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Suppliers and packagers for generic pharmaceutical drug: OLODATEROL HYDROCHLORIDE
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OLODATEROL 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 |
|---|---|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | STRIVERDI RESPIMAT | olodaterol hydrochloride | SPRAY, METERED;INHALATION | 203108 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0192-61 | 1 CARTRIDGE in 1 CARTON (0597-0192-61) / 60 SPRAY, METERED in 1 CARTRIDGE | 2014-08-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: OLODATEROL HYDROCHLORIDE
Suppliers of Olodaterol Hydrochloride (Raw Material, API, and Contract Manufacturing): Who Makes It and Where Supply Bottlenecks Can Form
Olodaterol hydrochloride is supplied through a small set of specialized API manufacturers and contract development and manufacturing organizations (CDMOs) that support inhalation small-molecule workflows. Supply is typically structured as (1) API merchants selling olodaterol HCl as a chemical intermediate and (2) CDMOs producing inhalation-grade API or drug substance under quality-by-design and inhalation impurity control.
Practical supply map (API vs CDMO)
- API manufacturers: sell olodaterol hydrochloride (or olodaterol HCl drug substance) under commercial supply terms for inhalation products.
- CDMOs / contract API manufacturers: produce olodaterol HCl under development or commercial cGMP for inhalation.
- Inhalation package supply: device and finished-dose manufacturing is separate from olodaterol API supply.
Because olodaterol hydrochloride is a niche API used in branded COPD inhalation therapy, supplier concentration is higher than for primary COPD bronchodilator APIs with broader generic adoption.
Who are the olodaterol hydrochloride API suppliers and contract manufacturers?
Featured supplier classes for olodaterol hydrochloride
- Specialty inhalation API producers (custom or commercial olodaterol HCl drug substance)
- Intermediates-to-API integrated chemical suppliers that manage the synthesis route and impurity profile required for inhalation
- CDMOs with inhalation drug substance capability that support scale-up, analytical methods, and impurity qualification
What to verify in each supplier qualification package
- CEP or DMF status in key markets (EMA and FDA equivalents)
- Sterility and micronization expectations: inhalation APIs require tight specs even when non-sterile
- Impurity control strategy: olodaterol impurity set alignment to the drug product specification
- Polymorph and particle-size impact: although olodaterol HCl is not typically described as a “particle-engineered” API like some excipient systems, inhalation formulations still depend on consistent API physical properties
- Regulatory history: inspection outcomes and prior FDA/EMA filings
Which companies supply olodaterol hydrochloride as a commercial API?
Answer: This depends on current commercial availability because olodaterol hydrochloride is supplied through a limited number of firms and some relationships run through distributors rather than direct sale.
How companies typically show up in market supply
- Global chemical distributors offer olodaterol hydrochloride sourced from regulated API producers.
- Direct-to-industry supply occurs when an API producer has established QA documentation and a DMF or regulatory file that supports inhalation drug substance use.
- CDMO partnerships are common when customers need a tailored grade, impurity profile, or lifecycle support for inhalation products.
Key diligence checkpoints
- Confirm batch release testing scope: identity, assay, water content, specific impurities, residual solvents, and genotoxic impurity controls.
- Confirm commercial lead times: inhalation APIs often have longer ramp-up due to impurity qualification and analytics method transfer.
(Source-based supplier enumeration is not provided here because a complete, accurate supplier list for olodaterol hydrochloride cannot be generated from the information available in this prompt.)
What CDMOs manufacture olodaterol hydrochloride for inhalation drugs?
CDMO selection criteria for olodaterol HCl
- Small-molecule API capability at inhalation-quality scale
- Impurity profiling and regulatory-aligned specs
- Analytical method transfer for the drug substance impurity set and residual solvents
- Route flexibility for scale-up and lifecycle manufacturing stability
Where CDMOs create supply leverage
- When customers require tech transfer + method validation rather than buying finished API.
- When supply risk is driven by single-site API production.
Which suppliers have DMF coverage for olodaterol hydrochloride in the US and EU?
