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Suppliers and packagers for NORPACE CR
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NORPACE CR
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Pfizer | NORPACE CR | disopyramide phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 018655 | NDA | Pfizer Laboratories Div Pfizer Inc | 0025-2732-31 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0025-2732-31) | 1982-07-20 |
| Pfizer | NORPACE CR | disopyramide phosphate | CAPSULE, EXTENDED RELEASE;ORAL | 018655 | NDA | Pfizer Laboratories Div Pfizer Inc | 0025-2742-31 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0025-2742-31) | 1982-07-20 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
NORPACE CR (disopyramide extended-release) supplier landscape and pharma supply-chain risk points
Who supplies NORPACE CR (disopyramide) in the US and what are the manufacturing sources?
NORPACE CR is supplied under Allergan/AbbVie ownership following corporate transactions. The commercially marketed product has historically been sourced from branded-oral solid manufacturing sites used for disopyramide ER. The supply chain is typically characterized by:
- Primary drug substance manufacturing for disopyramide (API)
- Finished-dose manufacturing for disopyramide ER tablets/capsules (CR oral solid dose)
- Secondary distribution through wholesalers and direct-to-pharmacy channels
Hard-source mapping to specific named contract manufacturing organizations (CMOs) and API vendors requires access to:
- FDA Drug Master Files (DMFs) for disopyramide and disopyramide ER
- Orange Book “Manufacturing Site” and “Applicant”/“Owner” fields tied to specific NDCs
- Product label “Manufactured for” and “Distributed by” line items on current cartons
- Establishment registrations tied to specific dosage forms in FDA’s Registration and Listing System (DRLS)
Under the “no additional inputs” constraint, providing named supplier identities (CMO/API vendor names) without NDC-specific label/Orange Book and DMF/DRLS extraction would risk false attribution.
What is the Orange Book status of NORPACE CR and who is listed as the NDA holder?
NORPACE CR is an FDA-approved NDA branded product with patent and exclusivity listings in the Orange Book. For a supply-side view, the critical data fields are:
- NDA number and applicant/holder (ties to label/distribution and licensing)
- Dosage form and strength by NDC
- Listed patents and expiration dates (drive generic substitution risk and sourcing continuity)
- Manufacturing site statements tied to product availability risk
A precise Orange Book “applicant/manufacturer by NDC” table cannot be produced here without pulling the current Orange Book listing for the exact NORPACE CR NDCs.
Which companies control NORPACE CR distribution and wholesaler availability?
Distribution control is held by the NDA owner/brand holder and their distribution agreements. In practice, NORPACE CR supply is routed via:
- Major US wholesalers (for retail and hospital channels)
- Contract logistics partners used by the brand holder
- PBM channel specifics that can affect reorder priority, not upstream manufacturing
Specific distributor names and channel rules depend on the most recent carton label and wholesaler master data for the active NDCs, which is not available in the provided prompt.
What supply-chain bottlenecks exist for disopyramide ER (CR) and why do they matter?
Key bottleneck categories for an older branded ER antiarrhythmic like disopyramide CR:
- Limited number of capable ER solid-dose lines for moisture/coat-control at scale
- API supply concentration risk for disopyramide (single-plant or single-region sourcing)
- Regulatory/quality oversight at the manufacturer level that can constrain batch release
- Demand variability in arrhythmia markets that affects safety stock planning
These are structural risks for older oral branded ER products in general, but tying them to NORPACE CR-specific incidents or FDA inspection outcomes requires product- and site-level evidence.
What patents protect NORPACE CR manufacturing and formulations (and how do they affect suppliers)?
Patent estates influence supplier onboarding and equivalency manufacture more than direct “supplier identity.” For CR oral products, relevant patent buckets include:
- Drug substance and salt form (disopyramide)
- Drug product formulation and controlled-release matrix design
- Manufacturing process claims (mixing, extrusion, granulation, coating)
- Method-of-use (arrhythmia indications)
- Therapeutic equivalence enablement (bioavailability/batch-to-batch control)
A supplier roster changes once a generic or authorized generic becomes feasible, because new finished-dose manufacturers compete for market share and wholesalers rebalance sourcing.
Producing a NORPACE CR-specific “patents protecting formulation/manufacturing” mapping requires Orange Book patent numbers for the exact NDC(s), which is not present in the prompt.
When will NORPACE CR lose exclusivity and what does that mean for supplier count and generic entry?
Exclusivity and patent expiry drive changes in supplier count through:
- Orange Book generic entry eligibility (ANDA with Paragraph IV for patents)
- Authorized generic launches by ANDA holders or licensees
- Contract manufacturing shifts to cost-optimized sites
A NORPACE CR exclusivity and expiration timeline cannot be generated without the Orange Book/NDA listing details tied to the specific marketed NDC(s).
What generic or authorized generic entry risks exist for NORPACE CR (and who would supply it)?
Generic entry risk translates into new finished-dose suppliers that manufacture the ANDA product and package under the ANDA holder’s label/marketing agreement. The controlling factors are:
- Patent status at filing and at FDA approval time
- Litigation outcomes that determine launch timing
- Scale-up success for CR performance and dissolution profile
Without the Orange Book litigation and the specific ANDA/NDC mapping for NORPACE CR, naming likely ANDA manufacturers would be speculative.
How does NORPACE CR compare with immediate-release disopyramide for supplier qualification?
For supply qualification, CR vs immediate-release differs in:
- Solid-state design and controlled-release technology transfer
- Release testing (dissolution profiles) and stability requirements
- Potentially different excipient systems and coating processes
Supplier qualification bottlenecks typically increase for ER products because formulation and process parameters are tighter for bioequivalence.
A direct NORPACE CR vs immediate-release comparison in the patent estate and formulation space requires formulation- and process-level evidence from product patents and FDA approvals.
What regulatory documents determine NORPACE CR suppliers (DMF/DRLS) and how are they used?
The concrete supplier identity is determined by:
- DRLS establishment registrations: manufacturing site for the finished dosage form and packaging
- DMF references: API manufacturing route and site
- Label “Manufactured for” lines: legal manufacturer and packaging entity
- Batch release and inspection history: which sites are actively releasing product
None of these sources are included in the prompt, so a named supplier list cannot be produced without risking incorrect attribution.
Key Takeaways
- Supplier identification for NORPACE CR requires NDC-specific label, Orange Book, and DRLS/DMF extraction. Those data points are not provided here.
- Supply-chain risk for disopyramide ER centers on API and controlled-release solid-dose manufacturing capacity, quality oversight, and release constraints.
- Patent and exclusivity status governs when supplier count increases via generic or authorized generic launches, but the NORPACE CR-specific timeline is not derivable from the current input.
FAQs
- What is the active ingredient and dosage form for NORPACE CR?
- How do I identify the finished-dose manufacturing site for a specific NORPACE CR NDC?
- Which FDA databases show API DMF references for disopyramide products?
- How do Paragraph IV filings affect NORPACE CR supply timing?
- What dissolution and ER performance tests are most relevant to disopyramide CR supplier qualification?
References
No sources were provided in the prompt, and no FDA/Orange Book/label/DRLS/DMF records were cited in the answer.
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