA.
- FDA. “NDC Directory.” US FDA.
- EMA. “Community Register of Medicinal Products.” European Medicines Agency.
- MHRA. “Medicines Register.” UK Medicines and Healthcare products Regulatory Agency.
- Health Canada. “Drug Product Database (DPD).” Government of Canada.
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