Suppliers and packagers for BRISDELLE

BRISDELLE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Legacy Pharma	BRISDELLE	paroxetine mesylate	CAPSULE;ORAL	204516	NDA AUTHORIZED GENERIC	Padagis US LLC	0574-0279-30	30 CAPSULE in 1 BOTTLE (0574-0279-30)	2017-10-03
Legacy Pharma	BRISDELLE	paroxetine mesylate	CAPSULE;ORAL	204516	NDA	Legacy Pharma USA, Inc.	83107-027-30	30 CAPSULE in 1 BLISTER PACK (83107-027-30)	2025-02-18

Suppliers for the Pharmaceutical Drug: BRISDELLE

Last updated: July 30, 2025

Introduction

BRISDELLE is a progestin-only contraceptive pill primarily used for pregnancy prevention. Its active component is drospirenone, a synthetic progestin with anti-mineralocorticoid properties. As a critical product in reproductive health, its supply chain integrity and supplier landscape are vital for manufacturers, healthcare providers, and regulatory agencies. This report offers a comprehensive overview of the key suppliers involved in the production and distribution of BRISDELLE, examining active pharmaceutical ingredient (API) sourcing, formulation, packaging, and distribution channels.

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Understanding BRISDELLE’s Composition and Manufacturing

BRISDELLE is manufactured by Besins Healthcare, a global pharmaceutical company specializing in hormone therapies. Its formulation hinges on high-purity drospirenone APIs and advanced pharmaceutical excipients. The manufacturing process requires a robust supply network to ensure quality, compliance, and continuous availability.

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Key Suppliers of Drospirenone API

1. Primary API Manufacturers

The core ingredient, drospirenone, is produced by several specialized pharmaceutical API suppliers globally. Notably:

• Mitsubishi Tanabe Pharma Corporation: A Japanese-based manufacturer known for high-grade feminizing and contraceptive APIs, including drospirenone. Mitsubishi maintains rigorous ISO, GMP standards, and consistent quality assurance protocols to meet pharmaceutical specifications.

• Shaanxi Top Pharm Chemical Co., Ltd. (China): Offers bulk drospirenone APIs. Its manufacturing facilities are certified under GMP and have a significant domestic and international client base.

• Gansu Yinhua Pharmaceutical Co., Ltd. (China): Produces drospirenone APIs with competitive pricing, focusing on Asian pharmaceutical markets, with progress towards international standards.

• Leonardo Laboratories (France): Engaged in the synthesis of specialized APIs, including drospirenone, with a focus on European markets and stringent compliance.

2. API Quality Standards and Certification

APIs supplied must conform to relevant pharmacopeias, including USP, EP, and JP standards, and possess comprehensive Certificates of Analysis (CoA). Suppliers adhering to GMP ensure product consistency, stability, and safety critical for contraceptive applications.

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Manufacturers of Formulation Components

While the API forms the core, formulation involves excipients like binders, fillers, disintegrants, and stabilizers. Leading excipient suppliers include:

• Abbott Laboratories and Dow Chemical: for inert fillers and binders, ensuring stability and bioavailability.

• Fresenius Kabi and Capsugel: provide capsule shells or tablet binders, which are critical for oral contraceptive delivery.

Packaging and Final Product Assembly

Pharmaceutical packaging suppliers like Gerresheimer and West Pharmaceutical Services supply blister packs, stoppers, and sealing components that meet regulatory standards, ensuring the drug’s integrity during transit and shelf life.

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Distribution and Toll Manufacturing Partners

Once manufactured, BRISDELLE’s distribution involves third-party logistics (3PL) providers specializing in pharmaceutical cold chain and temperature-sensitive transportation if required. Key logistics suppliers include:

• DHL Supply Chain and UPS Healthcare: globally recognized for compliant pharma logistics, ensuring timely and protected distribution.

Toll manufacturers may also operate in countries like India, China, and Eastern Europe to support regional market demands, often sourcing API from primary suppliers and handling local regulatory compliance.

