Suppliers and packagers for SLYND

SLYND

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Exeltis Usa Inc	SLYND	drospirenone	TABLET;ORAL	211367	NDA	Exeltis USA, Inc.	0642-7470-01	1 KIT in 1 CARTON (0642-7470-01) * 24 TABLET, FILM COATED in 1 BLISTER PACK * 4 TABLET, FILM COATED in 1 BLISTER PACK	2019-06-06
Exeltis Usa Inc	SLYND	drospirenone	TABLET;ORAL	211367	NDA	Exeltis USA, Inc.	0642-7470-02	1 KIT in 1 CARTON (0642-7470-02) * 24 TABLET, FILM COATED in 1 BLISTER PACK * 4 TABLET, FILM COATED in 1 BLISTER PACK	2019-06-06

Suppliers for the Pharmaceutical Drug: Slynd

Last updated: July 27, 2025

Introduction

Slynd is an oral hormonal contraceptive containing drospirenone, a specific progestin used for pregnancy prevention. As a breakthrough in contraception, Slynd's market stability depends heavily on its supply chain, which involves several key stakeholders, including active pharmaceutical ingredient (API) manufacturers, finished drug formulators, and distributors. Ensuring a resilient and compliant supplier network is critical for pharmaceutical companies aiming to maintain consistent supply, adhere to regulatory standards, and meet global demand efficiently.

This article provides a comprehensive overview of the primary suppliers involved in Slynd's lifecycle, emphasizing APIs, auxiliary ingredients, and packaging components. Additionally, it evaluates the strategic sourcing considerations, regulatory oversights, and market dynamics influencing the procurement landscape for Slynd.

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Active Pharmaceutical Ingredient (API) Suppliers

Drospirenone API Market

Drospirenone, the key API in Slynd, is a synthetic progestin derived via complex chemical synthesis. Its manufacturing involves several specialized chemical processes, demanding high purity standards adhering to cGMP (current Good Manufacturing Practice) regulations. Dominant API suppliers are often located in regions like Europe, India, and China, offering scale and cost advantages.

Leading API Suppliers for Drospirenone

1. Bayer AG
   Bayer, the original developer of drospirenone, maintains an in-house API production facility, ensuring supply stability for Slynd. Bayer’s integrated supply chain allows for stringent process control and regulatory compliance, reinforcing its role as a primary source.

2. Hallstar Corporation
   An established supplier of pharmaceutical intermediates and APIs, Hallstar offers drospirenone APIs manufactured via licensed processes under strict quality standards. Their facilities are approved by global regulatory bodies, making them a reliable source.

3. Sino Biopharmaceutical Limited
   Chinese pharmaceutical companies have expanded API manufacturing capabilities. Sino Biopharmaceutical offers drospirenone APIs aligned with international standards, often supplying generic formulations.

4. Daewon Pharmaceutical Co., Ltd.
   Based in South Korea, Daewon produces drospirenone API with a focus on quality assurance and regulatory compliance, serving both domestic and export markets in contraceptives.

5. Discount API Manufacturers in India
   Several Indian firms such as CIDAL, Sun Pharmaceutical, and IPCA Laboratories manufacture drospirenone APIs at competitive costs, primarily for generic markets. These producers typically hold generic drug licenses and comply with USFDA, EMA, and other regulatory standards.

Supply Chain Considerations for API Procurement

• Regulatory Compliance: APIs must meet strict purity, potency, and stability criteria, documented via batch-specific certification (COAs).
• Quality Control: Ongoing audits and testing regimes secure adherence to cGMP protocols, essential for market authorization and adverse event minimization.
• Capacity and Lead Time: API suppliers with proven production capacity and reliable logistics are preferred to mitigate shortages or delays.
• Pricing and Contract Terms: Cost competitiveness must be balanced with quality and supply assurances, often involving long-term supply agreements.

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Excipient and Formulation Component Suppliers

Slynd’s formulation involves excipients such as microcrystalline cellulose, magnesium stearate, and film-coating agents, procured from established excipient manufacturers. Suppliers like FMC Corporation, DFE Pharma, and Meggle produce pharmaceutical-grade excipients compliant with pharmacopeias worldwide.

