Suppliers and packagers for generic pharmaceutical drug: BRIMONIDINE TARTRATE

BRIMONIDINE TARTRATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Galderma Labs Lp	MIRVASO	brimonidine tartrate	GEL;TOPICAL	204708	NDA	Galderma Laboratories, L.P.	0299-5980-00	1 TUBE in 1 BLISTER PACK (0299-5980-00) / 2 g in 1 TUBE	2013-08-23
Galderma Labs Lp	MIRVASO	brimonidine tartrate	GEL;TOPICAL	204708	NDA	Galderma Laboratories, L.P.	0299-5980-02	2 g in 1 TUBE (0299-5980-02)	2013-08-23
Galderma Labs Lp	MIRVASO	brimonidine tartrate	GEL;TOPICAL	204708	NDA	Galderma Laboratories, L.P.	0299-5980-30	30 g in 1 TUBE (0299-5980-30)	2013-08-23
Padagis Israel	BRIMONIDINE TARTRATE	brimonidine tartrate	GEL;TOPICAL	209158	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-078-30	1 BOTTLE, PUMP in 1 CARTON (45802-078-30) / 30 g in 1 BOTTLE, PUMP	2023-01-01
Padagis Israel	BRIMONIDINE TARTRATE	brimonidine tartrate	GEL;TOPICAL	209158	ANDA	Bryant Ranch Prepack	63629-9616-1	1 BOTTLE, PUMP in 1 CARTON (63629-9616-1) / 30 g in 1 BOTTLE, PUMP	2023-01-01

Brimonidine Tartrate: A Comprehensive Analysis of Global Suppliers and Manufacturing Landscape

Brimonidine tartrate, a synthetic α2-adrenergic agonist, has been a cornerstone in ophthalmology since its FDA approval in 1996 for treating open-angle glaucoma and ocular hypertension[8]. Its dual mechanism—reducing aqueous humor production and enhancing uveoscleral outflow—has made it a first-line therapeutic in over 50 countries[8]. Beyond glaucoma, its 0.33% gel formulation addresses persistent erythema in rosacea, expanding its clinical utility[8]. The global market for brimonidine tartrate hinges on a complex network of manufacturers, suppliers, and regulatory frameworks. This report examines the key players, regional production hubs, quality certifications, and market dynamics shaping the supply chain for this critical pharmaceutical ingredient.

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Regulatory and Quality Standards Governing Brimonidine Tartrate Production

Good Manufacturing Practices (GMP) Compliance

All brimonidine tartrate manufacturers must adhere to GMP guidelines enforced by regulatory bodies like the FDA and EMA. GMP ensures consistent quality across batches, covering raw material sourcing, production processes, and finished product testing[1][6]. For instance, Global Calcium, a USDMF and EU-GMP certified manufacturer, exemplifies compliance through exhaustive documentation and adherence to BP, EP, IP, and USP pharmacopeial standards[2]. Similarly, C2 Pharma’s manufacturing protocols emphasize traceability and purity, critical for APIs destined for ophthalmic formulations[8].

Pharmacopeial Monographs and Certifications

Suppliers often align their products with international monographs such as USP (United States Pharmacopeia), EP (European Pharmacopoeia), and IP (Indian Pharmacopoeia). Global Calcium’s brimonidine tartrate, for example, meets BP, EP, IP, and USP specifications, enabling its use in diverse markets[2]. Certifications like CEP/COS (Certification of Suitability to the Monograph of the European Pharmacopoeia) further validate compliance, as seen with PharmaCompass-listed suppliers[6]. These certifications mitigate regulatory risks for buyers by ensuring interchangeability between generic and branded formulations.

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Key Manufacturing Hubs and Regional Suppliers

India: The Generic Production Powerhouse

India dominates brimonidine tartrate production, hosting over 60% of global suppliers[4][6]. Companies like Alembic Pharmaceuticals, Lupin Ltd, and Micro Labs leverage cost-efficient synthesis and scalable infrastructure to supply both domestic and international markets. Alembic’s 0.15% and 0.1% ophthalmic solutions, approved by the FDA in 2023, underscore India’s role in democratizing access to affordable generics[3]. The country’s regulatory environment, which prioritizes abbreviated new drug applications (ANDAs), accelerates generic entry post-patent expiry.

United States: Innovation and Vertical Integration

U.S.-based manufacturers like LGM Pharma and Apotex focus on high-margin formulations and combination therapies. Apotex’s 2023 launch of brimonidine tartrate 0.1% ophthalmic solution highlights strategic investments in glaucoma therapeutics[7]. Vertical integration is common; for example, Bausch + Lomb manufactures both APIs and finished dosages, ensuring supply chain resilience[3]. The U.S. market also benefits from stringent FDA oversight, which bolsters consumer confidence in product safety.

Europe: Niche Suppliers and Specialty Pharmaceuticals

European suppliers like Farmak (Czech Republic) and Medichem (Spain) cater to regional demand for branded and specialty formulations. Farmak’s adherence to EU-GMP standards enables seamless distribution across the European Economic Area[4]. C2 Pharma, headquartered in Luxembourg, exemplifies Europe’s focus on high-purity APIs for niche applications, such as rosacea treatments[8]. The region’s emphasis on environmental sustainability also drives innovations in green chemistry for brimonidine tartrate synthesis.

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Supplier Profiles: Capabilities and Market Positioning

Global Calcium Pvt. Ltd.

A pioneer since 1979, Global Calcium manufactures brimonidine tartrate APIs compliant with BP, EP, IP, and USP standards[2]. Their vertically integrated facility in India services clients in 30+ countries, with a turnover exceeding $50 million annually. The company’s USDMF certification facilitates U.S. market entry, while its EU-WC (Written Confirmation) ensures compliance with EMA directives[6].

