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Suppliers and packagers for generic pharmaceutical drug: dihydroergotamine mesylate
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dihydroergotamine mesylate
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Baxter Hlthcare Corp | DIHYDROERGOTAMINE MESYLATE | dihydroergotamine mesylate | INJECTABLE;INJECTION | 216747 | ANDA | Baxter Healthcare Corporation | 36000-300-10 | 10 AMPULE in 1 CARTON (36000-300-10) / 1 mL in 1 AMPULE (36000-300-01) | 2025-01-07 |
| Gland | DIHYDROERGOTAMINE MESYLATE | dihydroergotamine mesylate | INJECTABLE;INJECTION | 215623 | ANDA | Gland Pharma Limited | 68083-466-10 | 10 AMPULE in 1 CARTON (68083-466-10) / 1 mL in 1 AMPULE | 2023-08-18 |
| Hikma | DIHYDROERGOTAMINE MESYLATE | dihydroergotamine mesylate | INJECTABLE;INJECTION | 040453 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9151-10 | 10 VIAL in 1 CARTON (0143-9151-10) / 1 mL in 1 VIAL | 2023-03-31 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Dihydroergotamine Mesylate: Supplier Landscape by Business-Critical Segment
Dihydroergotamine mesylate (DEM; typically sold as the drug substance or as intermediate inputs) is sourced through two practical channels: (1) API manufacturers of dihydroergotamine or dihydroergotamine mesylate and (2) ingredient distributors that aggregate pricing, lead times, and compliance paperwork for commercial and clinical supply chains. The DEM supply chain is dominated by European and Asian API and chemical manufacturers, with downstream distribution usually handled by global pharma ingredient brokers.
What types of suppliers exist for dihydroergotamine mesylate?
1) API manufacturers (drug substance producers)
These suppliers manufacture dihydroergotamine mesylate as the API or manufacture the free base and convert it to the mesylate salt under controlled conditions. Contracts typically cover:
- cGMP batch release (often CEP/DMF support in mature markets)
- validated salt formation and impurity control
- stability programs for the salt form
- packaging options aligned to pharma filing needs (bottles, bags, drums)
2) Specialty chemical suppliers (salt-form and scale-up capable)
Some suppliers sit between bulk APIs and fine chemicals, focusing on:
- salt formation capability (mesylate)
- intermediate chemistry and purification
- pilot-to-commercial transfer support
3) Pharma ingredient distributors (resellers and brokers)
These suppliers do not necessarily manufacture. They provide:
- landed pricing and inventory access
- regulatory documents (commonly COA, TSE/BSE where applicable, sometimes GMP letter if supported)
- logistics for commercial volumes and clinical trials
Who are the key suppliers for dihydroergotamine mesylate?
No single registry cleanly enumerates all “suppliers” for DEM across every jurisdiction, product form, and regulatory status. Supplier lists also vary by:
- salt form (mesylate vs base)
- grade (pharma vs research grade)
- release documentation (commercial COA vs full cGMP support)
Under a decision-ready framework, the only supplier groups that matter operationally are those that can support cGMP release and regulatory documentation for DEM as a drug substance or salt.
Supplier short-list by procurement role (actionable)
Below is the supplier map you can use to structure sourcing outreach and risk controls:
| Procurement role | Typical supplier archetype | What to verify in the supplier package |
|---|---|---|
| Drug substance (API) cGMP | API manufacturer | GMP certificate scope; batch release spec; impurity profile; DMF/CEP status (if claimed) |
| Salt-forming / intermediate capable | Specialty manufacturer | salt-formation SOP; residual solvents; genotoxic/impurity statements; stability support |
| Distribution (reseller) | Pharma ingredient distributor | whether they are the manufacturer of record; supply chain traceability; COA consistency |
Which geographies dominate DEM supply?
Dihydroergotamine and ergot-alkaloid chemistry supply tends to cluster in established manufacturing hubs with:
- experience in complex alkaloid purification
- established regulatory documentation systems for APIs
- scale capacity for high-potency compounds
The practical sourcing implication:
- EU-based and Asian API producers are typically the most relevant for direct API supply.
- Global distributors typically provide the fastest route to availability, but the manufacturer of record still drives quality and regulatory readiness.
What documents and compliance artifacts distinguish acceptable suppliers?
