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Suppliers and packagers for generic pharmaceutical drug: ROLAPITANT HYDROCHLORIDE
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ROLAPITANT 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 |
|---|---|---|---|---|---|---|---|---|---|
| Tersera | VARUBI | rolapitant hydrochloride | TABLET;ORAL | 206500 | NDA | TerSera Therapeutics LLC | 70720-101-02 | 2 TABLET in 1 BLISTER PACK (70720-101-02) | 2015-10-07 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: ROLAPITANT HYDROCHLORIDE
Who Supplies Rolapitant Hydrochloride for Drug Manufacture and Formulation?
Rolapitant hydrochloride supply is concentrated around companies that (i) make the active pharmaceutical ingredient (API) or (ii) provide drug-substance intermediates used to build rolapitant and then convert to rolapitant hydrochloride under controlled salt formation. For procurement and risk planning, treat rolapitant hydrochloride as two supply streams: API and salt/formulation-ready API.
Because “suppliers” can mean different entities (API makers vs. distributors vs. contract manufacturing organizations), buyers typically screen against three evidence points: (1) API manufacturing capability, (2) documented regulatory linkage to rolapitant hydrochloride, and (3) salt-form control (HCl salt formation) with traceable specifications.
Rolapitant Hydrochloride: What Buyers Actually Purchase
Rolapitant hydrochloride is supplied in one of these practical forms:
- Rolapitant base (free base) converted to rolapitant HCl during manufacturing or compounding. Salt formation is controlled by pH, solvent system, and crystallization parameters to lock impurity profile and polymorph behavior.
- API as rolapitant hydrochloride with predefined specifications for identity, assay, water content, residual solvents, and related substances.
- Intermediate supply for API build (for contracted API production), where suppliers provide key building blocks under QMS controls but do not sell the finished salt.
Procurement should map each supplier offer to which of the above it is.
Which Types of Companies Supply Rolapitant Hydrochloride?
1) API Manufacturers
These are the highest-friction suppliers because they own the API process, quality system, and regulatory-grade batch history. They supply either rolapitant hydrochloride directly or rolapitant base plus HCl salt conversion instructions under a validated manufacturing agreement.
2) CDMOs and Contract API Salt-Formulation Providers
These vendors produce rolapitant hydrochloride under contract, even when the upstream API originates from another party. They are common in regions where buyers consolidate manufacturing in a single facility for easier QA and release.
3) Distributors and Chemical Traders
These firms resell API or salt forms. They can be useful for early scouting, but they usually do not control the upstream API process. For clinical or commercial-scale manufacture, their value depends on whether they can provide full COA, impurity profile, and QMS traceability tied to a validated API source.
What Defines a “Rolapitant Hydrochloride Supplier” in Procurement Terms?
A supplier counts as credible for manufacturing supply when it can meet these operational criteria:
- Documented API/salt identity and quality controls
- Assay for rolapitant hydrochloride
- Related substances/impurities (including known impurities and unspecified impurity limits)
- Water content (if specified)
- Residual solvent limits (if applicable)
- Release documentation
- Batch record traceability to source process
- Certificate of Analysis (COA) per batch
- Stability and shipping conditions if relevant
- Salt-form consistency
- HCl salt formation control (pH, crystallization, drying method)
- Evidence that the salt form is consistent across lots
- Regulatory readiness
- DMF/EDMF linkage for the API or salt (if held by the manufacturer)
- Willingness to support regulatory filings and quality audits
Regulatory Linkage: How Buyers Identify the Real Rolapitant Supply Chain
Rolapitant is an NK1 receptor antagonist used as part of antiemetic regimens. In practice, buyers identify the “real” manufacturing supply chain via regulatory filings for rolapitant (and, where applicable, salt form). For procurement-grade evidence, the chain typically looks like:
- Original API and process holder (often the market authorization holder’s supply chain or a licensed manufacturer)
- API manufacturer of record
- Salt formation step supplier or internal salt-formulation within the API manufacturer
- Drug product manufacturing sites that may specify API lot requirements
Because “suppliers” varies by whether the goal is API supply, salt-form supply, or distribution, the regulatory chain is the most reliable way to narrow the supplier list to those that can actually sell rolapitant hydrochloride at scale.
Rolapitant Hydrochloride: Practical Supplier Due Diligence Checklist
Use this screen to shortlist suppliers fast:
- Confirm the exact SKU sold
- Rolapitant hydrochloride, not rolapitant free base
- Check impurity profile control
- Compare related substances across offered lots
- Validate salt-form acceptance
- Supplier provides salt-form identity testing (e.g., polymorph or crystallinity method as specified)
- Residual solvent and elemental impurities
- Match ICH-aligned limits where required
- Consistency of physical properties
- Particle size distribution, bulk density, flow properties (critical for dosing and blending)
- Audit and QMS
- Ability to pass vendor qualification and GMP compliance review
Key Takeaways
- Rolapitant hydrochloride supply is best handled as API supply plus salt-form control (HCl conversion and crystallization) under a traceable QMS.
- Supplier credibility hinges on batch-level COAs, impurity control, and salt-form consistency, not on reseller status.
- The most reliable method to identify true suppliers is via regulatory-linked API manufacturing routes (API holder and process evidence), then map salt-form responsibility.
FAQs
What is the most important qualification for a rolapitant hydrochloride supplier?
They must control and document HCl salt formation quality plus provide batch-level impurity and specification compliance (assay, related substances, residual solvents, water content).
Do distributors count as rolapitant hydrochloride suppliers?
They can supply material, but they typically do not control the upstream API process. For manufacturing use, you need full traceability to the actual API/salt producer.
How do buyers verify the supplier is providing the HCl salt, not the free base?
Require identity testing tied to the hydrochloride form plus a COA that explicitly references rolapitant hydrochloride and its specification set.
What documentation matters most for clinical or commercial supply?
COA per batch, QMS/GMP status, impurity profile, and stability or handling guidance aligned to the buyer’s quality system.
Is salt-formulation always done by the same firm that makes the API?
Often it is integrated with API manufacture, but not always. Some supply chains split API manufacture and contract salt formation.
References
[1] U.S. Food and Drug Administration. Drug Trials Snapshots: Rolapitant (Varies by product application and listing). FDA. https://www.fda.gov/ (accessed via FDA drug pages).
[2] European Medicines Agency. Public assessment reports and product information for rolapitant-containing products (varies by procedure and product). EMA. https://www.ema.europa.eu/
[3] International Council for Harmonisation. ICH Q3A(R2): Impurities in New Drug Substances; ICH Q3B(R2): Impurities in New Drug Products. ICH. https://www.ich.org/
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