Apotex Inc.

Apotex’s 2022–2023 launches of 0.15% and 0.1% ophthalmic solutions position it as a leader in North American markets[3][7]. The company’s manufacturing plants in the U.S., Canada, and India enable multi-regional distribution, reducing logistical bottlenecks. Apotex’s emphasis on bioequivalence studies ensures therapeutic equivalence to reference listed drugs (RLDs) like Alphagan[5].

C2 Pharma

Specializing in high-purity APIs, C2 Pharma supplies brimonidine tartrate for both ophthalmic and dermatological applications[8]. Their synthesis process minimizes impurities to <0.1%, critical for sensitive formulations like topical gels. C2 Pharma’s partnerships with compounding pharmacies and specialty distributors underscore its flexibility in serving niche markets.

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Market Dynamics and Competitive Landscape

Patent Expirations and Genericization

The 2021–2024 patent cliff for brimonidine tartrate has intensified competition. Alembic, Apotex, and Micro Labs entered the U.S. market with AB-rated generics, achieving 30–40% price reductions compared to Allergan’s Alphagan[3][5]. The FDA’s “Orange Book” lists 14 therapeutic equivalents, fostering a buyer’s market[5]. However, first-to-file advantages remain critical; Alembic’s 2023 approval for 0.15% solution secured a six-month exclusivity period, capturing 18% market share[3].

Pricing Strategies and Cost Drivers

Brimonidine tartrate API prices range from $1,200–$1,800/kg, influenced by raw material costs (e.g., bromine derivatives) and regulatory overhead[1][6]. Indian suppliers like Tenatra Chemie offer competitive pricing at $1,100/kg, leveraging economies of scale[4]. Conversely, U.S.-based LGM Pharma charges a 20–30% premium for batch-specific CoAs (Certificates of Analysis) and accelerated shipping[4].

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Challenges in the Brimonidine Tartrate Supply Chain

Regulatory Heterogeneity

Divergent pharmacopeial standards complicate global distribution. For example, JP (Japanese Pharmacopoeia) requirements for residual solvent limits (e.g., methanol <300 ppm) necessitate separate production runs, increasing costs[6]. Suppliers like Centaur Pharma address this through modular manufacturing lines capable of switching between EP, USP, and JP monographs[6].

Counterfeit Products and Quality Risks

The proliferation of unregulated online pharmacies has escalated counterfeit risks. Fake brimonidine tartrate APIs, often containing subtherapeutic doses or contaminants, comprise 12–15% of samples tested in emerging markets[5]. PharmaCompass mitigates this by vetting suppliers via third-party audits and verifying USDMF/JDMF certifications[1][6].

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Future Outlook and Strategic Recommendations

Personalized Medicine and Novel Formulations

Advances in sustained-release technologies, such as ocular inserts and nanoparticle-based gels, will drive demand for ultra-pure APIs. Suppliers investing in continuous manufacturing (e.g., C2 Pharma’s flow chemistry platforms) will gain an edge in precision and scalability[8].

Strategic Partnerships for Market Expansion

Collaborations between API manufacturers and finished dosage producers (e.g., Lupin Ltd’s partnership with Somerset Therapeutics) optimize supply chain efficiency[5]. Emerging markets in Southeast Asia and Africa offer growth opportunities, necessitating local partnerships to navigate regulatory landscapes.

In summary, the brimonidine tartrate supply chain is characterized by robust competition, evolving regulatory demands, and innovation in drug delivery. Stakeholders must prioritize quality certifications, strategic pricing, and adaptive manufacturing to thrive in this dynamic market.

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Key Takeaways

1. India leads in generic brimonidine tartrate production, offering cost-effective APIs compliant with international standards.
2. GMP and pharmacopeial certifications (e.g., USDMF, CEP) are critical for supplier credibility and market access.
3. Patent expirations post-2021 have accelerated generic entry, reducing prices by 30–40% in key markets.
4. Counterfeit risks necessitate rigorous supplier vetting, particularly for online procurement channels.
5. Future growth hinges on personalized formulations and partnerships in emerging markets.

FAQs

1. What is the role of USDMF certification in brimonidine tartrate supply?
   USDMF (US Drug Master File) certification ensures APIs meet FDA quality standards, enabling U.S. market entry[6].

2. How do Indian suppliers maintain competitive pricing?
   Economies of scale, low labor costs, and government subsidies under India’s Pharma Vision 2020 policy reduce production expenses[4].

3. Which companies produce brimonidine tartrate for rosacea?
   C2 Pharma and Padagis Israel supply 0.33% gel formulations approved for persistent erythema[3][8].

4. What are the risks of sourcing APIs from unverified suppliers?
   Substandard APIs may contain impurities exceeding ICH limits, compromising efficacy and safety[5].

5. How do sustained-release technologies impact API demand?
   Novel delivery systems require APIs with enhanced solubility and stability, driving demand for high-purity suppliers like Global Calcium[2][8].

References

1. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/brimonidine-tartrate
2. https://www.globalcalcium.com/products/brimonidine-tartrate
3. https://pharsight.greyb.com/ingredient/brimonidine-tartrate-patent-expiration
4. https://pharmaoffer.com/api-excipient-supplier/ocular-preparations/brimonidine
5. https://www.drugs.com/availability/generic-combigan.html
6. https://www.pharmacompass.com/manufacturers-suppliers-exporters/brimonidine-tartrate
7. https://www.apotex.com/us/about-us/news/2023/09/05/apotex-corp.-launches-brimonidine-tartrate-ophthalmic-solution-0.1-in-the-united-states
8. https://c2pharma.com/apis/brimonidine-tartrate/