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Suppliers and packagers for generic pharmaceutical drug: TIMOLOL
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TIMOLOL
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 |
| Somerset | TIMOLOL | timolol | SOLUTION/DROPS;OPHTHALMIC | 216654 | ANDA | Somerset Therapeutics, LLC | 70069-696-01 | 1 BOTTLE in 1 CARTON (70069-696-01) / 5 mL in 1 BOTTLE | 2024-10-31 |
| Somerset | TIMOLOL | timolol | SOLUTION/DROPS;OPHTHALMIC | 216654 | ANDA | Somerset Therapeutics, LLC | 70069-697-01 | 1 BOTTLE in 1 CARTON (70069-697-01) / 10 mL in 1 BOTTLE | 2024-10-31 |
| Somerset | TIMOLOL | timolol | SOLUTION/DROPS;OPHTHALMIC | 216654 | ANDA | Somerset Therapeutics, LLC | 70069-698-01 | 1 BOTTLE in 1 CARTON (70069-698-01) / 15 mL in 1 BOTTLE | 2024-10-31 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Timolol
Introduction
Timolol, a non-selective beta-adrenergic antagonist, is widely used in ophthalmology to treat glaucoma and ocular hypertension, and also in systemic therapy for conditions such as hypertension and certain heart-related ailments. As a cornerstone in managing ocular and cardiovascular conditions, the global supply chain of timolol is critical for healthcare providers, pharmaceutical companies, and patients. This article explores the key suppliers of timolol, focusing on their manufacturing capabilities, regulatory compliance, market presence, and strategic significance amid a dynamic pharmaceutical landscape.
Overview of Timolol as a Pharmaceutical Product
Timolol was first approved in the late 1970s and has since become a vital medication, especially ophthalmic formulations like Timolol maleate eye drops. The drug’s chemical stability, bioavailability, and manufacturing complexity influence the choice of suppliers. Suppliers operate across several regions, including Asia, Europe, and North America, leveraging advanced synthesis techniques and strict quality control protocols.
Major Suppliers of Timolol
1. Teva Pharmaceutical Industries Ltd.
Global Market Leader
Teva, headquartered in Israel, stands out as the world’s largest generic drug manufacturer. It supplies a significant proportion of timolol globally, particularly in ophthalmic formulations. Teva’s extensive manufacturing facilities in Israel, Europe, and North America ensure supply stability and adherence to regulatory standards like FDA and EMA compliance.
Manufacturing Capabilities
Teva’s production includes both active pharmaceutical ingredients (API) and finished dosage forms. Their integrated supply chain allows for large-scale production, ensuring availability across diverse markets. Rigorous quality assurance aligns with international GMP standards ([1]).
2. Sandoz (Novartis)
Legacy and Innovation
Sandoz, a Novartis division, is renowned for its flexibly manufactured generics, including timolol. They have a robust API production network primarily based in Europe and India, providing both ophthalmic and systemic formulations.
Regulatory and Quality Assurance
Sandoz maintains high-quality manufacturing processes with compliance to global standards, making them a reliable supplier for emerging markets and developed economies alike ([2]).
3. Sun Pharmaceutical Industries Ltd.
Key Player in the Indian Market
Sun Pharma is among the leading producers of timolol and other beta-blockers in India. The company's API manufacturing capabilities are extensive, serving both domestic and international demands.
Strategic Positioning
Sun Pharma’s cost-effective production and global regulatory approvals allow it to compete effectively in emerging markets, supplementing supply chains for ophthalmic and systemic uses ([3]).
4. Aurobindo Pharma Ltd.
Growing API Supplier
Aurobindo, based in India, is a significant player in APIs, including timolol. Their facilities emphasize quality control, cost efficiency, and compliance with major regulatory agencies such as the US FDA and EMA.
Market Penetration
Aurobindo supplies both API and finished dosage forms, focusing on affordability and high-volume demand, particularly in developing regions ([4]).
