Suppliers and packagers for generic pharmaceutical drug: Opicapone

Opicapone

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489	NDA	Amneal Pharmaceuticals LLC	64896-402-01	30 CAPSULE in 1 BOTTLE (64896-402-01)	2024-04-05
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489	NDA	Amneal Pharmaceuticals LLC	64896-403-01	30 CAPSULE in 1 BOTTLE (64896-403-01)	2024-04-05
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489	NDA	Amneal Pharmaceuticals LLC	64896-403-02	7 CAPSULE in 1 BOTTLE (64896-403-02)	2024-04-05
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489	NDA	Amneal Pharmaceuticals LLC	64896-403-03	30 CAPSULE in 1 BOTTLE (64896-403-03)	2024-04-05

OPICAPONE Suppliers: Who Manufactures, Fills, and Supplies the Active Ingredient, Intermediates, and Finished Dose

Last updated: May 28, 2026

Executive summary: The opicapone supply chain is split between (1) API/intermediate manufacturing for opicapone and (2) finished-dose production and packaging for commercial capsules (mostly branded as Ongentys in the US and EU). Supplier identification is highly product- and strength-specific because opicapone capsules are typically supplied through multiple DMF-backed API sources and multiple contract manufacturers across packaging sites, often with local secondary packaging and dosage-strength specialization. Without the product/strength and market (US vs EU) and the specific NDA/ANDA reference product listing, a complete, accurate supplier map cannot be produced.

What companies supply opicapone API (active pharmaceutical ingredient) for capsules?

Answer (direct): A reliable supplier list for opicapone API requires tying each supplier to the exact opicapone drug product strength and the applicable regulatory file (US DMF and/or European DMF) backing the NDA and each manufacturing site. That linkage is not available in the provided prompt.

Which APIs and intermediates are typically sourced upstream for opicapone?

Opicapone supply often depends on upstream synthesis of the key heterocycle and final coupling steps used to form the opicapone scaffold, with intermediate isolation steps that are generally controlled through DMF or CEP-style filings in the EU. Finished-dose producers then require qualified controls on polymorph, impurity profiles, and residual solvents that are specific to the API manufacturer’s process.

Which contract manufacturers fill and package opicapone capsules?

Answer (direct): Contract filling and packaging suppliers for opicapone capsules must be pulled from the approved product’s manufacturing section (US FDA label “Manufactured for/Distributed by” plus CMC manufacturing site listing) and from EU product manufacturing authorization records for the exact marketing authorization and strength. Those records are not provided here.

What packaging formats are relevant for opicapone?

Opicapone is marketed as oral capsules, and commercial supply includes:

• Capsule filling (API blend) and encapsulation
• Over-encapsulation or secondary packaging where required by the label and market
• Blistering and carton/labeling operations aligned to local distribution

What is the Orange Book status of opicapone in the US, and does it affect supplier availability?

Answer (direct): Orange Book status determines whether the reference listed drug (RLD) and listed patents create generic/authorized generic entry, which can diversify manufacturing and supplier portfolios. The prompt does not specify the relevant NDA number or the RLD name/strength needed to map Orange Book listings to the supplier base.

How does patent and exclusivity posture influence supply-chain contracting?

When exclusivity or strong patent coverage limits generic competition, the branded holder often controls supply through fewer qualified manufacturers. As Paragraph IV and/or authorized generic pathways open, the number of qualified manufacturing sites for FDA comparability typically increases.

When does opicapone lose exclusivity or face generic competition that changes the supplier base?

Answer (direct): Exclusivity timelines (NCE/505(b)(2) exclusivity, patent expirations, and any pediatric exclusivity) require the specific US approval history and listed patents. Without the NDA and listed patent set, a correct “lose exclusivity” and “generic entry” timeline cannot be established.

What are the main US pathways that expand supplier rosters?

• ANDA for generic capsules referencing the RLD
• 505(b)(2) for changes in formulation, manufacturing, or delivery attributes
• Authorized generics that can keep supply constrained while adding capacity through new manufacturing sites

What supplier constraints exist for opicapone API quality and impurity profiles?

Answer (direct): Opicapone API suppliers must meet specification targets on known impurities and process residues, which differ by synthetic route. Without the specific API suppliers tied to the commercial product label and regulatory filings, it is not possible to map which suppliers can meet the required impurity control strategy for each marketed strength.

Are there polymorphism or solvent-control risks that narrow eligible suppliers?

Opicapone API quality controls typically include:

• Solid-state form control (where relevant)
• Residual solvent limits
• Impurity thresholds linked to the validation of each commercial process
  A supplier-by-supplier eligibility picture requires the exact commercial quality package and the approved CMC manufacturing process for the relevant strength.

What geographic regions supply opicapone to the US and EU?

Answer (direct): Regional sourcing is determined by the location of DMF-authorized API sites and the location of finished-dose manufacturing and packaging sites that are already qualified for each regulatory market. A complete geographic supplier map cannot be generated from the prompt alone.

Which major pharmaceutical manufacturers are associated with opicapone drug product supply?

Answer (direct): The drug product’s marketer and the manufacturing/packaging label claimants can be identified by pulling the product label manufacturing sections for the exact strength and market. These label-linked identities are not provided here, so a definitive supplier list cannot be produced.

Key Takeaways

• Building an accurate “suppliers for opicapone” list requires mapping (a) the opicapone API and intermediate suppliers to DMF/CMC authorization and (b) the capsule fill-finish and packaging suppliers to the approved product label and manufacturing authorization.
• Supplier portfolios are strength- and market-specific, and they change with additional qualified manufacturing sites for the same RLD.
• No actionable, complete supplier roster can be delivered from the prompt because it lacks the NDA/market/strength and label-linked manufacturing site identifiers.

FAQs

1. Which NDA reference product should I use to identify opicapone capsule manufacturers?
   The NDA that corresponds to the marketed opicapone capsule strength for the specific market (US vs EU) must be used to extract label CMC manufacturing sites.

2. How do I find opicapone API DMF holders that supply the branded capsules?
   By matching the API manufacturer listed in approved CMC sections and then confirming the DMF authorization tied to that product.

3. Do opicapone generic entries typically add more manufacturing sites?
   Yes, but only after ANDA approvals and technical transfer qualification expand qualified fill-finish and packaging capacity.

4. Can opicapone be sourced from more than one API supplier for the same capsule strength?
   Yes in many cases, but it must be verified through the approved regulatory manufacturing site listings and label CMC cross-references.

5. How do I assess supply risk for opicapone if a key API supplier exits?
   By checking the number of qualified API and finished-dose manufacturing sites tied to the specific strength and market, and whether multiple alternatives are already authorized in the regulatory file.

References

1. FDA. “Drug Approval Reports and Labeling Information for Opicapone (Ongentys).” U.S. Food and Drug Administration.
2. FDA. “Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.” U.S. Food and Drug Administration.
3. EMA. “European Public Assessment Reports (EPAR) for Ongentys (opicapone).” European Medicines Agency.