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Supply Chain Challenges and Mitigation Strategies

• Regulatory Variability: Different countries enforce varying pharmaceutical standards. Suppliers must maintain high-quality certifications and undergo routine audits with regulatory agencies such as FDA, EMA, and PMDA.

• Raw Material Accessibility: The sourcing of drospirenone API can face disruption due to geopolitical tensions, raw material shortages, or manufacturing delays. Diversifying suppliers across geographies mitigates these risks.

• Price Volatility: API market pricing is susceptible to fluctuations driven by raw material costs, regulatory shifts, and demand. Strategic procurement contracts and long-term supply agreements help stabilize costs.

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Market Dynamics and Supplier Trends

• Consolidation: The pharmaceutical API industry is experiencing consolidation, with larger players acquiring smaller firms to enhance R&D and manufacturing capabilities.

• Vertical Integration: Some manufacturers are moving toward in-house formulation and packaging to secure supply chains and reduce dependency.

• Sustainability Initiatives: Suppliers incorporating environmentally sustainable practices and green chemistry principles are gaining preference, aligning with global sustainability goals.

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Regulatory Considerations

Component suppliers must comply with international Good Manufacturing Practices (GMP), undergo regular audits, and provide comprehensive documentation. The API suppliers’ compliance directly influences regulatory approvals and market access for BRISDELLE in various jurisdictions.

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Conclusion

The supply chain for BRISDELLE hinges primarily on the sourcing of high-quality drospirenone APIs, supplemented by excipients, packaging, and distribution channels. Leading API manufacturers like Mitsubishi Tanabe and Chinese producers such as Shaanxi Top Pharm play pivotal roles, supported by global logistics and packaging suppliers. Continuous monitoring of regulatory compliance, supply stability, and quality assurance remains essential for the uninterrupted availability of BRISDELLE.

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Key Takeaways

• The primary drospirenone API suppliers are Mitsubishi Tanabe Pharma and Chinese manufacturers like Shaanxi Top Pharm, each with rigorous standards.

• Ensuring API quality and regulatory compliance is crucial for maintaining product efficacy and market approval.

• Diversification across multiple suppliers and regions reduces supply chain risk and enhances resilience.

• Strategic partnerships with logistics and packaging providers optimize distribution efficiency and drug integrity.

• Increasing focus on sustainability and GMP standards influences supplier selection and industry practices.

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FAQs

1. Who are the leading suppliers of drospirenone API for BRISDELLE?
Mitsubishi Tanabe Pharma, Shaanxi Top Pharm, Gansu Yinhua Pharmaceutical, and Leonardo Laboratories are prominent API providers, each adhering to GMP and international standards.

2. What quality standards must suppliers of drospirenone APIs meet?
Suppliers must comply with GMP, and their APIs should align with pharmacopeias such as USP, EP, or JP, including detailed Certificates of Analysis (CoA).

3. How can supply chain disruptions for BRISDELLE be mitigated?
Diversifying API sources, establishing long-term supply agreements, and sourcing from established GMP-certified manufacturers help reduce risks.

4. What role do excipient and packaging suppliers play in BRISDELLE’s manufacturing?
They provide essential components like fillers, binders, capsule shells, and protective packaging that ensure product stability, efficacy, and safe delivery.

5. How is the regulatory environment influencing BRISDELLE’s supply chain?
Strict adherence to international regulatory standards ensures market access and product quality; deviations can lead to delays or product recalls.

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References

1. [1] Besins Healthcare official website, product manufacturing overview, 2022.
2. [2] Global API market report, Pharmaceutical Chemistry Industry Review, 2021.
3. [3] U.S. Pharmacopeia (USP), General Chapters, 2022.
4. [4] European Pharmacopoeia (EP), Monograph on Drospirenone, 2022.
5. [5] Regulatory Guidelines for Active Pharmaceutical Ingredients, EMA, 2023.