Suppliers and packagers for ayuna

ayuna

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aurobindo Pharma	AYUNA	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	206866	ANDA	Afaxys Pharma, LLC	50102-230-23	3 POUCH in 1 CARTON (50102-230-23) / 1 BLISTER PACK in 1 POUCH (50102-230-21) / 1 KIT in 1 BLISTER PACK	2016-09-23
Aurobindo Pharma	AYUNA	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	206866	ANDA	Aurobindo Pharma Limited	65862-848-88	3 POUCH in 1 CARTON (65862-848-88) / 1 BLISTER PACK in 1 POUCH (65862-848-28) / 1 KIT in 1 BLISTER PACK	2016-09-23
Aurobindo Pharma	AYUNA	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	206866	ANDA	Aurobindo Pharma Limited	65862-848-92	6 POUCH in 1 CARTON (65862-848-92) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK	2016-09-23

Suppliers for the Pharmaceutical Drug: AYUNA

Last updated: July 29, 2025

Introduction

AYUNA is a pharmaceutical product gaining recognition within specialized therapeutic areas, notably dermatology and skincare. As with many niche pharmaceuticals, establishing a comprehensive supplier network is essential for ensuring quality, regulatory compliance, consistent drug availability, and cost efficiency. This article provides an in-depth overview of key suppliers involved in the manufacturing, sourcing, and distribution of AYUNA, highlighting the strategic considerations for stakeholders seeking reliable supply chains.

Overview of AYUNA’s Composition and Production

AYUNA’s active ingredients and formulation components dictate its supplier landscape. Commonly used ingredients in similar dermatological products include active pharmaceutical ingredients (APIs) such as anti-inflammatory agents, antioxidants, or bioactive compounds derived from natural or synthetic sources. The manufacturing process often involves specialized facilities adhering to Good Manufacturing Practices (GMP) to ensure drug safety and efficacy.

Primary Categories of Suppliers for AYUNA

1. Active Pharmaceutical Ingredient (API) Suppliers

The foundation of AYUNA’s efficacy hinges on high-quality APIs. Suppliers in this category are responsible for sourcing and manufacturing the key compounds.

• Global API Manufacturers:
  Major players such as Lonza, Siegfried, Alkermes, and Hikal supply APIs to pharmaceutical companies worldwide. Their extensive production capacities, rigorous quality controls, and compliance with international standards make them preferred options for custom or off-the-shelf APIs.

• Specialized Natural Extract Suppliers:
  For formulations that incorporate botanicals or bioactive plant extracts, suppliers like Indena, Naturex, and Givaudan provide high-quality natural ingredients. They often supply active ingredients with documented pharmaceutical-grade purity and stability.

• Innovative Synthesis Firms:
  Some formulations require bespoke or novel APIs, which necessitate working with custom synthesis providers such as Bachem or Carbogen Amcis, capable of producing complex molecules at scale.

2. Excipient Suppliers

Excipients play a critical role in formulation stability, bioavailability, and patient acceptability.

• Major Excipient Manufacturers:
  Companies like FMC (microcrystalline cellulose), DuPont (hydroxypropyl methylcellulose), and Ashland offer pharmaceutical-grade excipients complying with pharmacopeias.

• Natural and Biodegradable Additives:
  Increasing regulatory and consumer interest in natural formulations has boosted demand for suppliers of organic gellants, emulsifiers, and preservatives such as Herbstreith & Fox.

3. Packaging Material Suppliers

Ensuring product stability and safety requires reliable packaging suppliers.

• Tamper-evident Packaging Manufacturers:
  Sectors like Bormioli Pharma and Gerresheimer manufacture vials, ampoules, and secondary packaging compatible with dermatological and topical medications.

• Barrier Packaging Components:
  Suppliers providing air-tight, UV-protected packaging materials, often customized with allergen-free and eco-friendly options.

4. Contract Manufacturing Organizations (CMOs)

Many pharmaceutical companies outsource formulation and manufacturing to CMOs for scalability and cost-effectiveness.

• Leading CMOs:
  Catalent, Recipharm, and Recochem are prominent providers with facilities capable of producing topical dermatological formulations meeting GMP standards.

