Share This Page
Suppliers and packagers for generic pharmaceutical drug: RALTEGRAVIR POTASSIUM
✉ Email this page to a colleague
RALTEGRAVIR POTASSIUM
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Msd Sub Merck | ISENTRESS | raltegravir potassium | POWDER;ORAL | 205786 | NDA | Merck Sharp & Dohme LLC | 0006-3603-60 | 60 PACKET in 1 CARTON (0006-3603-60) / 1 GRANULE, FOR SUSPENSION in 1 PACKET (0006-3603-01) | 2013-12-20 |
| Msd Sub Merck | ISENTRESS | raltegravir potassium | POWDER;ORAL | 205786 | NDA | Merck Sharp & Dohme LLC | 0006-3603-61 | 60 PACKET in 1 CARTON (0006-3603-61) / 1 GRANULE, FOR SUSPENSION in 1 PACKET (0006-3603-01) | 2013-12-20 |
| Msd Sub Merck | ISENTRESS | raltegravir potassium | TABLET, CHEWABLE;ORAL | 203045 | NDA | Merck Sharp & Dohme LLC | 0006-0473-61 | 60 TABLET, CHEWABLE in 1 BOTTLE (0006-0473-61) | 2011-12-21 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: RALTEGRAVIR POTASSIUM
RALTEGRAVIR POTASSIUM suppliers: API and key intermediate sourcing for generic and branded production
Raltegravir potassium supplier landscape depends on whether you buy (1) active pharmaceutical ingredient (API) or (2) key intermediates (including the bicyclic core and oxazine/urea-bearing fragments used in the raltegravir synthetic route). For licensing, manufacturing, and Paragraph IV risk mapping, sourcing is best treated as API+crystal form control plus intermediate availability, because cobalt-level changes in polymorph/solvate/hydrate handling can drive QC failures and revalidation costs.
Answer at a glance (what to buy and where sourcing concentrates)
- Most buyers source raltegravir potassium API from Indian and China-based API producers that also supply related integrase inhibitor building blocks.
- Intermediate suppliers tend to supply “step 2/3/4” intermediates under custom synthesis for multiple integrase inhibitor programs.
- Formulation OEM selection is typically independent of API supply, since tablets require distinct excipient systems and milling/granulation controls tied to the API’s crystallinity and particle size distribution.
Scope note (supplier types)
- API manufacturers: produce raltegravir potassium drug substance (often via upstream intermediates).
- Intermediate makers / custom synthesis: sell or synthesize core intermediates used to assemble raltegravir.
- CDMO/formulation contractors: compress and package raltegravir potassium tablets after drug substance release and incoming QC testing.
Because you requested “suppliers,” this report focuses on supplier categories and the sourcing pattern used in the market, rather than a permissive vendor list. A precise vendor roster requires Orange Book/FDA facility traceability and current FDA inspections, which varies by year and unit purchase volume.
Who supplies raltegravir potassium API in the market?
Featured snippet answer: Raltegravir potassium API sourcing concentrates in established generics API ecosystems, primarily India and China, with contract synthesis and sterile-grade QC capabilities around crystallization and polymorph control. API availability is typically routed through distributors that aggregate multiple upstream producers.
What buyer due diligence should focus on for raltegravir potassium API?
- Crystallinity/polymorph: raltegravir potassium is sensitive to solid-state form control. Buyers should request:
- batch-specific XRPD patterns
- DSC/TGA fingerprints
- stability data by storage condition
- polymorph-at-release and polymorph-after-transport documentation
- Particle size distribution (PSD): impacts tablet uniformity and dissolution.
- Impurity profile:
- genotoxic impurity reporting and control strategy
- residual solvents per ICH Q3C
- heavy metals per ICH Q3D
- Regulatory track record:
- DMF type and letter status (if applicable)
- inspection outcomes for the manufacturing site
How to map API suppliers to DMF/ANDA submissions
In practice, buyers map suppliers by:
- identifying the drug master file (DMF) references used in ANDAs for raltegravir potassium tablets
- cross-walking DMF-manufacturing sites to import/export records and supplier capability
- verifying the commercial API supplier matches the DMF site for consistency in regulatory submissions
Which companies make raltegravir potassium intermediates and custom synthesize integrase inhibitor building blocks?
Featured snippet answer: Intermediate suppliers are generally custom synthesis houses serving multiple integrase inhibitor programs, with contracts covering core bicyclic and urea/oxime-related steps that converge to raltegravir.
Intermediate sourcing pattern
Intermediate availability typically falls into:
- core bicyclic/aryl intermediates (assembled ring systems)
- side-chain fragment intermediates (urea/oxime and functionalization steps)
- final salt formation intermediates (potassium salt conversion with controlled crystallization)
What to ask for in intermediate supply agreements
- CoA with:
- impurity profile by HPLC/UPLC
- residual solvent analysis
- water content (Karl Fischer) where relevant
- CQA list and acceptance criteria aligned to target drug product
- change-control commitments for:
- route changes
- crystallization seed changes
- solvent system changes
What CDMOs supply raltegravir potassium tablets and packaging services?
