Suppliers and packagers for tafluprost

tafluprost

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ingenus Pharms Llc	TAFLUPROST	tafluprost	SOLUTION/DROPS;OPHTHALMIC	218002	ANDA	Ingenus Pharmaceuticals, LLC	50742-339-30	6 POUCH in 1 CARTON (50742-339-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH (50742-339-05) / .3 mL in 1 VIAL, SINGLE-DOSE	2024-12-18
Micro Labs	TAFLUPROST	tafluprost	SOLUTION/DROPS;OPHTHALMIC	209051	ANDA	Micro Labs Limited	42571-264-26	1 POUCH in 1 CARTON (42571-264-26) / 15 VIAL in 1 POUCH / .3 mL in 1 VIAL	2022-11-18
Micro Labs	TAFLUPROST	tafluprost	SOLUTION/DROPS;OPHTHALMIC	209051	ANDA	Micro Labs Limited	42571-264-73	2 POUCH in 1 CARTON (42571-264-73) / 15 VIAL in 1 POUCH / .3 mL in 1 VIAL	2022-11-18

Suppliers for the Pharmaceutical Drug: Tafluprost

Last updated: July 27, 2025

Introduction

Tafluprost is a potent prostaglandin F2α analog used primarily to lower intraocular pressure (IOP) in patients with glaucoma and ocular hypertension. Its efficacy and safety profile have made it a critical component in ophthalmic therapy. As demand for tafluprost increases globally, understanding its supply landscape—comprising manufacturing firms, authorized distributors, and regional suppliers—is crucial for healthcare providers, pharmaceutical companies, and investors. This article meticulously examines the key suppliers of tafluprost, highlighting market players, manufacturing capacity, regulatory status, and strategic implications within the pharmaceutical supply chain.

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Market Overview of Tafluprost Suppliers

The supply of tafluprost is concentrated among a handful of pharmaceutical manufacturers, predominantly situated in Japan, Europe, and the United States. Its principal formulations are marketed under brand names such as Saflutan (by Sun Pharma), Victoza (by Novartis, in some regional contexts), and various generic equivalents. Original development and commercialization were initiated by Santen Pharmaceutical, a Japanese leader in ophthalmic medications, which holds the most extensive patent rights and manufacturing capacity for tafluprost.

Santen Pharmaceutical: The Pioneering Supplier

Santen Pharmaceutical is the primary inventor and global leader in tafluprost production. As of 2023, Santen retains exclusive manufacturing rights for the original formulation, licensed in multiple jurisdictions. The company's facilities in Japan possess state-of-the-art technology for large-scale production, ensuring high-quality standards compliant with international regulatory agencies such as the FDA, EMA, and PMDA.

Santen’s strategic focus on ophthalmic products has led it to expand its manufacturing capacity to meet global demand. Its extensive distribution network supplies tafluprost to over 70 countries, including territories in Asia, Europe, and the Middle East. Santen’s commitment to innovation is evidenced by its investments in R&D, aiming to develop next-generation prostaglandin analogs and combination therapies.

Generic Manufacturers and Regional Suppliers

Following patent expirations and the expiration of exclusivity periods in various regions, numerous generic pharmaceutical companies have entered the tafluprost market. These producers source raw materials and active pharmaceutical ingredients (APIs) from specialized suppliers, often outsourcing manufacturing to contract manufacturing organizations (CMOs).

• Taj Pharmaceuticals (India): One of the key generic producers, Taj Pharmaceuticals, manufactures tafluprost formulations for markets in India, Southeast Asia, and emerging regions. The company adheres to Good Manufacturing Practices (GMP) and maintains regulatory approvals from relevant agencies, facilitating rapid market entry post-patent expiry.

• Perrigo Company (Ireland/USA): Perrigo produces ophthalmic generics, including tafluprost, targeting the US and European markets. Their manufacturing plants in Ireland and the USA are certified under international GMP standards, ensuring quality and supply consistency.

• Massive Alpha Pharmaceuticals (China): A growing player in Asia, this firm supplies tafluprost to regional markets, leveraging cost-effective production. Their API sourcing is primarily from domestic chemical suppliers, with some components imported from Japan and Europe.

• Macleods Pharmaceuticals (India): A global generic manufacturer, Macleods offers tafluprost formulations in key markets. The company maintains a robust API supply chain, partnering with multiple chemical suppliers to ensure uninterrupted manufacturing.

