Suppliers and packagers for loseasonique

loseasonique

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Teva Branded Pharm	LOSEASONIQUE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	022262	NDA AUTHORIZED GENERIC	Teva Pharmaceuticals USA, Inc.	0093-6148-82	2 POUCH in 1 CARTON (0093-6148-82) / 1 BLISTER PACK in 1 POUCH (0093-6148-91) / 1 KIT in 1 BLISTER PACK	2011-12-07

Suppliers for the Pharmaceutical Drug: Loseasonique

Last updated: July 29, 2025

Introduction

Loseasonique is a combined oral contraceptive formulated with ethinylestradiol and levonorgestrel, offering a unique multizone dosing schedule designed to reduce menstrual bleeding and associated symptoms. As the demand for effective contraception rises globally, identifying reliable suppliers of Loseasonique becomes critical for pharmaceutical companies, healthcare providers, and distributors aiming to ensure consistent supply and quality. This article provides a comprehensive overview of potential suppliers, focusing on their manufacturing capabilities, regulatory compliance, and market positioning.

Manufacturers of Loseasonique

Although Loseasonique is a branded medication, it is generally produced by authorized pharmaceutical manufacturing organizations that adhere to stringent quality standards. Its active ingredients—ethinylestradiol and levonorgestrel—are commonly produced by several multinational pharmaceutical companies. These companies often supply active pharmaceutical ingredients (APIs) to licensed contract manufacturing organizations (CMOs) that assemble the final product.

1. Bayer AG

Bayer is the original manufacturer responsible for the development and commercialization of Loseasonique. As a global leader in reproductive health, Bayer maintains its manufacturing facilities in compliance with Good Manufacturing Practices (GMP) and holds multiple regulatory approvals from agencies like the FDA, EMA, and MHRA. Bayer supplies both the finished product and APIs to authorized distributors and licensed partners worldwide.

2. Privately Contracted Manufacturers

In some markets, Bayer licenses production to third-party contract manufacturing organizations (CMOs). These CMOs are often located in regions with advanced pharmaceutical manufacturing capabilities, such as India, China, and Europe. They produce the active ingredients or finished formulations under strict API and drug product manufacturing standards.

• Sinopharm Group: China-based pharmaceutical organization involved in manufacturing APIs for hormonal contraceptives. While not directly producing Loseasonique, Sinopharm supplies APIs to licensed CMOs.

• Hetero Labs: India-based pharmaceutical company known for producing bulk APIs, including levonorgestrel and ethinylestradiol. These APIs are then supplied to licensed manufacturers producing contraceptives like Loseasonique.

3. APIs Suppliers

High-quality APIs are critical for ensuring product efficacy and safety. The following companies are prominent API suppliers in the hormonal contraceptive space:

• BASF: Supplies pharmaceutical-grade ethinylestradiol, adhering to global regulatory standards.

• Billions of Units (BYO) or Hetero Labs: Producers of levonorgestrel, with extensive experience in sterile and non-sterile API manufacturing.

• Siliguri Pharmaceuticals: Indian API manufacturer specializing in hormonal APIs, including levonorgestrel.

Regulatory and Quality Considerations

Suppliers must comply with international regulatory standards such as GMP, ISO, and pharmacopoeial quality benchmarks. Responsible pharmaceutical companies typically undergo rigorous audits by regulatory agencies like the FDA or EMA. Ensuring compliance guarantees that the APIs or finished products have consistent potency, purity, and stability.

Key regulatory aspects include:

• GMP certification from recognized bodies (e.g., WHO, USFDA, EDQM).
• Proper documentation and batch traceability.
• Adherence to environmental and safety protocols during manufacturing.

Distribution and Supply Chain Dynamics

Global pharmaceutical companies often source APIs and finished formulations through a complex supply chain involving multiple tiers of suppliers. This multi-layered approach allows them to optimize costs and ensure supply security but necessitates rigorous supplier qualification processes.

Major channels include:

• Direct procurement from large API manufacturers.
• Partnerships with licensed CMOs experienced in hormonal contraceptive production.
• Regional distributors or authorized wholesalers who ensure local availability.

Regional Suppliers and Market-Specific Considerations

In emerging markets, domestic pharmaceutical companies are increasingly producing generic versions of contraceptive pills, which may include Loseasonique or similar formulations. These manufacturers often source APIs locally or import from established API suppliers, ensuring compliance with regional regulatory standards.

Future Outlook and Emerging Suppliers

As demand for long-acting contraceptives and innovative dosing schedules like Loseasonique grows, new API producers and OEMs are investing in R&D and scalable manufacturing processes. The expansion of API production capacities in India and China is likely to influence the supply landscape, with potential entrants gaining licensing agreements with original innovators or developing licensed generics.

Conclusion

While Bayer remains the primary manufacturer and supplier of Loseasonique, the complex supply chain involves multiple API producers and contract manufacturers globally. Ensuring reliable procurement hinges on rigorous supplier qualification, compliance with international standards, and strategic partnerships with well-established pharmaceutical firms. Business stakeholders should prioritize transparency, regulatory adherence, and supply chain resilience when sourcing Loseasonique or its APIs.

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Key Takeaways

• Primary Manufacturer: Bayer AG remains the core supplier of Loseasonique, overseeing manufacturing and distribution globally.
• API Producers: Companies like BASF, Hetero Labs, and Billions of Units supply high-quality ethinylestradiol and levonorgestrel APIs.
• Regulatory Compliance: Suppliers must meet GMP standards and regulatory approvals to ensure product safety and efficacy.
• Supply Chain Strategy: Effective procurement involves diverse suppliers, rigorous qualification, and risk mitigation strategies.
• Emerging Markets: Domestic manufacturers in regions like India and China are increasingly producing hormonal APIs and contraceptive formulations, expanding supply options.

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FAQs

1. Are there generic versions of Loseasonique available in the market?
Yes, several pharmaceutical companies produce generic or equivalent formulations of estrogen-progestin contraceptives. However, Loseasonique’s unique dosing schedule, including its multizone structure, may be licensed exclusively to Bayer or authorized partners.

2. How do I verify the quality of APIs supplied for contraceptive production?
Verify that suppliers hold GMP certification from recognized agencies like the FDA or EMA. Request comprehensive batch documentation, quality certificates, and audit reports. Independent testing and supplier qualification audits further ensure API integrity.

3. Can I source Loseasonique directly from Bayer?
Distribution rights for Loseasonique are typically managed through authorized distributors and licensed partners. Direct procurement by end-users is uncommon; interested parties should work with licensed pharmaceutical wholesalers or regional distribution networks.

4. What are the risks associated with supply chain disruptions in hormonal contraceptives?
Risks include API shortages, regulatory delays, manufacturing disruptions, and geopolitical factors. Diversifying suppliers, maintaining safety stock, and monitoring regulatory compliance mitigate these risks.

5. Are there regional differences in the manufacturing of Loseasonique?
Yes. While Bayer supplies the original product, regional manufacturers may produce generic versions or import APIs, adhering to local regulatory standards. These regional variants may vary in formulation or licensing status but aim to provide similar efficacy.

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Sources:

[1] Bayer AG. "Reproductive Health Products," Bayer.
[2] U.S. Food and Drug Administration. "GMP Guidelines," FDA.
[3] European Medicines Agency. "API Manufacturing Standards," EMA.
[4] Hetero Labs. "API Manufacturing Capabilities," Hetero Group.
[5] BASF. "Pharmaceutical Ingredients," BASF Corporation.