Suppliers and packagers for loryna

loryna

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Xiromed	LORYNA	drospirenone; ethinyl estradiol	TABLET;ORAL	079221	ANDA	Bryant Ranch Prepack	63629-2336-1	3 CARTON in 1 CARTON (63629-2336-1) / 1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK	2018-10-09
Xiromed	LORYNA	drospirenone; ethinyl estradiol	TABLET;ORAL	079221	ANDA	Xiromed, LLC.	70700-114-85	3 BLISTER PACK in 1 CARTON (70700-114-85) / 1 KIT in 1 BLISTER PACK	2022-06-09

Suppliers for the Pharmaceutical Drug: LORYNA

Last updated: August 13, 2025

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Introduction

LORYNA is a prescription oral contraceptive combining drospirenone and ethinyl estradiol, primarily marketed for birth control and managing hormonal imbalances. As a branded product under Bayer, the drug’s supply chain involves various pharmaceutical manufacturers, authorized distributors, and global suppliers. Understanding the landscape of LORYNA’s suppliers is critical for stakeholders across healthcare, supply chain management, and regulatory sectors aiming to ensure consistent availability, quality assurance, and compliance.

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Manufacturers of LORYNA

Bayer AG oversees the production, marketing, and distribution of LORYNA. As a global healthcare company, Bayer manages multiple manufacturing facilities authorized to produce LORYNA or its active pharmaceutical ingredients (APIs). While Bayer holds the patent and regulatory approval, specific manufacturing processes may involve third-party Contract Manufacturing Organizations (CMOs), especially in regions where Bayer licenses or sources APIs.

The primary manufacturing facilities for Bayer engage in:

• API Production: Sikora Pharmaceuticals (India), Torrent Pharmaceuticals (India), and other regional API manufacturers often supply drospirenone and ethinyl estradiol (EE).
• Finished Dosage Form Production: Bayer’s own facilities in Germany, USA, or collaborating CMOs in lower-cost manufacturing regions produce the final tablets.

Note: Specific manufacturing site details for LORYNA are proprietary; however, public records and regulatory filings suggest active involvement of regional CMOs, especially for oral contraceptives.

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Active Pharmaceutical Ingredient (API) Suppliers

The API market for drospirenone and ethinyl estradiol is highly concentrated, with several key suppliers providing high-quality APIs to major pharmaceutical companies, including Bayer.

1. Drospirenone API Suppliers:

   • Torrent Pharmaceuticals (India): A prominent producer of drospirenone, supplying APIs to multiple contraceptive brands.
   • Sikora Pharmaceuticals (India): Manufactures drospirenone with WHO-GMP certification, exporting to global markets.
   • Pfizer (USA/Europe): Although primarily focused on other hormone APIs, Pfizer’s API manufacturing division supplies drospirenone for various formulations.

2. Ethinyl Estradiol API Suppliers:

   • Shenzhen Wuzhou Pharmaceutical (China): Major producer of EE.
   • Hainan Baini Pharmaceutical (China): Supplies high-purity EE for international markets.
   • Sino Biopharmaceutical (Hong Kong/China): Another significant API supplier of EE.

Quality and Regulatory Compliance:
All APIs supplied must comply with stringent cGMP standards, typically verified through Certificate of Analysis (CoA) documentation. Regulatory agencies, such as the FDA or EMA, routinely audit API suppliers, which influences Bayer’s sourcing decisions.

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Distribution and Authorized Distributors

Bayer employs a global network of authorized distributors, warehouses, and regional partners to supply LORYNA across multiple territories. These include:

• Regional Distributors: Local pharmaceutical wholesalers, hospital pharmacies, and licensed pharmacies acting as intermediaries in North America, Europe, Asia-Pacific, and Latin America.
• Licensed Pharmacies: Retail chains where prescribers directly dispense LORYNA to patients.

Bayer’s distribution strategy emphasizes supply chain integrity, with certified logistics providers adhering to cold chain and storage standards. Additionally, Bayer maintains a robust inventory management system to prevent shortages.

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Global Supply Chain Dynamics and Challenges

While Bayer maintains control over its core manufacturing, the global supply chain for LORYNA relies heavily on APIs sourced from Asia, especially India and China. This dependence exposes the supply chain to risks including:

• Regulatory Changes: Local government policies or export restrictions in API-producing countries.
• Quality Variability: Ensuring consistent API quality amid diverse suppliers.
• Supply Disruptions: Impacted by geopolitical issues, pandemic effects, or transportation bottlenecks.

To mitigate such risks, Bayer and similar companies diversify API suppliers and implement stringent quality assurance protocols.

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Regulatory Considerations

Manufacturers and suppliers of LORYNA must comply with national and international regulatory standards for pharmaceuticals. This includes obtaining approvals from agencies such as the FDA, EMA, or MHRA and maintaining cGMP compliance. Such approvals determine the eligibility of suppliers to participate in the global supply chain.

Regulatory audits are crucial; any non-compliance at API manufacturing sites can jeopardize the entire supply chain, leading to shortages or product recalls.

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Future Outlook

Emerging trends influencing LORYNA suppliers include:

• Biotech API Development: Shift toward biosynthesis of hormones for improved safety and consistency.
• Regional Manufacturing Expansion: Increasing local API production in Europe and North America to reduce dependence on Asian suppliers.
• Supply Chain Digitization: Use of blockchain and IoT to enhance traceability and transparency.

These developments aim to strengthen supply resilience and ensure consistent availability of LORYNA worldwide.

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Key Takeaways

• Bayer manages LORYNA's production, sourcing APIs primarily from Indian and Chinese manufacturers known for high API standards.
• The supply chain hinges on API quality, regulatory approval, and global logistics, with notable reliance on Asian suppliers.
• Ensuring supply continuity involves diversifying sources, stringent quality checks, and adherence to international regulations.
• Geopolitical and pandemic-related disruptions remain significant risks.
• The future landscape indicates a move toward regional API manufacturing and increased supply chain digitization.

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FAQs

1. Who are the primary API suppliers for drospirenone used in LORYNA?
Torrent Pharmaceuticals (India), Sikora Pharmaceuticals (India), and Pfizer are notable API suppliers of drospirenone, delivering consistent, high-quality APIs globally.

2. Does Bayer outsource the manufacturing of LORYNA or produce it in-house?
Bayer primarily oversees production but relies on third-party CMOs for manufacturing certain dosage forms and APIs, especially in regions with cost advantages.

3. How does supply chain disruption affect the availability of LORYNA?
Disruptions in API supply or logistics can lead to shortages, impacting patient access. Regulatory restrictions and pandemic-related delays are the primary risks.

4. Are there any regional manufacturing facilities for LORYNA?
While specific facilities are proprietary, Bayer’s strategic regional manufacturing, including facilities in Europe and North America, helps distribute LORYNA globally.

5. How does regulatory compliance ensure the quality of suppliers?
Regulatory agencies require rigorous audits and certifications (e.g., cGMP compliance), ensuring APIs and finished drugs meet safety and efficacy standards.

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Sources

[1] Bayer. "LORYNA Prescribing Information." 2022.
[2] U.S. Food & Drug Administration (FDA). "Approved Drug Listing."
[3] PharmaCompany Reports. API Production and Supply Chain Insights, 2022.
[4] World Health Organization (WHO). "Guidelines on Good Manufacturing Practices."
[5] Indian Pharmaceutical Alliance Reports. API Supplier Directory, 2021.