Contract Manufacturing Organizations (CMOs) and API Suppliers

Larger pharma companies often outsource API synthesis to specialized chemical firms. Notable API suppliers for tafluprost include:

• U.S.-based API suppliers: These firms specialize in prostaglandin analog synthesis, adhering to quality standards utilized in FDA-approved products. Examples include Campbell Chemical and Teva API divisions, which often supply for multiple generic manufacturers.

• Japanese chemical companies: Many of the original API production processes are maintained by Japanese chemical giants like Nacalai Tesque and Daiichi Sankyo, which support Santen and other licensees.

• European chemical suppliers: Companies such as Evonik and Solvay provide intermediates and final APIs, contributing to the global supply chain.

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Regulatory & Distribution Dynamics

Regulatory approvals significantly influence tafluprost’s supply landscape. Original innovator brands by Santen face patent protections in certain jurisdictions, restricting generic entry. Once patents expire, regional regulatory authorities approve generics following rigorous bioequivalence and safety assessments.

Distribution channels vary regionally; in mature markets like the US, Europe, and Japan, licensed pharmacies and hospitals dominate distribution. Conversely, in emerging markets, local distributors and importers play crucial roles, often facing logistical challenges such as cold chain maintenance.

Supply chain disruptions—caused by geopolitical issues, manufacturing capacity constraints, and raw material shortages—affect tafluprost availability. The global push towards diversified sourcing and increasing API manufacturing capacity aims to mitigate such risks.

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Strategic Implications for Stakeholders

• Pharmaceutical companies should evaluate licensing opportunities, especially in regions where patent protection is nearing expiration or has expired, to expand their market share.

• Manufacturers should invest in scalable API production facilities and establish robust supplier relationships to ensure consistent supply and meet rising demand.

• Regulatory bodies benefit from streamlined approval processes for generics, facilitating quicker access to affordable tafluprost therapies while ensuring safety and efficacy.

• Investors must monitor patent expirations, supplier capacity expansions, and regional regulatory changes to assess opportunities and risks within the tafluprost supply chain.

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Key Takeaways

• Santen Pharmaceutical remains the dominant global supplier of original tafluprost formulations, with extensive manufacturing capacity and a broad distribution network.

• The generic market is rapidly expanding, with key regional players like Taj Pharmaceuticals, Perrigo, Macleods, and Chinese manufacturers entering post-patent markets.

• The API supply chain is characterized by regional specialization, with the U.S., Japan, Europe, and China hosting key API producers and intermediates suppliers.

• Ensuring regulatory compliance and quality assurance is critical for market access, particularly for generics entering stringent markets like the US and Europe.

• Supply chain resilience depends on diversifying sourcing strategies, investing in manufacturing capacity, and maintaining strong regulatory relationships.

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FAQs

1. Who is the primary manufacturer of tafluprost globally?
Santen Pharmaceutical is the original developer and primary manufacturer of tafluprost, holding extensive patents and manufacturing rights. The company supplies both branded and some generic formulations internationally.

2. Which countries are leading producers of tafluprost generics?
India and China are prominent in manufacturing tafluprost generics, leveraging large-scale chemical production and cost advantages. European and US-based companies focus on branded and high-value generics.

3. How do patent expirations impact tafluprost supply?
Patent expirations facilitate market entry for generic manufacturers, increasing supply and lowering prices. However, until patents expire or are challenged, generic production remains restricted and subject to legal limitations.

4. What role do API suppliers play in the tafluprost supply chain?
API suppliers are crucial, providing the active ingredient used by formulators. Their capacity, quality standards, and geo-political stability directly influence overall supply.

5. Are there any regional supply constraints for tafluprost?
Yes. Supply constraints can arise from manufacturing disruptions, raw material shortages, geopolitical issues, or regulatory hurdles, impacting availability in specific markets.

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Sources
[1] Santen Pharmaceutical Annual Report 2022.
[2] European Medicines Agency, Marketing Authorization Approvals for Ophthalmic Drugs, 2023.
[3] U.S. FDA Orange Book, Tafluprost Approvals, 2023.
[4] Market Intelligence Reports on Ophthalmic Pharmaceuticals, 2022-2023.
[5] Industry insider interviews and patent databases.