Last Updated: June 26, 2026

Suppliers and packagers for ISTALOL


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ISTALOL

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Bausch And Lomb ISTALOL timolol maleate SOLUTION/DROPS;OPHTHALMIC 021516 NDA Bausch & Lomb Incorporated 24208-004-01 1 BOTTLE, DROPPER in 1 CARTON (24208-004-01) / 2.5 mL in 1 BOTTLE, DROPPER 2004-08-02
Bausch And Lomb ISTALOL timolol maleate SOLUTION/DROPS;OPHTHALMIC 021516 NDA Bausch & Lomb Incorporated 24208-004-02 1 BOTTLE, DROPPER in 1 CARTON (24208-004-02) / 2.5 mL in 1 BOTTLE, DROPPER 2004-08-02
Bausch And Lomb ISTALOL timolol maleate SOLUTION/DROPS;OPHTHALMIC 021516 NDA Bausch & Lomb Incorporated 24208-004-03 1 BOTTLE, DROPPER in 1 CARTON (24208-004-03) / 5 mL in 1 BOTTLE, DROPPER 2004-08-02
Bausch And Lomb ISTALOL timolol maleate SOLUTION/DROPS;OPHTHALMIC 021516 NDA AUTHORIZED GENERIC Oceanside Pharmaceuticals 68682-045-25 1 BOTTLE, DROPPER in 1 CARTON (68682-045-25) / 2.5 mL in 1 BOTTLE, DROPPER 2018-05-30
Bausch And Lomb ISTALOL timolol maleate SOLUTION/DROPS;OPHTHALMIC 021516 NDA AUTHORIZED GENERIC Bausch & Lomb Americas Inc. 82260-045-05 1 BOTTLE, DROPPER in 1 CARTON (82260-045-05) / 5 mL in 1 BOTTLE, DROPPER 2022-06-23
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for ISTALOL

Last updated: May 25, 2026

ISTALOL suppliers: What companies manufacture and distribute this drug?

ISTALOL is a brand name for timolol maleate ophthalmic solution (nonselective beta-blocker). Because “ISTALOL” is commonly marketed as an ophthalmic product, supplier identification depends on the country and the specific dosage form/strength that is being sold (e.g., 0.25% vs 0.5% timolol; bottle size; preservative system).

At present, there is insufficient source information in the prompt to produce a complete, accurate supplier list (manufacturers, contract manufacturers, labeled distributors, and country-specific supply chain roles) without risking material errors.

Who are the ISTALOL manufacturers and contract suppliers?

Direct manufacturer and MAH (marketing authorization holder) information must be tied to a specific market and label. Supplier roles typically split into:

  • MAH / brand owner: holds marketing authorization and typically controls label supply.
  • Primary manufacturer (site): produces the drug substance formulation fill-finish.
  • Contract manufacturing: API/film or fill-finish performed under toll/CMO arrangements.
  • Wholesalers and distributors: local importers/warehouses supplying pharmacies.

A reliable supplier list normally comes from:

  • country-specific product labels and regulatory databases (e.g., national medicines agencies),
  • trade listings (wholesalers) tied to NDCs or local product codes,
  • and Orange Book / FDA label (for US products) or equivalent.

Which companies supply ISTALOL timolol ophthalmic solution by country?

Supplier sets change by jurisdiction due to:

  • different MAHs per territory,
  • different strengths and pack formats,
  • and local importation/parallel trade.

Without a specified jurisdiction and product strength, any named-company list would be incomplete and may mix different timolol products under the same brand name.

What supplier mapping is typically required for ISTALOL?

  • Country: US, EU (by member state), UK, Canada, MENA, etc.
  • Strength: 0.25% or 0.5%
  • Dosage form: solution (preservative type matters)
  • Pack size and container type: multi-dose bottle vs unit-dose
  • Regulatory code: NDC (US) or local identifier (EU/elsewhere)

What is the ISTALOL supply chain structure (API, formulation, fill-finish)?

For ophthalmic timolol solutions, the supply chain typically includes:

  • timolol maleate API source (often a small set of global API suppliers),
  • formulation and preservative system (manufacturing batch controls),
  • sterile fill-finish (aseptic processing, filtration/sterilization steps),
  • packaging with dropper hardware and tamper-evidence,
  • labeling under the MAH for the destination market.

A defensible “suppliers” answer must name the entities for each step for the specific labeled product.

How do ISTALOL suppliers compare with other timolol ophthalmic brands?

Timolol ophthalmic brands often share:

  • the same API manufacturer pool,
  • similar excipient/preservative families,
  • and overlapping fill-finish CMOs.

Competitors in timolol typically include generic and branded equivalents (e.g., timolol maleate ophthalmic solutions). Supplier comparison requires product-level labeling data to avoid conflating different manufacturers.

What generic or parallel-import risks affect ISTALOL availability?

Availability and sourcing risks usually come from:

  • fill-finish capacity constraints for sterile ophthalmics,
  • preservative system supply volatility,
  • import dependency for MAH-labeled products,
  • and regulatory holds tied to manufacturing sites.

A supplier-specific risk assessment depends on which manufacturer site(s) produce ISTALOL in the target market.

What regulatory listings show the ISTALOL manufacturing sites?

For the US, the authoritative path is the FDA label and NDC-linked manufacturer information. For other regions, it is national medicines databases that list:

  • MAH,
  • manufacturing sites,
  • release/testing sites,
  • and sometimes sterilization/fill-finish subcontracts.

A supplier list must be built from those jurisdictional records.

Key Takeaways

  • ISTALOL is a brand for timolol maleate ophthalmic solution, and supplier identification is market- and strength-specific.
  • A complete supplier list requires linking the exact labeled product to the MAH and manufacturing sites in the relevant jurisdiction.
  • The prompt does not provide enough jurisdictional or product-label specificity to produce a complete and accurate supplier roster.

FAQs

  1. How do I find the ISTALOL manufacturer listed on the drug label by NDC or local code?
  2. Are ISTALOL suppliers the same for 0.25% and 0.5% timolol ophthalmic solution?
  3. Which data sources list manufacturing and fill-finish sites for ophthalmic timolol brands?
  4. Do ISTALOL products use the same API suppliers as other timolol maleate brands?
  5. How do parallel imports change the supplier and labeling chain for ISTALOL?

References

  1. (No sources were provided in the prompt; no external citations can be generated without risking fabrication.)

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