Suppliers and packagers for LATISSE

LATISSE

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	LATISSE	bimatoprost	SOLUTION/DROPS;TOPICAL	022369	NDA	Allergan, Inc.	0023-3616-05	1 BOTTLE, DROPPER in 1 CARTON (0023-3616-05) / 5 mL in 1 BOTTLE, DROPPER	2009-01-26
Abbvie	LATISSE	bimatoprost	SOLUTION/DROPS;TOPICAL	022369	NDA	Allergan, Inc.	0023-3616-70	1 BOTTLE, DROPPER in 1 CARTON (0023-3616-70) / 3 mL in 1 BOTTLE, DROPPER	2009-01-26
Abbvie	LATISSE	bimatoprost	SOLUTION/DROPS;TOPICAL	022369	NDA	Allergan, Inc.	0023-3616-71	1 BOTTLE, DROPPER in 1 CARTON (0023-3616-71) / 3 mL in 1 BOTTLE, DROPPER	2009-01-26

Suppliers for LATISSE (bimatoprost ophthalmic solution 0.03%): who manufactures, packages, and supplies the active ingredient and finished product

Last updated: May 23, 2026

LATISSE is a branded prostaglandin analog delivered as a 0.03% bimatoprost solution. Supplier mapping depends on the specific stage: active pharmaceutical ingredient (API) bimatoprost, sterile fill-finish and packaging for the finished ophthalmic solution, and secondary-market distributors for wholesales and specialty channels.

Which companies supply LATISSE in the US market?

Answer (US, practical sourcing): Identify the manufacturer and packager listed as the applicant/manufacturer for LATISSE’s NDC on FDA’s Drug Label/Orange Book record, then trace the product’s contract manufacturing and distribution via the same label “Manufactured for/Distributed by” lines and wholesaler catalogs. In practice, LATISSE supply is carried through established ophthalmic drug distribution networks, while the sterile ophthalmic supply chain is dominated by contract sterile fill-finish and packaging sites qualified for ophthalmic products.

What do label “Manufactured for” and “Distributed by” lines show?

For procurement or licensing due diligence, the label typically lists:

• Manufactured for: applicant/marketer and/or manufacturer of record (often the applicant plus a contract manufacturer name and address).
• Distributed by: the marketing entity that controls US distribution.
• Sterility and dosage-form statements: support traceability for sterile manufacturing and packaging.

Who is the marketing authorization holder for LATISSE?

LATISSE is marketed in the US under AbbVie’s trade ecosystem (the current US marketer is the entity shown on the latest FDA label). The manufacturer of record and the contract fill-finish site can change over time.

What suppliers make LATISSE bimatoprost 0.03% ophthalmic solution?

Answer: LATISSE is a sterile ophthalmic solution using bimatoprost as the API. Suppliers break into:

1. API bimatoprost suppliers (chemical synthesis)
2. Sterile solution compounding and fill-finish (aseptic processing, sterile filtration, container-closure system filling)
3. Primary packaging (sterile dropper bottle and solution fill)
4. Secondary packaging and labeling (cartoning, labeling, unit pack configuration)

How to map LATISSE’s API supply chain

Procurement teams typically map bimatoprost API supply via:

• the US DMF holder(s) for bimatoprost used in the finished product, where applicable
• supplier declarations in regulatory submissions
• manufacturing statements on product labels
• vendor qualification records (cGMP audits) for sterile ophthalmic products

How to map LATISSE’s sterile manufacturing and fill-finish suppliers

For LATISSE, sterile fill-finish vendors must provide:

• aseptic processing controls for ophthalmic sterility assurance
• validated sterilization/aseptic filling approach compatible with aqueous ophthalmic solutions
• appropriate container-closure integrity testing for dropper bottles
• label-claim traceability (lot genealogy)

Which companies are listed as manufacturers/packagers for LATISSE on the label?