5. Pfizer Inc.
Historical Contributions and Strategic Shifts
Although Pfizer’s involvement with timolol has decreased as many intents shifted toward generics, the company historically contributed to the distribution and development of ophthalmic beta-blockers. Existing manufacturing sites and licensing agreements continue to sustain some supply channels.
Manufacturing and Supply Chain Considerations
API Synthesis and Quality Control
Timolol API is synthesized via multiple chemical pathways, involving the reduction of specific intermediates under controlled conditions. Manufacturers must meet stringent specifications for purity, stability, and bioavailability. Variability in manufacturing processes can influence drug efficacy, making supplier qualification critical.
Regulatory Compliance
Suppliers must adhere to Good Manufacturing Practices (GMP) regulated by entities such as the FDA, EMA, and other national agencies. Regulatory audits and batch testing are routine, ensuring consistent quality across lots and regions.
Supply Chain Risks
Global supply chains face disruptions from geopolitical tensions, raw material shortages, and manufacturing setbacks, as seen during the COVID-19 pandemic. Diversification of supply sources mitigates these risks, underscoring the importance of suppliers like Teva, Sandoz, Sun Pharma, and Aurobindo.
Market Trends and Future Directions
Increasing demand for ophthalmic medications and the potential for new indications for beta-blockers continue to influence supplier strategies. Innovation in formulation technology and entry into biosimilar markets may alter the landscape in coming years.
Strategic Implications for Industry Stakeholders
Pharmaceutical companies should prioritize supplier qualification, establish multiple sourcing options, and closely monitor regulatory compliance and quality standards. Building relationships with reliable suppliers ensures uninterrupted availability of timolol, supporting long-term market stability.
Manufacturers should also explore emerging markets where local API production capacities are expanding, reducing dependence on traditional supply chains and potentially lowering costs.
Conclusion
The global supply of timolol is sustained by leading pharmaceutical manufacturers primarily based in Israel, India, and Europe. Teva, Sandoz, Sun Pharma, and Aurobindo dominate the API and finished product markets, with regulatory compliance and manufacturing capacity playing pivotal roles in supply security. Stakeholders must continuously evaluate supplier reliability, monitor geopolitical and regulatory landscapes, and adapt to shifting market demands to maintain consistent timolol availability.
Key Takeaways
- The top timolol suppliers include Teva, Sandoz, Sun Pharma, and Aurobindo, each with robust manufacturing capabilities and global regulatory approvals.
- Ensuring quality and regulatory compliance is crucial, given the clinical importance of timolol and the potential risks associated with substandard products.
- Diversification of supply sources reduces risks associated with manufacturing disruptions and geopolitical issues.
- Increasing demand and evolving formulations necessitate ongoing innovation and strategic sourcing by pharmaceutical stakeholders.
- Market dynamics, including emerging markets and biosimilar innovations, will influence future sourcing strategies for timolol.
FAQs
1. What are the primary regions producing timolol API?
India, Israel, and European countries like Germany and Switzerland are key regions, with manufacturing facilities that meet international GMP standards.
2. How do regulatory standards impact supplier selection for timolol?
Suppliers must demonstrate compliance with FDA, EMA, and other regional agencies' GMP standards, ensuring the API and finished products meet safety, efficacy, and quality benchmarks.
3. Is there a difference between branded and generic timolol suppliers?
Yes. Branded suppliers typically produce proprietary formulations with brand recognition, while generics—supplied by companies like Teva and Sandoz—offer equivalent products at lower costs, often manufactured by multiple suppliers.
4. What are the risks associated with timolol supply chain disruptions?
Risks include raw material shortages, geopolitical tensions, manufacturing failures, and regulatory delays, all potentially impacting drug availability.
5. How might future innovations impact timolol supply?
Advancements in formulation technology, biosimilars, and regional manufacturing efforts may diversify sources, reduce costs, and improve supply resilience.
Sources:
[1] Teva Pharmaceutical Industries Ltd. Annual Report, 2022.
[2] Sandoz (Novartis) Corporate Overview, 2022.
[3] Sun Pharmaceutical Industries Ltd. Annual Report, 2022.
[4] Aurobindo Pharma Ltd. Regulatory Filing Data, 2022.
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