Suppliers and packagers for ASHLYNA

ASHLYNA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Glenmark Pharms Ltd	ASHLYNA	ethinyl estradiol; levonorgestrel	TABLET;ORAL	203163	ANDA	A-S Medication Solutions	50090-2097-0	1 KIT in 1 KIT (50090-2097-0)	2015-02-23
Glenmark Pharms Ltd	ASHLYNA	ethinyl estradiol; levonorgestrel	TABLET;ORAL	203163	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-646-93	2 POUCH in 1 CARTON (68462-646-93) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK (68462-646-91)	2015-02-23

Suppliers for the Pharmaceutical Drug: Ashlyna

Last updated: July 29, 2025

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Introduction

Ashlyna is a portfolio-brand contraceptive tablet used primarily for preventing pregnancy. As a combined oral contraceptive, it contains ethinylestradiol and desogestrel, offering a hormonal approach to contraception. With increasing global demand for contraceptive options, identifying reliable suppliers for Ashlyna is critical for healthcare providers, pharmaceutical distributors, and manufacturers. This article explores the key suppliers, the manufacturing landscape, and considerations for sourcing Ashlyna.

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Manufacturers of Ashlyna

Ashlyna is developed and produced by various pharmaceutical companies, with the primary manufacturer being Hikma Pharmaceuticals. Hikma is a leading global pharmaceutical company specializing in generic and specialty medicines, including hormonal contraceptives.

Hikma Pharmaceuticals

• Overview: Hikma manufactures Ashlyna across multiple regions, including Europe and the Middle East. Their robust quality standards and extensive production capacity make them a primary source for Ashlyna.
• Production Sites: Hikma's manufacturing facilities in countries such as Portugal, Jordan, and the UK are certified by regulatory agencies like the EMA and the FDA, ensuring adherence to Good Manufacturing Practices (GMP).

Other Potential Manufacturers

While Hikma is the most recognized producer, other pharmaceutical companies may produce similar combination contraceptives, often under different brand names with comparable formulations. However, for Ashlyna specifically, Hikma remains the central licensed manufacturer.

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Authorized Distributors and Suppliers

Authorized distributors act as intermediaries between manufacturers and end-users, including pharmacies and healthcare organizations. Reliable suppliers are crucial to ensure medication safety, potency, and regulatory compliance.

Direct Purchase from Manufacturer

• Hikma's Distribution Channels: Hikma supplies Ashlyna directly to licensed distributors and pharmaceutical wholesalers. Healthcare providers seeking genuine products should prioritize purchasing through authorized channels to avoid counterfeit risks.
• Regional Availability: In Europe, Hikma distributes Ashlyna through regional partners and authorized healthcare distributors.

Major International Pharmaceutical Wholesalers

Numerous global and regional pharmaceutical wholesalers distribute Ashlyna:

• McKesson Corporation: A leading healthcare company in North America, McKesson supplies generic contraceptives to pharmacies and clinics, including products from Hikma or similar formulations.
• AmerisourceBergen: Supplies a broad selection of reproductive health medications, including hormonal contraceptives.
• Gupta Pharmacies: Prominent in India, they serve as significant distributors for generic contraceptives.
• Veredus Laboratories: Regional distributor with access to contraceptive products for the Middle East.

Availability varies depending on the region's regulatory approvals and licensing agreements.

Regional and Local Distributors

In addition to global wholesalers, regional distributors often provide Ashlyna to local pharmacies, clinics, and hospitals. Regulatory awareness and quality assurance are critical when sourcing from these channels.

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Regulatory and Certification Considerations

Sourcing Ashlyna necessitates compliance with regional health authority regulations — notably the EMA (European Medicines Agency), FDA (U.S. Food & Drug Administration), and MHRA (UK Medicines and Healthcare products Regulatory Agency). Certificates of Analysis (CoA), Good Manufacturing Practice (GMP) compliance, and traceability are essential factors in choosing suppliers.

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Market Channels and Procurement Strategies

Official Procurement Channels

• Government tenders: Many governments procure contraceptives via competitive bids from licensed suppliers.
• Hospital formularies: Hospitals often source Ashlyna through approved pharmaceutical pipelines.
• Pharmacy chains: Chain pharmacies acquire medications through registered pharmaceutical distributors with direct links to manufacturers.

Private Procurement

Private clinics and pharmacies leverage authorized wholesalers and regional distributors. Digital platforms for wholesale procurement are increasingly common, facilitating access to licensed drugs.

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Key Considerations for Sourcing Ashlyna

• Authenticity: Confirm genuine licensed sources to avoid counterfeit products.
• Regulatory approvals: Ensure products meet regional standards such as EMA, FDA, or WHO prequalification.
• Supply chain integrity: Verify traceability, temperature controls, and storage conditions.
• Pricing and supply stability: Establish relationships with diversified suppliers to mitigate supply disruptions.

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Conclusion

Securing reliable suppliers for Ashlyna involves engaging with authorized manufacturers like Hikma Pharmaceuticals and reputable regional and global distributors. The emphasis should be on maintaining supply chain integrity, complying with regional regulations, and ensuring product authenticity. Given the critical nature of contraceptive medications, healthcare providers must prioritize sourcing from certified suppliers to safeguard patient safety and therapeutic efficacy.

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Key Takeaways

• Hikma Pharmaceuticals is the primary licensed manufacturer of Ashlyna, with manufacturing facilities certified to international GMP standards.
• Authorized distributors such as McKesson, AmerisourceBergen, and regional wholesalers are essential for legitimate procurement.
• Regulatory compliance and product verification are crucial in sourcing Ashlyna to prevent counterfeit risks and ensure safety.
• Global procurement strategies must adapt to regional regulations, ensuring traceability, quality, and reliable supply.
• Diversification of suppliers and adherence to official procurement channels mitigate risks related to supply chain disruptions.

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FAQs

1. Who manufactures Ashlyna?
   Ashlyna is primarily manufactured by Hikma Pharmaceuticals, with production facilities certified to international GMP standards.

2. How can I verify the authenticity of Ashlyna?
   Verify products through authorized suppliers, check batch numbers on official regulatory websites, and ensure certificates of analysis (CoA) are available.

3. Are there regional differences in sourcing Ashlyna?
   Yes. Availability depends on regional licensing and distribution partnerships. Always source from licensed distributors compliant with local regulations.

4. Can I purchase Ashlyna directly from Hikma?
   Generally, direct purchasing is limited to licensed healthcare providers and authorized distributors; individual consumers should buy through licensed pharmacies.

5. What are the risks of sourcing from unverified suppliers?
   Risks include counterfeit medication, substandard quality, ineffective treatment, and regulatory non-compliance, posing safety concerns for patients.

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References

1. Hikma Pharmaceuticals. “About Us.” available at Hikma official website.
2. European Medicines Agency. “Manufacturing Authorization and GMP Compliance.” EMA guidelines.
3. U.S. FDA. “Approved Drug Products with Therapeutic Equivalence Evaluations.”
4. World Health Organization. “Guidelines for the Quality of Pharmaceutical Products.”