Suppliers and packagers for LOTEMAX SM

LOTEMAX SM

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 Inc	LOTEMAX SM	loteprednol etabonate	GEL;OPHTHALMIC	208219	NDA	Bausch & Lomb Incorporated	24208-507-01	1 BOTTLE in 1 CARTON (24208-507-01) / .5 g in 1 BOTTLE	2019-02-25
Bausch And Lomb Inc	LOTEMAX SM	loteprednol etabonate	GEL;OPHTHALMIC	208219	NDA	Bausch & Lomb Incorporated	24208-507-07	1 BOTTLE in 1 CARTON (24208-507-07) / 5 g in 1 BOTTLE	2019-02-25

Suppliers and packagers for LOTEMAX SM

Last updated: May 28, 2026

LOTEMAX SM (loteprednol etabonate ophthalmic) suppliers: who makes it, ships it, and supplies inputs for generic and reformulation risk

LOTEMAX SM is an ophthalmic suspension product. Supply chain mapping depends on the specific market’s labeled product, strength, dosage form, and manufacturer-of-record listed on the FDA label. With only the product name provided and without the corresponding FDA label/manufacturer-of-record, a complete and accurate supplier identification for LOTEMAX SM cannot be produced.

Who supplies LOTEMAX SM to pharmacies and wholesalers?

A definitive answer requires the labeled manufacturer (drug product manufacturer) and the FDA-registered site(s) for the marketed NDA product. Those data are typically captured in:

• The FDA label “Manufactured for/Manufactured by” block
• FDA’s facility registration listings tied to the approved NDA product and dosage form

With the product name alone, supplier-of-record and site-level suppliers cannot be confirmed.

Which companies are the drug product manufacturer for LOTEMAX SM?

Supplier identification is not possible from the product name alone because multiple loteprednol etabonate ophthalmic presentations exist and can have different NDA owners, contract manufacturers, and labeling variations by country and package.

Which contract manufacturers produce LOTEMAX SM ophthalmic suspension?

Contract manufacturing site assignment is label- and market-specific. Site-level mapping cannot be completed without the exact FDA label for LOTEMAX SM.

What raw-material suppliers provide loteprednol etabonate for LOTEMAX SM?

Raw material supply chains require:

• The active pharmaceutical ingredient (API) manufacturer or API supplier listed via FDA inspection databases, DMF-linked suppliers, or internal procurement mappings tied to the approved NDA/ANDA
• API intermediate sources for loteprednol etabonate synthesis

A correct list cannot be generated without the NDA number, DMF linkage, or manufacturer disclosure for the approved product.

Who manufactures loteprednol etabonate API used in LOTEMAX SM?

API suppliers are not discoverable at the product-name level because:

• Multiple DMFs can exist for the same API
• Different NDA products can reference different DMFs or different manufacturing processes

How do you identify LOTEMAX SM suppliers from the FDA label and Orange Book?

The supplier set for a branded ophthalmic product is built from two anchors:

1. Orange Book: identifies the application (NDA/505(b)(2)) and lists listed patents, but not always a full supplier roster.
2. FDA Label: provides the manufacturer-of-record that distributors and pharmacies rely on.

A supplier list requires the specific NDA label text for LOTEMAX SM.

What does “Manufactured for” versus “Manufactured by” mean for LOTEMAX SM suppliers?

• “Manufactured by” points to the drug product site responsible for manufacturing the finished ophthalmic suspension.
• “Manufactured for” can indicate brand ownership with a separate contract manufacturer behind the scenes. Without the label block, the supplier-of-record cannot be resolved.

Which facilities supply manufacturing for LOTEMAX SM (NDC-specific)?

Facility supply mapping is NDC-specific for ophthalmic products because:

• Different strengths (e.g., suspension concentration) can be tied to different manufacturing runs
• Packaging configurations can shift between sites

No NDC, label, or NDA-specific facility detail is available from the product name alone, so the supplier roster cannot be completed.

Are there generic LOTEMAX SM suppliers at risk of entry, and who are they?

A generic “LOTEMAX SM” entry depends on:

• Whether there is a corresponding ANDA or 505(b)(2) referencing the branded product
• Whether Paragraph IV challenges exist
• Whether there are settlement agreements affecting launch timing

No Orange Book / ANDA facts are provided, so supplier candidates for generics cannot be identified.

What formulations and manufacturing/IP barriers change the supplier list for LOTEMAX SM?

Supplier eligibility for ophthalmic suspensions depends on:

• Sterile fill-and-finish and aseptic capability for ophthalmic dosage forms
• Particle-size control, suspension stability, container closure system compatibility
• Patents covering formulation, particle properties, preservatives, and dosing regimens

Without the NDA formulation details and manufacturing process description, supplier barrier mapping cannot be completed.

Key Takeaways

• A complete, accurate supplier list for LOTEMAX SM cannot be produced from the product name alone.
• Supplier-of-record for drug product manufacturing and site-level manufacturing requires the FDA label and NDA/NDC-specific documentation.

FAQs

1) How do I find the drug product manufacturer for LOTEMAX SM from FDA records?
By using the FDA label “Manufactured by/Manufactured for” block tied to the exact NDC.

2) Who supplies loteprednol etabonate API used in LOTEMAX SM?
API suppliers are linked through DMF references to the approved NDA for the specific product presentation and NDC.

3) Which sites make LOTEMAX SM ophthalmic suspension?
Drug product manufacturing sites are determined by label “manufactured by” and FDA facility registration tied to that NDC.

4) Do generic versions of LOTEMAX SM have different suppliers?
Yes, generics can switch to different contract manufacturers and packaging sites, but identifying them requires Orange Book and ANDA-specific records.

5) Does supplier mapping differ by country or package size?
Yes, manufacturer-of-record and packaging sites can differ by market and NDC; mapping requires the specific local label and NDC.

References

No sources were cited because no NDA/NDC/FDA label or Orange Book records were provided in the prompt.