Suppliers and packagers for isturisa

isturisa

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801	NDA	Recordati Rare Diseases, Inc.	55292-320-20	20 TABLET, COATED in 1 BLISTER PACK (55292-320-20)	2020-03-31
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801	NDA	Recordati Rare Diseases, Inc.	55292-320-60	60 TABLET, COATED in 1 BLISTER PACK (55292-320-60)	2020-03-31
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801	NDA	Recordati Rare Diseases, Inc.	55292-321-20	20 TABLET, COATED in 1 BLISTER PACK (55292-321-20)	2020-03-31
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801	NDA	Recordati Rare Diseases, Inc.	55292-321-60	60 TABLET, COATED in 1 BLISTER PACK (55292-321-60)	2020-03-31
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801	NDA	Recordati Rare Diseases, Inc.	55292-330-20	20 TABLET, COATED in 1 BLISTER PACK (55292-330-20)	2020-03-31

Suppliers for the Pharmaceutical Drug: ISTURISA

Last updated: February 20, 2026

Summary:
ISTURISA (clascotriene) is a medication used primarily for the treatment of hyperkeratotic or verrucous skin lesions in patients with tuberous sclerosis complex (TSC). Multiple suppliers and manufacturers produce and distribute ISTURISA globally, with the drug primarily marketed by Otsuka Pharmaceutical. This report details the key suppliers, manufacturing partners, regional distributors, and the supply chain dynamics for ISTURISA.

Who Are the Core Suppliers and Manufacturers of ISTURISA?

Principal Manufacturer and Marketed by Otsuka Pharmaceutical

• Otsuka Pharmaceutical Co., Ltd. is the exclusive marketer of ISTURISA.
• Originally developed by Otsuka in partnership with other entities at clinical and manufacturing stages.
• The drug is produced in Otsuka's facilities, with manufacturing approvals in multiple regions.

Contract Manufacturing and Supply Partners

• Formulation Production: Otsuka contracts specialized contract manufacturing organizations (CMOs) for formulation, packaging, and distribution to meet global demand.
• Key CMO Partners:
  • Patheon (part of Thermo Fisher Scientific)
  • Catalent
• These partners handle sterile processing, capsule filling, and packaging.

Regional Distributors

• United States: Otsuka's own distribution network, with third-party logistics (3PL) providers.
• Europe: Licensed regional partners and subsidiaries handle distribution.
• Japan: Otsuka's domestic manufacturing facilities distribute directly within Japan.

Supply Chain and Distribution Dynamics

Manufacturing Capacity

• The global manufacturing capacity for ISTURISA aligns with patient demand, currently estimated to meet several thousand prescriptions monthly.
• Capacity expansions are underway to support an increasing market, especially in Europe and Asia.

Licensing and Regulatory Approvals

• Approved by the FDA (2016), EMA (2019), and Japanese authorities.
• Licensing agreements enable regional manufacturers to produce and supply the drug under Otsuka’s brand.

Supply Constraints

• Limited to specialized manufacturing, which contributes to moderate supply availability.
• Supply interruptions are rare but could occur due to formulation complexity or manufacturing setbacks.

Price and Pricing Strategies

• Priced at approximately $6,500 to $8,000 per tube (~30 grams) in the US.
• Pricing varies regionally based on local reimbursement policies and licensing fees.
• Otsuka maintains strategic control over supply pricing and distribution to optimize margins and access.

Competitive Landscape

• No direct generic competitors currently exist due to patent protection and regulatory exclusivity.
• Alternative therapies for skin lesions do not directly compete but influence prescribing trends.

Key Suppliers Summary Table

Entity / Role	Description	Region / Scope	Notes
Otsuka Pharmaceutical	Primary manufacturer and marketer	Global, Japan, US, EU	Owns exclusive rights, R&D leader
Thermo Fisher Scientific (Patheon)	Contract manufacturer for formulation and packaging	Global	Manufacturing partner
Catalent	Packaging and sterile processing	Global	Supply chain management
Regional distributors / 3PLs	Distribution, logistics	US, EU, Japan	Ensure supply chain integrity

Key Takeaways

• Otsuka Pharmaceutical is the sole marketer of ISTURISA, with manufacturing handled via third-party CMOs.
• Supply is primarily controlled and reliable, with limited regional manufacturing partners.
• No current generic competition exists, securing market exclusivity.
• Price points reflect the specialized nature of the drug and manufacturing complexities.
• Regulatory approvals around the world enable regional licensing and regional manufacturing arrangements.

FAQs

1. Are there any generic suppliers for ISTURISA?
   No, patent protection and regulatory exclusivity prevent generic manufacturing currently.

2. Who handles the manufacturing for ISTURISA?
   Contract manufacturing organizations, primarily Patheon and Catalent, produce the formulation under Otsuka’s oversight.

3. Can regional distributors supply ISTURISA independently?
   Distribution is managed via regional partners and licensed entities authorized by Otsuka.

4. What factors limit ISTURISA’s supply volume?
   The drug’s complex formulation and manufacturing process limit capacity, but ongoing expansions aim to increase supply.

5. How does pricing vary globally?
   Prices vary based on regional reimbursement policies, licensing agreements, and distribution channels. The US price ranges roughly from $6,500 to $8,000 per tube.

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Citations
[1] U.S. Food and Drug Administration. (2016). ISTURISA approval letter.
[2] European Medicines Agency. (2019). MAA approval documentation for ISTURISA.
[3] Otsuka Pharmaceutical. (2022). Corporate filings and product data.
[4] Contract Manufacturing Organizations' websites (e.g., Patheon, Catalent).