Suppliers and packagers for betimol

betimol

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Thea Pharma	BETIMOL	timolol	SOLUTION/DROPS;OPHTHALMIC	020439	NDA	Thea Pharma Inc.	82584-002-05	1 BOTTLE, DROPPER in 1 CARTON (82584-002-05) / 5 mL in 1 BOTTLE, DROPPER	2022-11-15

Suppliers for the Pharmaceutical Drug: Betimol

Last updated: July 29, 2025

Introduction

Betimol, known by its generic name timolol maleate, is a beta-blocker primarily prescribed for managing ocular conditions such as glaucoma and ocular hypertension. Its efficacy in reducing intraocular pressure has cemented its role in ophthalmological therapy. As a critical medication, understanding the supply landscape for Betimol is essential for stakeholders ranging from healthcare providers to pharmaceutical distributors. This article provides a comprehensive overview of the key suppliers involved in the production and distribution of Betimol, elucidating the competitive dynamics, manufacturing sources, and supply chain considerations pertinent to this medication.

Overview of Betimol (Timolol Maleate)

Betimol, a topical ophthalmic solution, contains timolol maleate as its active ingredient. The compound is a non-selective beta-adrenergic antagonist that decreases intraocular pressure by reducing aqueous humor production. First introduced in the late 20th century, Betimol remains a standard treatment in ophthalmology. Its widespread use has driven a global market with multiple manufacturers and distributors.

Manufacturers of Timolol Maleate

The core supply chain for Betimol begins with active pharmaceutical ingredient (API) manufacturing. Several pharmaceutical companies globally produce timolol maleate, either locally or through API outsourcing agreements. The main players include:

1. Novartis AG — A prominent contributor to ophthalmic medications, Novartis manufactures both branded and generic timolol products. Although Betimol itself may not be marketed directly by Novartis, the company's API manufacturing capabilities influence the supply chain.

2. Synthesis Laboratories — Several generic drug manufacturers, particularly in India and China, produce timolol maleate APIs. Companies such as Aurobindo Pharma, Sun Pharmaceutical Industries, and Lupin Limited are notable API producers supplying to various formulation manufacturers.

3. Mitsubishi Tanabe Pharma Corporation — Manufacturing and marketing ophthalmic solutions containing timolol, contributing to both branded and generic markets.

4. Alcon (a Novartis division) — Produces ophthalmic solutions, including formulations containing timolol. Their production facilities contribute indirectly to the supply of Betimol, especially in regions where they distribute their branded products.

5. Other Regional Manufacturers — Companies in South Korea, Turkey, and European countries manufacture timolol as part of their ophthalmic portfolio, often supplying local markets or exporting to global distributors.

Distribution and Supply Chain Dynamics

The supply chain for Betimol involves multiple layers: from API production, formulation, packaging, to distribution. Key aspects include:

• API Suppliers: Generic and branded formulations often source API from multiple manufacturers, allowing for flexible supply channels. Quality standards, such as adherence to Good Manufacturing Practices (GMP), are critical.
• Formulation Manufacturers: Contract manufacturing organizations (CMOs) or pharmaceutical companies produce the ophthalmic solution, incorporating timolol maleate into sterile formulations complying with regulatory standards.
• Regulatory Approvals: Different regulatory agencies (FDA, EMA, WHO) influence manufacturing and distribution. Approved suppliers must meet stringent standards, which can impact supply stability.
• Geographical Distribution: Suppliers often customize based on regional demand. For example, Indian and Chinese suppliers dominate the API market due to cost advantages, while European and U.S. companies focus on formulation and marketing.

Key Suppliers and Their Market Positions

Supplier	Role	Market Focus	Notable Attributes
Aurobindo Pharma	API manufacturer	Global, with focus on India, Europe, USA	Extensive API portfolio, low-cost manufacturing
Sun Pharmaceutical Industries	API and formulation	India, North America, Europe	Diversified product range, strong research
Lupin Limited	API and formulations	India, emerging markets	Cost-effective API production
Novartis AG	Branded formulations (Controlling Betimol distribution in some markets)	Global	Innovative ophthalmic solutions
Santen Pharmaceutical	Ophthalmic formulations	Japan, Asia, Europe	Focused ophthalmology portfolio

Supply Risks and Challenges

Supply stability for Betimol hinges on several factors:

• API Supply Disruptions: Political, regulatory, or manufacturing issues at API plants can cause shortages. Decentralized API manufacturing mitigates this risk, but dependency on specific suppliers can create vulnerabilities.
• Regulatory Barriers: Stringent approvals may delay the entry of new suppliers or formulations, impacting market supply.
• Pricing Dynamics: Competitive pressures, especially from generics, influence supplier margins, which can impact production incentives.
• Quality Compliance: Ensuring consistent GMP standards across multiple suppliers is essential to prevent recalls or regulatory actions.

Market Trends and Future Outlook

• Growing Demand: The prevalence of glaucoma globally, particularly in aging populations, sustains demand for timolol-based therapies. This drives the need for reliable suppliers.
• Generic Market Expansion: The dominance of generic formulations, produced by Indian and Chinese manufacturers, suggests an increasing supply network and potential price reductions.
• Supply Chain Resilience: Companies are diversifying their supplier base and investing in quality assurance to mitigate risks.
• Regulatory Developments: Enhanced global regulatory standards may influence supplier operations and market access.

Key Takeaways

• The primary sources of Betimol supply are generic API producers in India, China, and other emerging markets, complemented by formulation manufacturers worldwide.
• Leading API suppliers include Aurobindo Pharma, Sun Pharma, and Lupin, with well-established quality and regulatory compliance frameworks.
• Disruptions at API manufacturing sites pose risks, underscoring the importance of diversified supply chains.
• Branded formulations, such as those by Novartis and Santen, often serve regional markets, with some manufacturing outsourced to contract manufacturers.
• Continued growth in ophthalmological healthcare demand and evolving regulatory landscapes shape the supply ecosystem for Betimol.

FAQs

1. Who are the major API suppliers for timolol maleate?
Major API suppliers include Aurobindo Pharma, Sun Pharmaceutical Industries, Lupin Limited, and Mitsubishi Tanabe Pharma, primarily based in India and China.

2. Can Betimol be sourced directly from API manufacturers?
Typically, Betimol is sourced via formulation companies that purchase API and produce the ophthalmic solution, but APIs are available for licensed pharmaceutical companies and contract manufacturers.

3. How do regional regulations impact Betimol supply?
Regulatory standards influence manufacturing practices, quality control, and approval processes. Strict regulations may delay new supplier onboarding but ensure product safety and efficacy.

4. Is Betimol production shifting towards generics?
Yes. The global ophthalmic beta-blocker market is increasingly dominated by generics, primarily produced in India and China, leading to broader supply options and competitive pricing.

5. What supply risks should stakeholders monitor?
Stakeholders should monitor API production vulnerabilities, regulatory changes, geopolitical disruptions, and quality compliance issues, all of which can affect Betimol availability.

References

[1] MarketsandMarkets. (2022). Ophthalmic Drugs Market: Global Forecast, Growth & Trends.
[2] GlobalData. (2022). Ophthalmic Drugs – Market Analysis & Competitive Landscape.
[3] U.S. Food and Drug Administration. (2021). Guidance for Industry: Good Manufacturing Practices.
[4] Indian Pharmaceutical Market. (2022). Top API Manufacturers Overview.
[5] National Pharmaceutical Regulatory Agency (NPRA), Malaysia. (2022). API Manufacturing Standards.