Answer: The label “Manufactured for”/“Distributed by” section is the controlling field for the finished product supply chain. Supplier names and addresses change with contract manufacturing cycles, so the only defensible approach is to use the latest FDA label for each NDC and compile:

• manufacturer of record
• packaging site(s)
• distribution entity

What to capture in a supplier dossier

Build a dossier per NDC containing:

• NDC label version date
• manufacturer name(s) and address(es) from the label
• packaging labeler entity if listed separately
• strength and dosage form (0.03% ophthalmic solution)
• bottle count per carton (for forecast and logistics)

Are LATISSE suppliers different from the manufacturer of the Latisse active ingredient?

Answer: Yes. For ophthalmic solutions, API and sterile fill-finish are commonly separated by geography, economics, and cGMP specialization. Even when a single vertically integrated supplier exists, the dropper-bottle sterile product manufacturing typically requires dedicated aseptic fill-finish capacity.

Common separation points in ophthalmic product supply

• bimatoprost chemical synthesis (API)
• sterile aqueous formulation and filtration
• dropper bottle filling and container-closure integrity testing
• aseptic warehousing and labeling

How many suppliers can be involved across the LATISSE value chain?

Answer: Typically more than one supplier across the chain:

• 1+ bimatoprost API supplier(s)
• 1–2 sterile fill-finish/packaging sites for finished product
• multiple logistics and wholesale distribution partners

What drives supplier multiplicity

• supply continuity planning (single-site risk mitigation)
• batch-to-batch quality systems and release capacity
• seasonal demand fluctuations in cosmetic-adjacent ophthalmic products

What manufacturing/IP barriers affect switching LATISSE suppliers?

Answer: LATISSE is tied to formulation and regulatory control points, so switching is constrained by:

• sterile manufacturing know-how and validated process parameters
• container-closure system compatibility
• stability and shelf-life package testing
• change control under cGMP and comparability expectations

What to watch in supplier qualification

• aseptic process validation status
• sterility test method and acceptance criteria
• stability program for the specific bottle configuration
• raw material quality agreements (API specs for bimatoprost)
• cross-contamination controls (ophthalmic grade handling)

What generic or biosimilar competition changes LATISSE supplier dynamics?

LATISSE is a small-molecule topical/ophthalmic prostaglandin analog product, not a biologic. The relevant competitive pressure is generic ophthalmic solution products with the same active ingredient and strength.

Practical impact on suppliers: generic demand can shift API pricing and capacity, and it can also influence sterile fill-finish vendor allocation. However, the supply chain for ophthalmic sterile solutions remains cGMP-constrained and qualification-heavy.

Key takeaways

• LATISSE’s sourcing splits into API bimatoprost suppliers and sterile ophthalmic fill-finish/packaging suppliers.
• The only precise way to identify finished-product suppliers is through the latest FDA label for each NDC, using the “Manufactured for” and “Distributed by” sections.
• Switching suppliers in sterile ophthalmic solutions is constrained by aseptic process validation, container-closure compatibility, and stability/release qualification.

FAQs

1) How do I identify the exact manufacturer of LATISSE for a given NDC?
Use the most recent FDA label for the specific NDC and extract the “Manufactured for” and “Distributed by” entries.

2) Who supplies bimatoprost API used in LATISSE?
API suppliers are identified through the bimatoprost regulatory documentation and DMF linkages used by the finished-product manufacturer, plus qualification records from the finished-product label/manufacturer.

3) Are LATISSE’s sterile fill-finish and packaging done by the same company as the API supplier?
Usually not. API supply is often separate from sterile ophthalmic formulation and aseptic fill-finish.

4) What barriers prevent LATISSE from switching to a new contract sterile manufacturer quickly?
Aseptic process validation, container-closure integrity, ophthalmic formulation stability, and lot release comparability under cGMP.

5) Does generic entry for bimatoprost solutions affect LATISSE suppliers?
It can affect API pricing and fill-finish capacity allocation, but supplier switching remains limited by sterile qualification and regulatory control.

References

1. FDA. Orange Book and drug labeling resources for LATISSE (bimatoprost ophthalmic solution 0.03%).
2. FDA. Drug labels for LATISSE via DailyMed/FDA labeling feeds (latest label version for each NDC).