Last updated: May 28, 2026
Metyrapone Suppliers: Who Manufactures and Distributes Metopirone (Metyrapone) APIs, Drug Product, and Generics?
Metyrapone is a specialized, older endocrine drug with a limited supplier base. Current commercial availability is driven by a small set of manufacturers across the US and EU, with import dependence for brand and bulk API.
Core sourcing lanes
- Drug product suppliers (tablets): branded/authorized holders and wholesalers that maintain US distribution.
- API suppliers: contract manufacturers and API producers supporting tablet manufacturing.
- Compounding/clinical channel: hospital pharmacy and specialty distributors that source from licensed importers or API-to-finished-dose networks.
What companies supply metyrapone tablets in the US supply chain?
Direct drug product availability typically comes from
- Wholesalers and specialty distributors stocking NDC-labeled product sourced from authorized manufacturers.
- Generic/authorized product manufacturers producing metyrapone tablets for the market.
Because metyrapone is not a high-volume modern blockbuster, supplier concentration is higher than for large-scale CNS or oncology products. Procurement usually requires confirmation through wholesaler inventory systems or NDC-level sourcing.
Which NDC-labeled metyrapone products dominate US distribution?
- Identify the active NDC(s) linked to metyrapone tablets and map each to the labeler/firm and manufacturer of record listed in FDA drug listings.
- Cross-check each labeler firm against CGMP inspection coverage and site manufacturing authorization.
How do wholesalers source metyrapone when local manufacturing is limited?
- Common models:
- Manufacturer-to-wholesaler distribution with allocation.
- Importer-led channel replenishing US stock.
- Specialty distributor procurement via short lead-time orders.
Who supplies metyrapone API (bulk drug substance) for contract manufacturing?
API sourcing for metyrapone is constrained by
- Synthetic capability for an older steroidogenesis inhibitor scaffold.
- Regulatory maintenance and batch release capacity.
- Ability to supply DMF-backed or otherwise qualified documentation for finished dose manufacture.
Which API suppliers are most likely active in metyrapone upstream production?
In practice, metyrapone API sourcing tends to come from:
- Experienced hormone/endocrine API contract manufacturers.
- Specialty API plants with capacity for nitro-and steroid-like fragment chemistries and controlled impurity profiles.
- Regional importers if domestic capacity is inactive.
A procurement-grade supplier list must be built from:
- FDA DMF filings tied to metyrapone.
- EU CEP or manufacturer-of-record documentation.
- Finished dose manufacturer qualification of API suppliers through audit packages.
What is the Orange Book status of metyrapone and how does it affect supplier availability?
Orange Book listing presence affects competition and supply resilience.
- If metyrapone is listed with patents (or exclusivity), it tends to have fewer generic entrants.
- If it is not listed for many years, procurement can still be limited due to low demand rather than IP.
Does Orange Book exclusivity reduce the number of suppliers?
- Low demand plus historical brand anchoring typically reduces new entrants.
- Even when IP is expired, API economics often prevent additional capacity from coming online.
What do you check for supplier qualification in the Orange Book context?
- The listed active ingredient name and dosage form entries.
- Any listed patents tied to the drug product.
- Whether the product is marketed as RLD or under legacy authorizations.
Which generics compete with metyrapone and what supplier risks exist for generic entry?
Supplier risk profile for metyrapone is driven by
- Low market size.
- Strict quality and impurity controls typical for specialized endocrine drugs.
- Batch release timing and documentation completeness.
What generic entry risks exist for metyrapone tablets?
- Limited incentives lead to:
- Fewer ANDA filers.
- Long gaps between manufacturing site runs.
- Dependence on single API sources.
How can supply disruption occur even without active patent barriers?
- API interruption, regulatory inspection outcomes, or plant conversion can stop finished dose runs.
- Finished dose manufacturers may shift to alternative products, leaving wholesalers relying on imports.
What manufacturing sites produce metyrapone tablets and how do you identify them?
A high-confidence supplier map relies on tying together three layers:
- Labeler/firm on the NDC.
- Manufacturer of record on FDA drug listing.
- Site manufacturing tied to CGMP inspection history and DMF/ANDA references.
How to build a site-level supplier roster (procurement-ready)
- Start from NDC labeler.
- Pull “manufacturer” and “packager” fields from FDA drug listing records.
- Validate each site’s documented capability for:
- the same dosage strength
- tablet form factor
- impurity range expectations and stability profile
How does metyrapone compare with similar steroidogenesis inhibitors in terms of supplier breadth?
Metyrapone sits in the class of adrenocortical steroidogenesis inhibitors. Compared with higher-demand modern endocrine agents, supplier breadth is smaller due to limited global use.
Which comparable drugs show similar supply consolidation patterns?
- Older adrenal steroidogenesis inhibitors and niche endocrinology agents often show:
- fewer finish-dose suppliers
- reliance on a small API base
- seasonal or batch-driven availability
Regulatory and documentation: what supplier files matter for metyrapone procurement?
For procurement and compliance, supplier selection usually hinges on documentation availability:
- DMF/ASMF linkages for API traceability.
- GMP compliance and inspection classification.
- COA frequency and impurity monitoring history.
- Stability and shelf-life data consistent with distribution timelines.
What to request from metyrapone suppliers
- Certificate of Analysis for current lots.
- Impurity specification and test methods alignment to the intended finished-dose use.
- Evidence of regulatory standing for the manufacturing site.
Key Takeaways
- Metyrapone suppliers are concentrated due to limited demand and specialized manufacturing requirements.
- Procurement typically depends on a small set of drug-product manufacturers plus upstream API producers.
- The fastest way to operationalize sourcing is to build the roster from NDC labelers/manufacturers and validate upstream API/DMF linkages.
- Supplier continuity risk is often economics and plant scheduling, not only IP.
FAQs
- How do I identify the manufacturer of record for metyrapone tablets by NDC?
- What API documentation (DMF/ASMF) is typically required to qualify a metyrapone API supplier?
- Why can metyrapone be intermittently unavailable even when tablets are FDA-listed?
- What supply-chain checks reduce the risk of counterfeit or mislabeled metyrapone product?
- How do you compare the impurity profiles of metyrapone lots across different API sources?
References
- FDA. (n.d.). Drug listings and NDC directory (Metyrapone). FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
- FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA. https://www.accessdata.fda.gov/scripts/cder/ob/
