Suppliers and packagers for LYSODREN

LYSODREN

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Esteve	LYSODREN	mitotane	TABLET;ORAL	016885	NDA	ESTEVE PHARMACEUTICALS, S.A.	68118-080-60	1 BOTTLE in 1 CARTON (68118-080-60) / 100 TABLET in 1 BOTTLE	1978-10-15
Esteve	LYSODREN	mitotane	TABLET;ORAL	016885	NDA	HRA Pharma Rare Diseases	76336-080-60	1 BOTTLE in 1 CARTON (76336-080-60) / 100 TABLET in 1 BOTTLE	1978-10-15

Suppliers and packagers for LYSODREN

Last updated: May 31, 2026

Lysodren (mitotane) suppliers: who manufactures, licenses, and sells the drug by geography

Lysodren is mitotane (o,p’-DDD), an adrenocortical carcinoma drug with a narrow global manufacturing footprint. Commercial supply in each market depends on the product’s marketing authorization holder and the actual manufacturer of record for the finished dosage form (tablets). Without market-specific regulatory and label data for each country, a complete, accurate supplier list cannot be produced.

What companies supply Lysodren (mitotane) tablets in the US and EU?

Featured-snippet answer: Lysodren supply is tied to the marketing authorization holder and the finished-dose manufacturer listed on the local product dossier; mitotane bulk and intermediate suppliers can differ from the tablet manufacturer.

Where to identify the “supplier” in regulatory terms

For pharmaceutical supply decisions, “supplier” typically means one of three entities:

• Marketing authorization holder (MAH) for the branded product
• Manufacturer of the finished drug product (tablets), listed on the label/regulatory dossier
• Manufacturer of mitotane API and key intermediates, which is often less visible publicly

Why US and EU supplier lists are not interchangeable

• US labels (FDA) and EU EPAR/SmPC vary by MAH over time.
• Contract manufacturing and batch release sites can change without changing the MAH.
• Packaging and distribution chains differ by wholesaler networks.

What is the Orange Book status of Lysodren and what does it imply for supplier risk?

Featured-snippet answer: Orange Book listings apply only to approved, rated drug products in the US that are covered by patent and exclusivity mechanisms; they do not directly enumerate upstream manufacturing suppliers.

Supplier risk implications for Lysodren

• If the product is technically single-source in a market, shortages are more likely when batch releases slip.
• Patent or exclusivity status can limit generic tablet availability, increasing reliance on the branded supply chain.

Which generic or authorized alternatives to Lysodren affect current supplier demand?

Featured-snippet answer: Competition (or lack of it) affects supplier allocations, but it does not identify the manufacturing supplier by itself.

Demand-side effects

• If there are few or no interchangeable alternatives, suppliers for Lysodren capture a larger share of hospital and oncology pharmacy purchasing volume.
• In scarce supply periods, allocation policies can shift purchasing across distributors.

How does mitotane API sourcing work for Lysodren tablets?

Featured-snippet answer: API supply can come from different chemistry routes and vendors than the finished-dose manufacturer, but public records do not reliably expose all API vendors.

Typical supply chain structure for specialty oncology drugs

• API synthesis and purification (multiple potential contract API manufacturers)
• Tablet formulation and compression (finished-dose manufacturer)
• Batch release testing and packaging (may be split across sites)

What manufacturing site and batch-release controls apply to Lysodren?

Featured-snippet answer: Batch release and quality testing follow GMP plus local regulatory requirements for the dosage form.

Key operational points

• Compliance for potent oncology drugs includes validated assay, impurity profiling, and stability-indicating methods.
• Finished-dose manufacturing controls can be a bottleneck even if API is available.

What patent estate issues change supplier availability for Lysodren?

Featured-snippet answer: Patent and exclusivity can restrict generic entry, keeping supply concentrated with the branded manufacturer.

How patent duration maps to supplier continuity

• Longer exclusivity keeps generics off-market
• Entering generics may change supply dynamics, but this depends on regulatory approvals and launch execution

What generic entry risks exist for mitotane (o,p’-DDD) tablets?

Featured-snippet answer: Generic entry risk is mainly driven by whether an abbreviated approval pathway is viable and whether stability and impurity specifications can be met at scale.

Where risk typically shows up

• Bioequivalence requirements for oral tablets
• Impurity profile matching for a complex active ingredient
• Scale-up and consistent potency assay across batches

Key Takeaways

• “Supplier for Lysodren” depends on the definition used: MAH, finished-dose manufacturer, or API vendor.
• Public data sources that identify finished-dose manufacturers are market- and time-specific; a complete cross-market supplier list cannot be assembled without product-by-country regulatory label and dossier evidence.
• Supply concentration for specialty mitotane generally increases shortage sensitivity when manufacturing or batch release capacity tightens.

FAQs

1. Who is the marketing authorization holder for Lysodren in my country?
2. Which company manufactures Lysodren tablets versus who supplies mitotane API?
3. Does Orange Book information for mitotane list manufacturing sites or only legal listings?
4. How do shortages of mitotane affect hospital purchasing and distributor allocation?
5. What signals indicate a change in Lysodren manufacturing site or batch release location?

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.
2. European Medicines Agency. EPARs and product information for mitotane-containing medicines. EMA.