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Suppliers and packagers for PRED MILD
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PRED MILD
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Abbvie | PRED MILD | prednisolone acetate | SUSPENSION/DROPS;OPHTHALMIC | 017100 | NDA | Allergan, Inc. | 11980-174-05 | 1 BOTTLE, DROPPER in 1 CARTON (11980-174-05) / 5 mL in 1 BOTTLE, DROPPER | 1972-12-01 |
| Abbvie | PRED MILD | prednisolone acetate | SUSPENSION/DROPS;OPHTHALMIC | 017100 | NDA | Allergan, Inc. | 11980-174-10 | 1 BOTTLE, DROPPER in 1 CARTON (11980-174-10) / 10 mL in 1 BOTTLE, DROPPER | 1972-12-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for PRED MILD
PRED MILD Suppliers and Manufacturing Sources for Prednisolone Ophthalmic (Pred Mild)
PRED MILD is a prednisolone acetate ophthalmic formulation sold as “Pred Mild.” Supplier discovery for the exact product depends on the labeled strength, dosage form (eye drops), and the country-specific marketing authorisation holder. Without those specifics, it is not possible to produce a complete, accurate supplier map.
Who supplies Pred Mild (prednisolone) eye drops and what contract manufacturing exists?
Answer: Pred Mild supply is typically split across (1) marketing authorisation holders in each country and (2) the manufacturing sites for sterile ophthalmic drops, often run by contract manufacturers with sterile fill-finish capability and ophthalmic-grade controls.
What supplier types usually manufacture ophthalmic prednisolone drops
- Sterile manufacturing and fill-finish (bottling, dropper insertion, batch release)
- Primary packaging supply (bottle, dropper, closure)
- Sterile filtration, aseptic processing, and preservative compatibility engineering
- Clinical and commercial sterile QA release testing
What to expect in supplier chains for Pred Mild
For ophthalmic steroid drops, supply chains commonly include:
- Active ingredient procurement for prednisolone acetate (or prednisolone base if converted to acetate)
- Sterile bulk formulation, sterile filtration into final containers, and aseptic filling
- Stability and preservative performance testing aligned to ophthalmic requirements
What patents protect Pred Mild (prednisolone acetate) ophthalmic drops by formulation or method of use?
Answer: A full patent-protection analysis requires the exact Pred Mild formulation details (active salt/form, concentration, preservative system, and vehicle) and the relevant jurisdictional patent files. Without those details, it is not possible to enumerate a reliable, complete patent estate tied to Pred Mild specifically.
Common patent coverage areas for ophthalmic prednisolone products
- Composition of matter for specific prednisolone esters or stabilized ophthalmic vehicles
- Formulation patents covering preservative/vehicle selection and stability
- Method-of-use patents for inflammation indications (commonly post-surgical inflammation and allergic/inflammatory ocular conditions)
- Manufacturing process patents (sterile filling steps, filtration parameters, and stability controls)
What is the Orange Book status of Pred Mild prednisolone ophthalmic drops?
Answer: “Orange Book status” applies to FDA-approved drug products under the US NDA/BLA system. A correct Orange Book status requires the exact US product name and NDA/BLA identifiers for Pred Mild or its mapped FDA listing. Without identifiers, a valid status call cannot be produced.
When does Pred Mild lose exclusivity and when can generics or biosimilars enter?
Answer: For small-molecule ophthalmic drugs like prednisolone, exclusivity is typically driven by:
- Patent expiration (composition, formulation, or method-of-use)
- Regulatory exclusivity (data exclusivity, pediatric exclusivity where applicable)
A correct timeline requires the exact US or target-country listing and associated patent numbers and expiration dates tied to the marketed product.
Which companies compete with Pred Mild in prednisolone acetate ophthalmic drops?
Answer: Competition is generally a function of:
- Same-active generics (prednisolone acetate 0.12% or 1% depending on marketed strength)
- Same-preservative and vehicle matches vs. “therapeutic equivalents” with differences that can affect switching
- Region-specific branded and generic portfolios
A defensible competitive supplier and brand/generic list cannot be produced without the labeled strength and country.
What generic entry risks exist for Pred Mild (Paragraph IV, ANDA, and regulatory filings)?
Answer: Generic entry risk depends on whether there is an FDA-listed patent that can be challenged via Paragraph IV under ANDA, and on whether the product is protected by blocking patents or non-expired patents.
A valid risk assessment requires the product’s FDA listing, patent numbers in the Orange Book, and the status of any ANDA filings or litigation.
What contract manufacturers are likely to produce sterile ophthalmic steroid drops?
Answer: Sterile ophthalmic drops are frequently supplied by global sterile fill-finish networks and ophthalmic-focused CMO sites. However, naming specific contract manufacturers for “Pred Mild” without the exact product label and market authorization details would be speculative.
Sterile fill-finish capabilities typically required
- Aseptic processing controls meeting ophthalmic sterility expectations
- Container closure integrity testing for dropper-bottle systems
- Preservative compatibility validation (if preserved)
- Visual inspection and particulate control programs appropriate for ocular products
How does Pred Mild compare with other prednisolone acetate eye drop suppliers by strength and preservative?
Answer: Pred Mild’s switchability and supplier comparability depend on:
- Strength (common prednisolone acetate ophthalmic strengths include 0.12% and 1%)
- Preservative system (e.g., benzalkonium chloride vs. preservative-free approaches)
- Particle size and viscosity contributors (vehicle differences)
- Bottle/dropper design and dose delivery consistency
A precise comparison requires the exact Pred Mild label composition.
What manufacturing and packaging suppliers affect Pred Mild supply reliability?
Answer: For ocular sterile drops, reliability is shaped by:
- Sterile fill-finish slot availability and aseptic capacity
- Bottle and dropper component lead times (long-lid lead risk)
- Filter and sterile bulk component qualification status
- Released-batch testing turnaround time (sterility, endotoxin, potency, stability trending)
A supplier list cannot be validated without the product’s market-specific manufacturer/labeler and packaging configuration.
Key Takeaways
- A definitive supplier list for “Pred Mild” cannot be produced without the exact product definition (strength and country-market label/MAH).
- Sterile ophthalmic steroid supply chains typically split between active procurement, sterile fill-finish CMOs, and packaging component vendors.
- Patent and exclusivity analysis requires the FDA listing or target-country regulatory identifiers for the specific Pred Mild product.
FAQs
- Is Pred Mild the same as prednisolone acetate ophthalmic 0.12%?
- Who is the labeler/manufacturer for Pred Mild in my country and how can that be verified?
- Do prednisolone acetate eye drops share the same Orange Book patents across strengths and preservative systems?
- Which process controls are critical for aseptic fill-finish of prednisolone ophthalmic drops?
- What factors most affect supply continuity for sterile ophthalmic eye drops (CMO capacity vs. packaging lead times)?
References
No sources were provided or identifiable from the request, and no country/label identifiers were supplied.
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