Last updated: June 6, 2026
OPIPZA suppliers: who manufactures, fills, and supplies the active drug product for this FDA drug
OPIPZA is a branded opioid product. Supplier mapping requires FDA product-specific data (Orange Book and FDA labeling manufacturing information), plus commercial supply-chain disclosures. No complete, verifiable supplier list can be produced from the information provided.
Who supplies OPIPZA (manufacturers, contract manufacturers, and packagers)?
Featured snippet answer: A complete supplier list for OPIPZA cannot be stated from the provided prompt.
What supplier roles exist in the OPIPZA supply chain?
OPIPZA supply chains typically split into:
- Drug substance (API) manufacturing
- Drug product manufacturing (tablets/capsules/solution fill-finish depending on dosage form)
- Quality control release testing
- Packaging and labeling
- Wholesaling and distribution through FDA-registered distributors
Where do OPIPZA supplier identities come from in practice?
- FDA Orange Book “Applicant” and listed patents link to marketing authorization holders
- FDA labeling “Manufactured for” and “Distributed by” sections list labeled suppliers
- FDA establishment registration data identifies manufacturing sites (but not always who “owns” commercial supply)
- Contract Manufacturing Organization (CMO) disclosures appear in labeling and inspection histories
What does OPIPZA’s FDA label say about manufacturers and distributors?
Featured snippet answer: The provided prompt does not include OPIPZA labeling text or the FDA label “Manufactured for” lines needed to identify specific suppliers.
Which label fields typically identify suppliers?
- “Manufactured for” (marketing authorization holder and labeled manufacturer)
- “Manufactured by” (site-specific manufacturer name/address)
- “Distributed by” (wholesaler/distributor name)
- Packaging imprint and NDC labeling statements (often site-level traceability)
What is the Orange Book status of OPIPZA and how does it map to suppliers?
Featured snippet answer: Orange Book supplier mapping cannot be completed without the Orange Book entry for OPIPZA (applicant, dosage form, strength, and listed product identifiers).
Which Orange Book fields drive supplier identification?
- Application number (NDA/BLA)
- “Applicant” and “Manufacturer” fields tied to the drug product
- Patent linkage that helps confirm the marketing authorization holder
Which companies make OPIPZA for the market?
Featured snippet answer: A company list cannot be produced from the provided prompt.
Common supplier categories you would expect to see
- Marketing authorization holder (brand owner)
- Listed NDA applicant and labeled manufacturer
- API supplier(s) behind the drug substance
- CMO(s) for compression/coating/sterile fill-finish, depending on formulation
How do contract manufacturers and API suppliers for OPIPZA differ by site and dosage form?
Featured snippet answer: Site-level and dosage-form-specific supplier differences cannot be established without the exact OPIPZA NDC set and labeling manufacturing statements.
Key differences that matter for procurement and legal diligence
- Same brand, multiple NDCs can map to different manufacturing sites
- API supply can be sourced from different suppliers over time
- Sterile vs non-sterile processes change the set of qualified suppliers
What is the licensing or partnership footprint behind OPIPZA supply?
Featured snippet answer: The prompt does not include any licensing agreement or corporate transaction data.
Where partnerships show up
- NDA transfers in FDA systems
- “Manufactured for” changes across label revisions
- Public filings tied to brand licensing or manufacturing outsourcing
What supplier risks exist for OPIPZA (single-site dependence, substitution, and continuity)?
Featured snippet answer: Risk analysis cannot be completed without identifying OPIPZA’s actual manufacturing and distribution entities.
Supplier risk factors typically used in diligence
- Single-site manufacturing for the commercial dosage form
- Regulatory history of manufacturing site (FDA inspections)
- Dependence on a single API supplier
- Limited secondary packaging capacity
Key Takeaways
- A complete, verifiable list of OPIPZA suppliers (manufacturers, CMOs, packagers, distributors, and API sources) cannot be produced from the information provided.
- Supplier identification requires OPIPZA-specific FDA labeling and Orange Book establishment/applicant data, matched to NDC(s) and dosage form(s).
FAQs
- How can I identify the manufacturer listed on OPIPZA packaging?
- Does OPIPZA have multiple NDCs with different manufacturing sites?
- Who is the Orange Book applicant for OPIPZA and what does that imply for suppliers?
- Are OPIPZA’s API suppliers named on the FDA label?
- Which FDA databases show establishment registration for OPIPZA manufacturing sites?
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Database).
- FDA. Drug Label Information (DailyMed). (Database).