• Benefits of CMOs:
  Flexibility in production volumes, expertise in quality control, and streamlined regulatory compliance.

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Regulatory Considerations in Supplier Selection

Pharmaceutical suppliers must adhere to stringent regulatory standards:

• GMP compliance is mandatory for all suppliers supplying APIs, excipients, and primary packaging components.
• Suppliers should possess current FDA, EMA, or equivalent certifications and be subject to regular audits.
• Transparency in documentation, including Certificate of Analysis (CoA), Batch Records, and stability data, is essential.

Strategic Sourcing and Supply Chain Risk Management

Given the criticality of uninterrupted supply, companies should diversify their supplier base:

• Dual Sourcing: Engaging multiple suppliers for key ingredients mitigates risks related to geopolitical issues, supplier disruptions, or quality breaches.
• Supplier Qualification: Rigorous vetting processes—including audits, reference checks, and compliance assessments—ensure seamless integration into the supply chain.
• Geographical Considerations: Strategic sourcing from regions with robust regulatory frameworks (e.g., Europe, North America, Japan) enhances supply security.

Emerging Trends in AYUNA Supply Chain

• Sustainability Initiatives: Preference for suppliers committed to environmentally sustainable practices, eco-friendly packaging, and responsible sourcing.
• Technological Integration: Use of blockchain for transparency and traceability within the supply chain.
• Innovations in Natural Ingredients: Increased demand for plant-based, organic, and biodegradable components influences supplier choices.

Conclusion

The supplier landscape for AYUNA is characterized by specialized pharmaceutical-grade API manufacturers, excipient providers aligned with regulatory standards, reputable packaging firms, and experienced CMOs. Strategic selection, rigorous qualification, and diversification are imperative to ensure a stable supply chain that meets quality, safety, and regulatory requirements. As the pharmaceutical industry evolves, embracing sustainability and technological innovations in procurement will become increasingly vital for maintaining competitive advantage.

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Key Takeaways

• Reliable API suppliers include global manufacturers like Lonza and specialized firms offering natural extracts, vital for AYUNA’s formulation.
• Exipient sourcing must prioritize pharmaceutical-grade, compliant ingredients, with a growing emphasis on natural and biodegradable options.
• Packaging partners should provide tamper-evident, barrier-compatible solutions to ensure product integrity.
• Contract Manufacturing Organizations facilitate scalable, compliant production, minimizing risks related to supply disruptions.
• Diversification, rigorous qualification, and proactive supply chain management are essential to secure uninterrupted supply of AYUNA.

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FAQs

1. What are the main criteria for selecting suppliers for AYUNA?
Suppliers must demonstrate GMP compliance, provide comprehensive documentation (CoA, stability data), adhere to regulatory standards, and have a proven track record of quality assurance and reliable delivery.

2. Are natural ingredient suppliers suitable for pharmaceutical-grade AYUNA formulations?
Yes. Suppliers like Indena and Naturex specialize in natural, pharmaceutical-grade ingredients, provided they meet stringent purity, stability, and documentation standards.

3. How does geopolitical risk affect AYUNA’s supply chain?
Geopolitical disruptions can impact sourcing, especially from regions with political instability or trade restrictions. Diversification of suppliers across multiple regions mitigates these risks.

4. What role do Contract Manufacturing Organizations play in AYUNA’s supply chain?
CMOs are responsible for formulation, production, and packaging at scale, ensuring compliance with standards and facilitating flexible, cost-effective manufacturing.

5. How are sustainability trends influencing supplier choices?
Sustainability influences sourcing decisions, favoring suppliers committed to eco-friendly practices, biodegradable packaging, and responsible ingredient procurement.

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References

[1] European Medicines Agency. Good Manufacturing Practice (GMP).
[2] U.S. Food and Drug Administration. Guidance for Industry: Quality Systems Approach to Pharmaceutical Quality at Source.
[3] Lonza Group. API Manufacturing Capabilities and Certifications.
[4] Indena. Natural Extracts for Pharmaceutical Use.
[5] Bachem. Custom Synthesis Services for Pharmaceutical APIs.