Featured snippet answer: Tablet CDMOs typically subcontract the final formulation after an API supplier delivers drug substance that meets the CDMO’s solid-state specifications.
Why formulation outsourcing is independent from API
- Tablet performance depends on milling, granulation, compression force, and drying profiles.
- Many CDMOs accept multiple API sources if incoming QC passes.
- Some CDMOs also maintain their own preferred API “approved vendor list” based on dissolution and stability outcomes.
Key formulation process constraints
- particle size and flow for direct compression vs wet granulation
- binder/disintegrant compatibility with raltegravir potassium solid form
- dissolution method equivalence and method transfer
How strong is the supplier concentration risk for raltegravir potassium?
Featured snippet answer: Supplier concentration risk is non-trivial because solid-state form and impurity control depend on upstream crystallization and specific synthesis chemistry.
Risk areas
- single-plant reliance for the API salt form step
- limited alternative intermediate suppliers for key steps
- batch-to-batch polymorph drift caused by:
- temperature and solvent system changes
- seed lot differences
- drying time changes
Mitigation strategies
- dual-sourcing strategy at API release spec level, not only intermediate level
- qualification batches for each new supplier across:
- release specs
- stability timepoints
- dissolution and uniformity performance
How does supplier selection impact generic entry timing for raltegravir potassium?
Featured snippet answer: Delays are usually caused by solid-state and impurity validation cycles, not by tablet compression capacity. Supplier swaps trigger revalidation of:
- dissolution
- content uniformity
- impurity and degradant controls
- stability and shipping stress conditions
Typical sequencing
- lock API supplier and solid form early
- conduct formulation development using target API PSD and polymorph
- then qualify manufacturing tech transfer between batches
Which regulatory documents connect suppliers to FDA submissions for raltegravir potassium?
Featured snippet answer: FDA-facing supplier traceability is anchored to DMF references (for API) and CMC modules (for tablets). Supplier-to-submission matching is the highest value step for procurement, licensing, and litigation mapping.
What to extract from filings
- API manufacturing site addresses
- responsible manufacturers listed in CMC
- DMF submission numbers and cross-references
- change-control history for critical steps
Supplier comparison: API makers vs intermediate makers vs CDMOs
| Supplier type | Primary deliverable | Biggest procurement risk | Best use case |
|---|---|---|---|
| API manufacturer | raltegravir potassium drug substance | polymorph/impurity drift | ANDA/market production scaling |
| Intermediate maker | key raltegravir intermediates | step-specific control loss | route optimization or dual sourcing |
| CDMO | raltegravir potassium tablets | formulation performance variation | speed-to-market via established tablet lines |
| Distributor/agent | procurement access | price and lead-time variability | shortlisting multiple candidates quickly |
Key Takeaways
- Raltegravir potassium supply chains are built around API solid-state control and impurity governance, so supplier qualification must treat polymorph and PSD as hard CQA inputs.
- API sourcing concentrates in India and China ecosystems; intermediates are often custom-synthesized for multiple integrase inhibitor programs.
- Procurement decisions should be driven by regulatory traceability (DMF/CMC site alignment) and solid-state validation, not by vendor name alone.
- For generic programs, the fastest path is usually to lock API solid form and impurity profile early, then select a CDMO that can reproduce dissolution and stability with that specific drug substance.
FAQs
1) How do I qualify a new raltegravir potassium API supplier without risking polymorph drift?
Run qualification batches that include XRPD/DSC fingerprints at release and stability timepoints, plus PSD and dissolution comparability under the target method.
2) What solid-state attributes most affect raltegravir potassium tablet dissolution?
XRPD-verified solid form, PSD/flow properties, and residual solvent/water levels that influence dissolution kinetics.
3) Are intermediate suppliers interchangeable for raltegravir potassium synthesis?
Not fully. Step-level impurity profiles and functional group handling can shift degradants and drive reformulation or tighter impurity controls.
4) How does supplier change-control usually affect ANDA manufacturing timelines?
Route or crystallization changes can require updated stability lots, method verification, and CMC amendments that slow launch.
5) What documentation should procurement request from raltegravir potassium suppliers?
CoA with impurity, residual solvent, water content as applicable; solid-state characterization (XRPD/DSC); and batch traceability tied to manufacturing steps.
References (APA)
- FDA. (n.d.). Drug Master Files (DMFs). U.S. Food and Drug Administration.
- ICH. (2014). ICH Q3C: Impurities: Residual Solvents. International Council for Harmonisation.
- ICH. (2006). ICH Q3D: Guideline for Elemental Impurities. International Council for Harmonisation.
More… ↓
