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Suppliers and packagers for generic pharmaceutical drug: DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE
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DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Viiv Hlthcare | JULUCA | dolutegravir sodium; rilpivirine hydrochloride | TABLET;ORAL | 210192 | NDA | ViiV Healthcare Company | 49702-242-13 | 30 TABLET, FILM COATED in 1 BOTTLE (49702-242-13) | 2017-11-21 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Pharmaceutical Drug Supply: Dolutegravir Sodium and Rilpivirine Hydrochloride
Who supplies dolutegravir sodium for APIs and intermediates?
Dolutegravir sodium (API and intermediate supply chain) is sourced globally from established small-molecule API manufacturers and API intermediate producers. Common supplier types include:
- API manufacturers producing dolutegravir-based active pharmaceutical ingredient (API) under DMF or CEP
- Intermediate suppliers making dolutegravir key intermediates (cyclization and functional group buildout steps)
- Contract manufacturers handling final crystal form controls for dolutegravir sodium specification compliance
What supplier profile matters for dolutegravir sodium?
For dolutegravir sodium, procurement is typically structured around:
- DMF/CEP coverage for regulatory submission readiness
- Salt-form control (dolutegravir sodium) and impurity profile alignment to approved specifications
- Supply capacity consistent with HIV regimen demand cycles
- Quality systems consistent with GMP audits (US FDA, EU GMP, or WHO PQ readiness depending on target markets)
Who supplies rilpivirine hydrochloride for APIs and intermediates?
Rilpivirine hydrochloride (API and intermediate supply chain) is supplied by global small-molecule API and intermediate producers. Typical supply coverage includes:
- API manufacturers producing rilpivirine hydrochloride API (often supported by DMF/CEP)
- Intermediate suppliers producing rilpivirine key fragments used in final assembly
- Contract manufacturers supporting purification and hydrochloride salt formation controls
What supplier profile matters for rilpivirine hydrochloride?
For rilpivirine hydrochloride, procurement typically emphasizes:
- Hydrochloride salt specification control
- Impurity profile consistency, especially for residual solvents and synthesis-related impurities
- Polymorph/crystal habit control where required by the finished dosage manufacturer
- Shipping and hold-time performance to prevent degradation-related rejects
How do suppliers typically map to procurement categories?
In market practice, “supplier” for these two APIs usually breaks into three procurement categories:
-
API manufacturer (direct supply)
- Supplies dolutegravir sodium and/or rilpivirine hydrochloride API
- Provides DMF/CEP or dossier support package
-
Intermediate supplier (cascade supply)
- Supplies dolutegravir or rilpivirine key intermediates
- Supports API manufacturer buildout and purification steps
-
GMP contract manufacturer (fill-finish or conversion)
- Produces API conversion (salt formation, recrystallization)
- Supports crystal form control and batch release analytics
What are the key compliance gates suppliers must meet?
For both dolutegravir sodium and rilpivirine hydrochloride, buyers usually require evidence aligned to:
- GMP compliance (facility approval, inspection history)
- Regulatory dossier support (DMF references, CEP availability, analytical methods)
- CoA coverage with batch-specific HPLC/impurity data
- Stability program adherence for assigned retest and shelf-life periods
- Nitrosamine and genotoxic impurity controls where applicable for HIV small molecules
Supplier selection matrix used by buyers (operational checklist)
Below is the typical selection lens used in API vendor qualification for these two molecules:
| Qualification axis | Dolutegravir sodium | Rilpivirine hydrochloride |
|---|---|---|
| Salt-form specification | Dolutegravir sodium | Rilpivirine hydrochloride |
| Regulatory support | DMF/CEP availability | DMF/CEP availability |
| Impurity control | Targeted synthesis impurities alignment | Targeted synthesis impurities alignment |
| Analytical package | Validated methods, batch CoA | Validated methods, batch CoA |
| Quality systems | GMP audit-ready documentation | GMP audit-ready documentation |
| Manufacturing continuity | Batch-to-batch consistency | Batch-to-batch consistency |
Key procurement risks to manage across suppliers
Even when supplier identity is known, buyers manage molecule-level risks:
- Salt formation drift (especially for hydrochloride salts like rilpivirine HCl)
- Impurity threshold excursions tied to upstream intermediate variability
- Batch release delays from method transfer gaps or analytical staffing constraints
- Crystal form changes causing downstream formulation instability or rejection
- Geopolitical and logistics interruptions impacting supply continuity
Key Takeaways
- Dolutegravir sodium and rilpivirine hydrochloride are sourced through a mix of API manufacturers, intermediate suppliers, and GMP contract conversion/purification providers.
- Supplier qualification for both molecules centers on salt-form control, impurity profile consistency, and regulatory dossier support (DMF/CEP and CoA analytics).
- Procurement success depends less on broad manufacturer capability and more on batch-to-batch reproducibility aligned to approved specifications and stability programs.
FAQs
1) What determines whether an API supplier is acceptable for dolutegravir sodium?
The supplier must meet GMP expectations and provide dossier support (DMF/CEP where relevant) plus batch CoA data aligned to approved impurity and salt specifications.
2) What determines whether an API supplier is acceptable for rilpivirine hydrochloride?
The supplier must demonstrate consistent hydrochloride salt formation, impurity profile control, and a complete validated analytical package for batch release.
3) Are intermediate suppliers considered “suppliers” for these drug substances?
Yes. Many API manufacturers qualify intermediate suppliers as part of the overall supply chain that impacts final API impurity profile and quality.
4) What documents buyers typically require from API suppliers?
CoA with validated analytics, GMP audit documentation, and regulatory support files aligned to the intended market submission (DMF/CEP support).
5) What operational issues most often disrupt dolutegravir or rilpivirine API supply?
Impurity excursions, method transfer delays, and salt/crystal form inconsistencies that cause batch release delays or downstream formulation non-conformance.
References
[1] https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/centre-procedures
[2] https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-system-dmrs-drug-master-files-dmf
[3] https://www.who.int/teams/regulation-prequalification/regulation-and-prequalification-approaches/quality-assurance-pharmaceutical-products
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