For DEM sourcing (API or salt), procurement teams should treat the following artifacts as go/no-go checkpoints:
Core quality package
- COA per batch (identity, assay, related substances, water content if applicable)
- specification limits aligned to intended market or internal use
- impurity statement consistent across supplier lots
Regulatory readiness
- GMP certificate for the manufacturing site and scope covering API/salt production
- DMF or CEP reference if the supplier claims it for filing support
- validated analytical methods or method summary if requested during audits
Supply chain and stability
- traceability of raw materials used for salt formation
- stability data (or at minimum real-time/accelerated plan) for dihydroergotamine mesylate
- packaging configuration and shelf-life declaration
How to compare suppliers for DEM without getting trapped by non-qualifying offers
Procurement and R&D teams often waste time on offers that are “available” but not “file-able.” Use the comparison criteria below to rank suppliers:
| Comparison axis | Supplier that wins for pharma use | Supplier that creates downstream risk |
|---|---|---|
| GMP status | cGMP production with API-level batch release | research grade, no GMP scope for DEM salt |
| Impurity control | stable impurity profile across lots | uncontrolled related substances or inconsistent COAs |
| Salt-form consistency | documented salt formation and solid-state controls | variable form/polymorph risk not addressed |
| Filing support | DMF/CEP and consistent regulatory narrative | “can support” with no documentation trail |
What does “dihydroergotamine mesylate supplier” usually mean in procurement terms?
In practical purchasing, a “supplier of dihydroergotamine mesylate” can mean one of three contract structures:
-
API manufacturer sells DEM mesylate directly
- fastest path to regulatory documentation
- requires negotiation on MOQs and lead times
-
Manufacturer makes DEM and partner converts to mesylate
- more complex change control
- more moving parts in impurity and salt-consistency assurance
-
Distributor supplies branded paperwork and ships from inventory
- quickest delivery
- higher risk if manufacturer-of-record changes without formal notifications
What are the business-critical risk points in DEM sourcing?
Dihydroergotamine is an ergot alkaloid. That class tends to carry heightened scrutiny on:
- impurity and residual solvent control during salt formation
- batch-to-batch reproducibility in alkaloid crystallization and purification
- solid-state form verification practices (identity and physical form)
So the risk is rarely “can you buy it.” The risk is “can you keep it compliant across batches and markets.”
Key Takeaways
- Dihydroergotamine mesylate supply is best approached via three supplier categories: API manufacturers, salt-forming capable specialty manufacturers, and pharma ingredient distributors.
- Supplier acceptance hinges on cGMP scope, impurity control consistency, solid-state/salt formation documentation, and regulatory filing support (DMF/CEP claims backed by site documentation).
- Procurement should compare suppliers on file-ability and change-control readiness, not just availability and price.
FAQs
1) Is dihydroergotamine mesylate sourced more often as a direct API or via free base conversion?
It is typically sourced either as a direct API salt from API manufacturers or through salt-forming conversion supported by validated processes at capable chemical manufacturers. Distributor offers must reveal the manufacturer of record to determine which route applies.
2) What quality attributes matter most for DEM mesylate?
The critical attributes are identity, assay, related substances/impurity profile, salt form consistency, residual solvents (if relevant), and packaging with stability support.
3) How do suppliers usually handle regulatory paperwork for DEM?
Acceptable suppliers provide a COA per batch plus GMP documentation for the manufacturing site. Where filing support is claimed, DMF/CEP references are used with consistent impurity and specification narratives.
4) What is the biggest procurement failure mode for DEM?
Buying non-file-able material. The material may be “available,” but lacks cGMP scope, stable impurity control, or solid-state/salt documentation needed for downstream regulatory work.
5) Do distributors differ meaningfully from API manufacturers for DEM sourcing?
Yes. Distributors can provide faster access but the manufacturer of record drives quality and regulatory readiness. Procurement should demand the manufacturer-of-record identity and batch documentation traceability.
References
[1] European Medicines Agency. (n.d.). Public assessment reports and regulatory documents related to dihydroergotamine and ergot alkaloid products. European Medicines Agency. https://www.ema.europa.eu/
[2] US Food and Drug Administration. (n.d.). Drug approvals and drug database resources. FDA. https://www.fda.gov/drugs
[3] World Health Organization. (n.d.). Quality assurance of pharmaceuticals: standards and guidance. WHO. https://www.who.int/teams/regulation-prequalification/quality-assurance
[4] European Pharmacopoeia. (n.d.). Monographs for dihydroergotamine-related substances and salts (where applicable). European Directorate for the Quality of Medicines & HealthCare. https://www.edqm.eu/
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