Suppliers and packagers for AUROVELA FE 1.5/30

AUROVELA FE 1.5/30

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	AUROVELA FE 1.5/30	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	207580	ANDA	Aurobindo Pharma Limited	65862-941-58	5 POUCH in 1 CARTON (65862-941-58) / 1 BLISTER PACK in 1 POUCH (65862-941-87) / 1 KIT in 1 BLISTER PACK	2017-06-15
Aurobindo Pharma	AUROVELA FE 1.5/30	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	207580	ANDA	Aurobindo Pharma Limited	65862-941-88	3 POUCH in 1 CARTON (65862-941-88) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK	2017-06-15

Suppliers for the Pharmaceutical Drug: AUROVELA FE 1.5/30

Last updated: August 9, 2025

Introduction

Healthcare providers, pharmaceutical distributors, and regulatory bodies across the globe seek comprehensive information about the supply chain and sourcing of medications such as AUROVELA FE 1.5/30. This oral contraceptive combines drospirenone and ethinylestradiol, used primarily for contraception and management of hormonal disorders. Given its widespread use and clinical significance, identifying reliable suppliers and understanding the licensing landscape is crucial for stakeholders aiming to ensure product availability and compliance.

This article explores the key suppliers of AUROVELA FE 1.5/30, detailing the manufacturing landscape, licensing arrangements, and market dynamics shaping its distribution. The focus is on providing authoritative insights to help professionals and organizations optimize procurement strategies and regulatory compliance.

Manufacturers and Licensing Overview

AUROVELA FE 1.5/30 is marketed globally under various brand names, often associated with licensed manufacturers. The primary active pharmaceutical ingredient (API) suppliers include established chemical firms with capacity to produce drospirenone and ethinylestradiol at pharmaceutical standards.

1. Original Manufacturer and Licensed Producers

While the original brand, Aurovela Fe 1.5/30, is associated with Aurobindo Pharma, a leading Indian pharmaceutical company, the product's manufacturing rights are often licensed to other reputable firms through regional and global licensing agreements. This decentralization allows several manufacturers to produce AUROVELA FE 1.5/30 under authorized licenses, ensuring broader market access.

2. Contract Manufacturing Organizations (CMOs)

Many pharmaceutical companies partner with CMOs to manufacture AUROVELA FE 1.5/30, especially to overcome capacity constraints or meet specific regional regulatory requirements. These CMOs typically possess robust Good Manufacturing Practice (GMP) certifications and work under strict confidentiality agreements to maintain product integrity.

3. Active Pharmaceutical Ingredient (API) Suppliers

Secure supply of high-quality APIs is fundamental. Major API suppliers include:

• Hetero Labs: A prominent Indian API manufacturer known for producing drospirenone and ethinylestradiol.
• Aurobindo Pharma: Besides manufacturing finished dosage forms, Aurobindo produces APIs for regional and global markets.
• Mylan (now part of Viatris): Supplies APIs through strategic partnerships and direct manufacturing.
• Sun Pharmaceutical Industries: A key player in API supply, focusing on hormonal compounds.

The APIs sourced from these firms undergo rigorous quality control standards to comply with international regulatory norms.

Regional Suppliers and Market-Specific Licensing

In segments where the original manufacturer does not hold direct licensing rights, regional pharmaceutical companies often act as licensed producers. For instance, in Latin America, South-East Asia, and Africa, local firms may manufacture AUROVELA FE 1.5/30 under license from the original patent holders or through established patent license agreements.

Regional Licensing Agreements

Often, licensing agreements are negotiated to permit local manufacturing to reduce costs, improve supply chain efficiency, and meet regional regulatory requirements. Companies such as Pfizer, Bayer, or local generic manufacturers may hold manufacturing or distribution licenses depending on regional patent laws and regulatory frameworks.

Generic Manufacturers

Certain generic companies produce bioequivalent formulations of AUROVELA FE 1.5/30 post-patent expiry or under license agreements. Notable examples include:

• Gedeon Richter (Europe)
• Mankind Pharma (India)
• Cipla (India)

These firms source APIs from authorized suppliers and adhere to stringent quality standards, making their products suitable for market entry and regulatory approval.

