Last updated: May 30, 2026
Polocaine-MPF suppliers: who manufactures Polocaine-MPF and related bupivacaine MPF products?
Polocaine-MPF is an injectable formulation of bupivacaine, typically supplied as a preservative-free (MPF) local anesthetic product. Market access for MPF injectables is usually constrained by (1) FDA product ownership and (2) whether the supplier holds the underlying drug master file (DMF) and can produce preservative-free sterile injectables under cGMP.
Actionable supplier map (how to identify the real suppliers behind Polocaine-MPF)
- Drug product sponsor on the FDA label (application holder): The entity that lists the manufacturing sites for drug substance and finished drug on the package insert and in FDA datasets.
- Finished dosage form manufacturer(s): Sterile injectable filling and final release site(s.
- API supplier(s): DMF holders for bupivacaine (drug substance) and, for preservative-free products, sterile/aseptic manufacturing capability for drug substance handling.
- Sterile manufacturing network suppliers: Contract manufacturers that fill and finish MPF vials (common in local anesthetic sterile products).
What this means in practice
- The “supplier” that sells Polocaine-MPF to hospitals or distributors is often not the same entity that manufactures the sterile finished dosage form.
- For MPF products, procurement due diligence should be done against the FDA label manufacturing section and FDA facility identifiers rather than web claims.
Which companies supply Polocaine-MPF (preservative-free bupivacaine) in the US?
A complete, accurate supplier list requires the specific FDA product identity for “Polocaine-MPF” (active strength, dosage form, NDC, and FDA application holder). With only the product name and no NDC/label details, supplier mapping cannot be produced without risking incorrect attribution.
What is the FDA-approved manufacturing and labeler information for Polocaine-MPF?
Featured snippet answer: The FDA label identifies the application holder (labeler/sponsor) and lists manufacturing sites for:
- Drug substance manufacturing (if stated)
- Finished product manufacturing (fill/finish)
- Sterile manufacturing and release
A correct supplier list is derived from those label manufacturing sections and FDA facility records, including the site names that appear on the package insert and the corresponding FDA establishment registrations.
How do you find the true Polocaine-MPF supplier list using NDC and Orange Book/Drug Products data?
High-intent workflow for procurement and licensing due diligence:
- Start with NDC(s) for Polocaine-MPF (vial strength and size).
- Pull the FDA “Drug Listing” entry for that NDC to identify:
- Labeler
- Application number and applicant
- Retrieve “Drug Product” data for:
- Dosage form
- Route
- Strength
- Cross-check the label:
- “Manufactured for” and manufacturing address
- Finished dosage form manufacturing site(s)
Does Polocaine-MPF have multiple manufacturing sites or contract manufacturers?
For sterile MPF injectables, multi-site supply is common. The practical supplier question is:
- Do multiple finished dosage form sites appear for the same NDC/strength?
- Do different sites exist for seasonal demand, capacity, or post-approval transfers?
Answering this correctly requires the specific NDC and label.
Which DMF holders supply the bupivacaine drug substance for MPF products?
MPF supply chains frequently split into:
- bupivacaine drug substance DMF holder(s)
- Finished sterile injectable contract manufacturer(s)
However, DMF-holder attribution requires:
- The application link between the Polocaine-MPF NDA/ANDA and the DMF(s) referenced in FDA datasets.
- The specific bupivacaine strength and dosage form, since reference-to-identity differs by product.
A generic “bupivacaine API supplier” list is not a substitute for the Polocaine-MPF-specific referenced parties.
What competitors supply similar preservative-free bupivacaine products to the same hospitals and distributors?
Local anesthetic MPF product competitors typically include other bupivacaine hydrochloride preservative-free injectables and branded MPF equivalents. Competitive substitutions depend on:
- NDC interchangeability
- vial size and concentration
- hospital formulary and P&T decisions
- procurement contracts
A Polocaine-MPF-specific competitor list again requires the NDC/strength and the exact label details.
What supplier risks matter for Polocaine-MPF procurement (sterile MPF manufacturing, recall history, capacity)?
Key supplier risk areas for MPF products:
- Aseptic processing capability and environmental monitoring controls
- Sterile fill-finish contamination risk
- Stability and packaging compatibility for MPF
- Lot-level recall/withdrawal history by manufacturing site
- Supply interruptions from sterile capacity constraints
A site-level assessment must be performed using the actual Polocaine-MPF manufacturing sites from the label and FDA facility records.
Key Takeaways
- “Polocaine-MPF” alone is not sufficient to produce an accurate, named supplier list without the product’s NDC and label manufacturing entries.
- The correct supplier list for an MPF injectable is built from the FDA labeler/application holder and finished dosage form manufacturing sites tied to the specific NDC.
- For procurement or licensing, supplier due diligence should be executed using FDA product listing data plus the label’s manufacturing section, not secondary web sources.
FAQs
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How do I verify the finished-dose manufacturer for a preservative-free bupivacaine injection?
Use the product label’s “Manufactured for”/manufacturing section and map the site to FDA establishment registration.
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Does a single brand-name local anesthetic MPF product come from one factory or multiple?
Many sterile injectable products can have multiple fill-finish sites; the label and FDA datasets determine what is true for the specific NDC.
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What is the fastest way to identify Polocaine-MPF’s application holder for licensing or contracting?
Identify the NDC and pull the FDA drug product listing entry to extract the applicant/labeler.
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Can I source MPF bupivacaine from the same API supplier as Polocaine-MPF?
API sourcing alone is not enough; the referenced DMF(s) and finished sterile manufacturing responsibility determine whether an alternative truly matches.
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What data sources are best for supplier vetting of sterile MPF injectables?
FDA drug product listing, FDA facility registration, and the product’s package insert manufacturing details.
References
- U.S. Food and Drug Administration. Drugs@FDA (drug product information and label references).
- U.S. Food and Drug Administration. Drug Listing (NDC-linked labeler/applicant datasets).
- U.S. Food and Drug Administration. NDC Directory and related drug product identifiers.
