Last updated: June 1, 2026
Perseris Kit (risperidone) is supplied through a defined manufacturing and supply chain that includes at least (i) the drug substance supply for risperidone, (ii) the drug product manufacturing for the extended-release risperidone microspheres and the prefilled injection components, and (iii) kit and packaging operations supporting the marketed “kit” configuration sold to wholesalers and healthcare providers. The branded product is marketed by Independence Pharmaceuticals, Inc. (US).
Who are the suppliers for Perseris Kit (risperidone extended-release microspheres)?
Answer: The Perseris supply chain comprises (1) risperidone active pharmaceutical ingredient (API) manufacturers, (2) manufacturers of the extended-release risperidone microsphere drug product and its prefilled injection components, and (3) companies that perform kit assembly/labeling and distribution to the US channel.
Because “Suppliers” in pharma typically includes multiple tiers (API, drug product, kit assembly, packaging, and distribution), the supplier universe for Perseris must be mapped by function. The most defensible supplier list is the set of companies named on regulatory filings (FDA submissions and labeling/inspecting data), the facilities appearing as manufacturers in the approved labeling, and the logistics/distribution parties used for US commercialization.
What suppliers typically exist for a Perseris-style kit
- API manufacturer(s): produces risperidone used to form microspheres.
- Drug product manufacturer(s): produces extended-release risperidone microsphere suspension and injection-ready components.
- Prefilled device and fill-finish operations: responsible for filling, sealing, and assembly of injection components.
- Kit assembly and packaging: puts components into the “kit” configuration, applies labels, and prepares for distribution.
Which company supplies Perseris in the US market?
Answer: Independence Pharmaceuticals, Inc. markets Perseris in the United States under the branded product name “Perseris kit.”
How marketing authorization maps to supplier roles
- Marketing authorization holder / label holder: Independence Pharmaceuticals, Inc.
- Actual supply: performed by manufacturing and packaging operations named in FDA product/label information for Perseris and inspected under cGMP.
What manufacturing sites produce Perseris Kit for injection?
Answer: Perseris is produced as an extended-release risperidone microsphere injectable kit; manufacturing is performed at one or more cGMP drug product and fill-finish sites that make the microspheres and injection components.
Drug product and kit component manufacturing
- Extended-release microspheres: formed from risperidone and excipients, then packaged into injection components.
- Injection assembly: includes the sterile components needed for administration as a kit.
Does Perseris require a kit assembler supplier (packaging and labeling)?
Answer: Yes. Perseris is marketed as a “kit,” and kits in the injectable space generally undergo kit configuration, labeling, and packaging operations at designated cGMP/packaging facilities prior to distribution.
Kit assembly supplier functions
- Combine required injection components
- Apply US labels (NDC-level packaging)
- Assemble the finished kit for wholesale distribution
Who supplies risperidone API used in Perseris?
Answer: Perseris uses risperidone as the active ingredient; API sourcing is typically performed by specialized chemical manufacturers. The named API suppliers for Perseris are the API manufacturers identified in FDA submissions or the manufacturing section of the approved labeling and are the only supplier list that is litigation- and diligence-grade.
API sourcing in extended-release microsphere products
Risperidone used in a microsphere product is usually a high-quality API with defined impurity profiles and particle/grade specifications suitable for controlled-release manufacturing.
Which suppliers handle distribution of Perseris in the US?
Answer: Distribution is handled through the US wholesale channel by authorized distributors after final release. The parties involved depend on the wholesaler network and distribution agreements used by the label holder and its logistics providers.
Distribution vs manufacturing
- Manufacturing and packaging providers create and release product under cGMP.
- Distributors move the released product into the healthcare supply chain.
How to confirm the Perseris supplier list for due diligence
Answer: Use the manufacturer listings in FDA-approved labeling and regulatory submissions tied to the product’s dosage form and NDC package configuration.
Where supplier names should appear
- Approved prescribing information: “Manufactured for” / manufacturer and packaging lines
- FDA database records tied to the drug product
- FDA CMC and inspection-related facility listings
What supplier set matters most for licensing or litigation involving Perseris?
Answer: For IP and regulatory risk, diligence targets the suppliers that control manufacturing processes and formulation-critical operations:
- Microsphere drug product manufacturing site(s)
- Sterile fill-finish/assembly site(s)
- Kit assembly/packaging site(s) and labeling control
Why kit assembly suppliers matter
In kit products, packaging and configuration can affect:
- product handling and stability
- packaging-level labeling compliance
- chain-of-identity for regulatory and enforcement actions
Key Takeaways
- Perseris Kit is supplied through a multi-tier chain: risperidone API, extended-release microsphere drug product manufacturing, injection component fill-finish, and kit assembly/packaging.
- Independence Pharmaceuticals, Inc. is the US label holder/marketer for Perseris.
- The most reliable supplier list for business, regulatory, or litigation use is the set of manufacturing, kit packaging, and label/make operations shown in FDA-approved product information.
FAQs
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Who is the label holder for Perseris kit in the US?
Independence Pharmaceuticals, Inc.
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What types of suppliers provide Perseris kit components?
API suppliers, microsphere drug product manufacturers, sterile fill-finish/injection component suppliers, and kit assembly/packaging suppliers.
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Do suppliers for Perseris kit differ from those for risperidone tablets?
Yes. Extended-release injectable microsphere products use different formulation and manufacturing/fill-finish supply chains than oral dosage forms.
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What supplier operations are most important for regulatory compliance in Perseris kit?
Microsphere manufacture, sterile injection component fill-finish, and kit assembly/labeling.
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How can buyers verify Perseris kit suppliers quickly?
By checking the manufacturer and packaging information in FDA-approved labeling tied to the specific Perseris kit package/NDC.
References (APA)
- US Food and Drug Administration. Perseris (risperidone) prescribing information and product labeling.
