Suppliers and packagers for LASTACAFT

What is “Lastacaft” and who manufactures it?

Lastacaft is the brand name for alcaftadine ophthalmic solution (commonly supplied as 0.25% and 0.06% strengths depending on the market and formulation). The branded product is sold by Allergan/AbbVie in the US and other territories, with manufacturing and supply handled through Allergan’s commercial network (historically including contract manufacturing and affiliate sites).

Regulatory anchor points used to identify suppliers

For branded ophthalmics, the authoritative way to identify manufacturing suppliers is through:

• FDA Orange Book (for listed drug, applicant/holder, and Orange Book “manufacturer” listings)
• FDA labeling (Prescribing Information) (lists manufacturer and distributor details)
• Drug approval package and submission history (links to applicant/holder and manufacturing sites)

Because “suppliers” can mean multiple roles (marketing authorization holder vs. manufacturer vs. distributor vs. API maker), this supply map is limited to what can be directly tied to regulatory submissions for the listed drug.

Who is the marketing authorization holder and applicant/holder?

United States (FDA Orange Book listing)

The Orange Book ties the drug to an applicant/holder and lists manufacturers for the finished dosage form. For Lastacaft, the relevant holder is Allergan (now under AbbVie corporate structure) as the brand’s regulatory owner.

Which finished-dose manufacturers are listed for Lastacaft?

Manufacturing suppliers for Lastacaft are those listed on FDA Orange Book and in the product labeling for each strength/form (for example, 0.06% vs 0.25% solution). The Orange Book typically records:

• Finished dose manufacturers (site-level manufacturer or company listing)
• Application/labeler responsible for the listed drug

Actionable takeaway: supplier selection for Lastacaft as an R&D or partnership target should be built from the Orange Book manufacturer list and labeling manufacturer statements for each specific strength.

API and intermediate supply: who makes alcaftadine active?

Alcaftadine API sourcing is typically split into:

• API manufacturer(s) for the alcaftadine drug substance
• Finished-dose contract manufacturing for the ophthalmic solution

For branded ophthalmics, finished-dose manufacturers are often easier to pin to regulatory label language than API suppliers, unless the approval documents explicitly identify drug substance manufacturers.

What supply roles matter for business decisions?

Procurement and licensing teams generally need four distinct supplier role definitions:

1. Finished-dose manufacturer
   Company/site that produces the final alcaftadine ophthalmic solution.

2. Labeler/holder (regulatory owner)
   The applicant or marketing authorization holder named in Orange Book and labeling.

3. API manufacturer
   Site that produces alcaftadine drug substance.

4. Distributor
   Entity that ships to wholesalers or channels; often aligned with the holder or logistics subcontractor.

Which documents best surface the supplier list?

Use these exact document types:

• FDA Orange Book record for the specific Lastacaft strength (0.25% and 0.06%).
• Prescribing Information (label front/back and “Manufactured for” / “Distributed by” sections).
• FDA review documents if you are tracing drug substance manufacturing.

How should you structure a supplier shortlist for Lastacaft?

A defensible shortlist for contracting, due diligence, or investment diligence should separate finished-dose and API:

Finished-dose shortlist (regulatory listed manufacturers)

• Pull every manufacturer listed for Lastacaft by strength and dosage form from the Orange Book.
• Confirm each by matching the labeling “Manufactured by / for” statements.

API shortlist (drug substance supply)

• Only include API suppliers that appear in FDA submissions or explicit labeling/manufacturing statements.
• Where the record is silent, treat API supplier identification as part of the regulatory dossier review rather than procurement hearsay.

Key Takeaways

• Lastacaft is alcaftadine ophthalmic solution; supplier identification must be anchored to FDA Orange Book manufacturer listings and prescribing information label statements for the specific strength and formulation.
• The marketing authorization holder is Allergan/AbbVie (regulatory owner of the branded product in the US).
• “Suppliers” split into finished-dose manufacturers, API makers, and distributors; business decisions should not blur these roles.
• The most actionable supplier list is the Orange Book manufacturer list plus labeling confirmation per strength.

FAQs

1. Is the supplier list the same for Lastacaft 0.06% and 0.25%?
   Not necessarily. Finished-dose manufacturing can differ by strength, packaging configuration, and revision cycles.

2. Does the Orange Book list the API manufacturer for Lastacaft?
   Often it lists finished-dose manufacturers for the listed drug. API maker identification can require review-level submission content.

3. Who is the labeler for Lastacaft in the US?
   The brand’s regulatory owner is Allergan/AbbVie under the Allergan product portfolio.

4. Where do I verify the actual manufacturing supplier for the finished product?
   In the Prescribing Information labeling, typically in the “Manufactured for” / “Manufactured by” and “Distributed by” sections, and in the Orange Book entry for the listed drug.

5. What is the best way to build a contract-manufacturing shortlist?
   Extract the Orange Book manufacturer sites for Lastacaft and validate against labeling for each strength, then layer in dossier-level review for API sourcing.

References

[1] FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Lastacaft, alcaftadine ophthalmic solution). U.S. Food and Drug Administration.
[2] FDA. Lastacaft (alcaftadine) Prescribing Information (manufacturer/distributor statements). U.S. Food and Drug Administration.