What “DMF coverage” means for suppliers
- US FDA DMF: supports API review for NDA/ANDA drug substance.
- EU CEP / ASMF: supports abbreviated assessment and manufacturer transparency for EMA reviews.
Featured risk for procurement
- Supplier changes can trigger regulatory re-reviews or additional chemistry, manufacturing, and controls updates, which affects launch timing and cost.
How concentrated is olodaterol hydrochloride supply, and what supply bottlenecks matter?
Bottleneck drivers
- Niche API economics: fewer producers can keep continuous commercial supply.
- Impurity qualification effort: inhalation-grade specs raise the cost of switching suppliers.
- Scale-up constraints: olodaterol synthesis routes often require tight solvent and intermediate control.
- Batch-to-batch consistency: physical properties can affect downstream formulation processing.
Procurement implications
- Longer qualification timelines are common for new suppliers.
- Dual-sourcing is harder in small molecule niche APIs unless a customer already maintains a regulatory file.
What is the regulatory and quality dossier supply chain for olodaterol hydrochloride?
Common quality documentation
- CoA with impurity reporting against finished drug substance specs
- GMP manufacturing certificate
- DMF/ASMF alignment: impurity and residual solvent profiles should match regulatory expectations
- Stability program data
Inhalation-specific QA
- Consistency of drug substance quality for aerosolization performance
- Control of trace impurities that can influence tox or safety assessments in inhaled exposure
What inhalation product dependency drives olodaterol hydrochloride procurement?
Downstream linkage
- Olodaterol hydrochloride is used in fixed-dose COPD inhalation products.
- Product launches and lifecycle changes (reformulation, device changes, line extensions) can change the required API quality attributes and supplier qualification status.
Procurement outcome
- API sourcing often locks to suppliers that already support a specific inhalation formulation pathway.
How does olodaterol hydrochloride sourcing compare with tiotropium and other COPD inhalation APIs?
Relative supply structure
- Olodaterol HCl tends to have more concentrated supplier bases than broad COPD APIs with higher generic volume.
- Tiotropium has extensive supplier ecosystems due to multiple marketed generics and biosimilar-like competition dynamics (though tiotropium is a small molecule).
- Olodaterol’s smaller generic footprint usually means fewer fully qualified alternatives.
Procurement implication
- Switching costs are typically higher for olodaterol hydrochloride, especially when a customer needs tight inhalation specs and rapid regulatory alignment.
What patent and exclusivity issues affect olodaterol hydrochloride supply and generic entry?
Procurement impact of IP
- When products are under active patent protection, API suppliers may be constrained by customer qualification requirements and by restrictions tied to manufacturing know-how.
- For generic or follow-on inhalation products, suppliers often need to mirror validated processes and impurity specs tied to the approved dossier.
Commercial effect
- Even when API manufacturing is feasible, regulatory and IP-aligned manufacturing can delay qualification of new suppliers.
(This section addresses the procurement linkage; it does not list patents because a specific product, route, and market authorization set is not provided in the prompt.)
Key Takeaways
- Olodaterol hydrochloride supply is concentrated relative to high-volume COPD APIs, driven by inhalation-grade quality expectations and niche economics.
- Supplier qualification is dossier-critical: procurement should anchor on DMF/ASMF alignment, impurity sets, and inhalation-grade physical property control.
- CDMOs matter when customers need tech transfer, impurity refinement, or a second source to reduce supply risk.
- Switching suppliers is slow due to impurity qualification and regulatory re-alignment requirements.
FAQs
- Do distributors sell olodaterol hydrochloride with the same regulatory documentation as direct API suppliers?
- What specifications matter most for inhalation API sourcing of olodaterol HCl?
- How long does it typically take to qualify a new olodaterol hydrochloride supplier for an inhalation product?
- Is olodaterol hydrochloride sourced primarily as drug substance or as chemical intermediate-to-API in contract deals?
- What are the main manufacturing risks when changing olodaterol hydrochloride API sites (analytical and impurity drift)?
References
No sources were provided in the prompt to cite for a factual supplier list.
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