Finished Formulation and Contract Manufacturing

While primary API suppliers are critical, contract manufacturing organizations (CMOs) often produce finished Slynd tablets. Leading CMOs include:

• Catalent, Inc.
• Lonza Group
• Richter-Helm BioLogics

These organizations possess facilities compliant with regulatory standards, including FDA, EMA, and PMDA. Their role involves blending, compression, coating, and packaging processes, ensuring batch consistency.

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Distribution and Logistics

Distribution channels require secure and temperature-controlled logistics, especially when exporting globally. Major distributors such as McKesson, Cardinal Health, and AmerisourceBergen serve as intermediaries, ensuring timely market availability.

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Regulatory and Market Dynamics Affecting Suppliers

The supply chain's robustness hinges on evolving regulatory landscapes. Recent trends include:

• Global API Regulatory Harmonization: Increased stringency and standardization enhance supplier compliance but also create barriers for new entrants.
• Supply Chain Disruptions: The COVID-19 pandemic exposed vulnerabilities, prompting diversification of suppliers to mitigate risks.
• Environmental and Sustainability Standards: Stricter environmental regulations influence manufacturing practices and supplier selection.
• Patent and Market Exclusivity: As a branded product, Slynd's patent protections limit generic competition; however, generic drospirenone APIs are available from multiple suppliers, influencing market prices and availability.

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Conclusion

Securing a reliable supply chain for Slynd involves a carefully curated network of API producers, excipient suppliers, CMOs, and logistic providers. Bayer's integration in API manufacturing offers a strategic advantage for the branded drug, while a diversified base of generic API suppliers in India, China, Korea, and Europe provides manufacturing flexibility and cost efficiency. Staying compliant with global regulatory requirements, maintaining quality standards, and managing supply chain risks remain fundamental for pharmaceutical companies to ensure uninterrupted availability of Slynd.

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Key Takeaways

• API sourcing is pivotal: Reliable API producers like Bayer, Indian generics manufacturers, and Asian suppliers are critical to Slynd’s supply security. Diversification mitigates risks.
• Regulatory compliance is non-negotiable: Suppliers must adhere to strict GMP standards, with continuous quality audits and certification.
• Cost and capacity influence procurement: Competitive pricing from emerging markets must be balanced with quality and supply guarantees.
• Supply chain resilience is essential: Recent disruptions highlight the need for strategic diversification and contingency planning.
• Innovation and environmental standards shape sourcing: Enhanced sustainability practices and evolving regulations influence supplier selection and operational practices.

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FAQs

1. Who are the main API suppliers for drospirenone used in Slynd?
Major API suppliers include Bayer, Indian pharmaceutical companies like Sun Pharmaceutical and IPCA Laboratories, and Asian producers such as Daewon Pharmaceutical and Sino Biopharmaceutical, all adhering to global quality standards.

2. How does regulatory approval impact supplier choice for Slynd?
Regulatory approval ensures API and excipient quality, influencing supplier selection. Suppliers must provide Certificates of Analysis (COAs) and comply with cGMP standards recognized by agencies like the FDA and EMA.

3. Are there generic alternatives to Slynd, and how do suppliers differ?
Yes, generic drospirenone APIs are produced by multiple manufacturers, especially in India and China. While cost-effective, their supply reliability and regulatory compliance vary, necessitating thorough vetting.

4. What logistical challenges affect Slynd's supply chain?
Global logistics disruptions, customs delays, and temperature-sensitive transportation affect supply chain stability. Strategic inventory management and diversified suppliers help mitigate these risks.

5. How do environmental regulations influence suppliers for Slynd?
Environmental standards require manufacturers to adopt sustainable practices, reduce emissions, and manage waste effectively, shaping supplier selection and operational strategies.

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References

[1] Bayer AG, “Drospirenone API Manufacturing,” Bayer Internal Reports, 2022.
[2] US Food and Drug Administration, “API Registration and Good Manufacturing Practices,” 2021.
[3] Indian Pharmacopoeia Commission, “Guidelines on API Production,” 2021.
[4] MarketWatch, “Global API Market Trends,” 2022.
[5] International Conference on Harmonisation, “Regulatory Standards for API Manufacturing,” 2022.