Share This Page
Suppliers and packagers for generic pharmaceutical drug: probenecid; sulopenem etzadroxil
✉ Email this page to a colleague
probenecid; sulopenem etzadroxil
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Iterum Therap | ORLYNVAH | probenecid; sulopenem etzadroxil | TABLET;ORAL | 213972 | NDA | ITERUM THERAPEUTICS US LIMITED | 81153-100-01 | 1 BOTTLE in 1 CARTON (81153-100-01) / 10 TABLET, FILM COATED in 1 BOTTLE | 2025-07-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: probenecid; sulopenem etzadroxil
PROBENECID and Sulopenem Etzadroxil Suppliers: Who Supplies APIs, Intermediates, and Finished Dosage Forms
Probenecid and sulopenem etzadroxil are supplied through a mix of branded finished-dose manufacturers and contract supply of drug substance (API) and key intermediates. Public supplier visibility is uneven: probenecid has a mature, multi-supplier market; sulopenem etzadroxil has narrower, pathway-dependent supply chains tied to the specific formulation and regulatory dossier.
Who are the API suppliers for Probenecid?
Probenecid (uricosuric drug) is typically supplied as drug substance (API) by specialty generics/API houses and finished-dose manufacturers that also source API under contract. In practice, probenecid supply often comes from:
- API manufacturers in India and China that supply probenecid to branded and generic finished-dose producers.
- Contract API suppliers used by multiple dosage-form makers because probenecid is a low- to mid-value API with stable demand.
- Finished-dose producers that dual-source API internally or via qualified third-party API manufacturers.
How many suppliers typically cover Probenecid manufacturing?
For mature small-molecule uricosurics like probenecid, market coverage usually includes multiple qualified suppliers across at least two geographies (commonly India and China) and at least one or more EU/US-adjacent quality-assured sources via importer/distributor networks.
What manufacturing forms are supplied for Probenecid?
- Probenecid API (oral tablets are typical in legacy markets)
- Probenecid intermediates and/or process chemicals (sold to API makers, less visible publicly)
Who manufactures finished Probenecid tablets and brands?
Finished-dose probenecid typically appears as legacy branded products in some markets and generics in others. Finished-dose supply is handled by:
- Generic pharmaceutical companies with established oral solid dose manufacturing
- Branded manufacturers where probenecid is used as a component to support co-therapy regimens (historically with antibiotics requiring probenecid “boosting”)
What dosage forms are commonly distributed?
- Oral tablets (immediate release)
Who are the API and formulation suppliers for Sulopenem Etzadroxil?
Sulopenem etzadroxil is an oral carbapenem-like prodrug class antibiotic. Supply depends heavily on the exact dossier, the prodrug conversion performance, and the manufacturing know-how for the etzadroxil ester.
Most procurement packages for sulopenem etzadroxil fall into two buckets:
- API (drug substance) suppliers capable of producing sulopenem etzadroxil to dossier specifications.
- Contract finished-dose manufacturers producing the final tablets/capsules under strict release testing.
How supply is constrained for Sulopenem Etzadroxil
Sulopenem etzadroxil supply chains are usually narrower than probenecid because:
- prodrug-quality requirements are higher
- analytical control strategy (impurities, residual solvents, particle properties depending on salt/form) is critical
- regulatory dossier dependence makes supplier substitution slower and more expensive
What manufacturing forms are typically supplied?
- Sulopenem etzadroxil API (or API intermediates plus final conversion depending on the contract model)
- Final oral dosage form (tablets or capsule equivalents depending on the marketed product)
What suppliers cover Sulopenem Etzadroxil clinical and commercial launches?
Commercial launch supply is usually coordinated between:
- the originator or dossier holder (or sponsor)
- manufacturing contractors responsible for API and finished dose
- local marketing authorization holders who distribute and manage batch release
Because sulopenem etzadroxil is a prodrug antibiotic, batch-release testing and stability protocols drive supplier qualification. Supplier lists are often controlled through qualification agreements rather than broad public distribution.
How do procurement models work for Probenecid vs Sulopenem Etzadroxil?
Probenecid procurement model
- Multi-supplier API base
- Easier substitution among qualified API sources
- Lower analytical complexity versus prodrugs
Sulopenem Etzadroxil procurement model
- Fewer qualified API suppliers
- Tighter coupling between API lot and finished-dose performance
- Greater reliance on a small number of contract manufacturers with dossier-aligned process parameters
What are the main contract supply barriers for these drugs?
For Probenecid
- Limited but manageable regulatory and impurity-spec harmonization across suppliers
- Distributor dependence on batch availability
For Sulopenem Etzadroxil
- Impurity profile control and prodrug stability
- Process validation and tech-transfer requirements
- Tight impurity specification and degradation product monitoring
- Regulatory re-qualification time when swapping suppliers
Which geographies supply most of Probenecid and Sulopenem Etzadroxil?
Probenecid
Commonly sourced from:
- India and China (API)
- Europe and North America (finished-dose and distribution via local marketing entities)
Sulopenem Etzadroxil
Commonly sourced from:
- Asia-based API and contract manufacturing ecosystems (India/China are typical sources for prodrug APIs and oral solid dose contractors)
- Local marketing authorization holders for distribution and batch release in target markets
What Orange Book status is relevant for supplier selection?
No Orange Book status can be assigned from the input provided, and neither probenecid nor sulopenem etzadroxil details are provided with NDA/ANDA identifiers.
Key Takeaways
- Probenecid typically has a broader, more substitutable API supply base than prodrug antibiotics.
- Sulopenem etzadroxil supply is more constrained and dossier-dependent, with supplier qualification and tech transfer acting as major procurement barriers.
- Supplier selection for sulopenem etzadroxil is more likely to be limited by performance and impurity control tied to the approved product process.
FAQs
- Can I source Probenecid from multiple qualified API suppliers without revalidation?
- What tests most affect acceptance of Sulopenem Etzadroxil API lots (impurities, stability, residual solvents)?
- How do contract manufacturing agreements typically allocate responsibility for batch release for oral antibiotics?
- What typical lead times differ between Probenecid API and Sulopenem Etzadroxil API supply?
- How does finished-dose manufacturing choice (tablet vs capsule) change Sulopenem Etzadroxil supplier qualification?
References (APA)
No sources were provided in the prompt, and no regulatory or supplier-specific documents were cited.
More… ↓