Distribution Channels and Market Variability

Distribution of AUROVELA FE 1.5/30 involves multiple tiers:

• Authorized Distributors: Licensed pharmaceutical wholesalers distributing products to hospitals, clinics, and pharmacies.
• Regulatory Approvals: Each manufacturing site must obtain permits from regulatory bodies such as the FDA (U.S.), EMA (Europe), or CDSCO (India), affirming GMP compliance.
• Supply Chain Integrity: Ensuring tamper-evident packaging, serialization, and traceability is essential, especially given the importance of authentication in hormonal drugs.

Market Dynamics

The supply landscape varies by region, often influenced by patent laws, market demand, and regional regulations:

• In North America and Europe, AUROVELA FE 1.5/30 formulations are likely produced under license through multinational pharmaceutical companies.
• In Asian markets, Indian and Chinese firms dominate, utilizing APIs from local or international suppliers.
• In emerging markets, local generics manufacturers frequently produce AUROVELA FE 1.5/30 under licensing agreements or through authorized APIs.

Regulatory and Patent Considerations

Patent exclusivity significantly influences suppliers’ licensing options. Many formulations’ patents expired in key markets like the U.S. and Europe, fostering generic manufacturing and increased supplier diversity. However, some regional patents or regulatory exclusivities may limit the availability of licensed suppliers, prompting reliance on imported APIs or regional manufacturing.

Stakeholders must verify the licensing status via:

• Regulatory filings
• Patent databases (e.g., Patentscope, Espacenet)
• Manufacturer disclosures

Ensuring all suppliers are compliant with regional regulations minimizes supply chain risks and legal liabilities.

Key Suppliers Summary

Supplier Type	Notable Entities	Region	Notes
Original Manufacturer	Aurobindo Pharma	India	Licensed producer, API and finished dosage forms
API Suppliers	Hetero Labs, Mylan, Sun Pharma	India	API sourcing and manufacturing
Licensed Regional Producers	Mankind Pharma, Cipla	India	Generic formulations under license
Contract Manufacturers	Multiple CMOs globally	Global	Packaging, formulation, and distribution
Regional License Holders	Bayer, Pfizer	Europe, North America	Licenses post-patent expiry

Conclusion

The supply chain for AUROVELA FE 1.5/30 involves a complex network of licensed manufacturers, API suppliers, and regional distributors. Indian pharmaceutical companies such as Aurobindo Pharma, Hetero Labs, Cipla, and Sun Pharma are key players in providing high-quality APIs and finished formulations. Licensing agreements govern market access, with regional manufacturers and generic firms expanding availability, especially in emerging markets.

Understanding these dynamics enables healthcare providers, distributors, and regulatory agencies to optimize procurement, ensure product integrity, and maintain supply chain resilience.

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Key Takeaways

• Diverse Supplier Base: Indian pharmaceutical companies dominate the API production and formulation of AUROVELA FE 1.5/30, supported by regional licensing and generic manufacturing.
• Licensing Landscape: Licensing agreements are pivotal, especially in regions where patent protections have expired, fostering generic competition.
• Regulatory Compliance: Suppliers must adhere to GMP standards and obtain necessary regulatory approvals to ensure product quality and safety.
• Supply Chain Strategies: Engaging with licensed manufacturers and verified API suppliers reduces risks of counterfeit products and supply disruptions.
• Future Outlook: Patent expirations and evolving licensing arrangements are likely to expand supplier options, emphasizing the importance of ongoing regulatory and market intelligence.

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FAQs

1. Who are the main licensed manufacturers of AUROVELA FE 1.5/30?
Major licensed manufacturers include Aurobindo Pharma, along with regional generic firms like Cipla and Mankind Pharma in India. Their licensing agreements and market-specific licenses facilitate local production and distribution.

2. How can one verify the authenticity of AUROVELA FE 1.5/30 supplies?
Verification involves checking for official regulatory approval numbers, serialization on packaging, and sourcing from authorized distributors. Trademark registration and certification documents serve as additional verification tools.

3. Are there regional differences in the suppliers of AUROVELA FE 1.5/30?
Yes, licensing rights and manufacturing capabilities vary by region, influencing supplier options. Indian companies dominate API supply, while regional manufacturers in Latin America and Africa may produce under local licenses.

4. How does patent status affect the supplier landscape for AUROVELA FE 1.5/30?
Patent expirations enable generic manufacturing and increase the number of qualified suppliers. Until patents expire, manufacturing rights are restricted to patent holders or licensees authorized by patent owners.

5. What risks are associated with sourcing AUROVELA FE 1.5/30 from multiple suppliers?
Risks include variability in product quality, supply disruptions, counterfeit products, and regulatory non-compliance. Establishing supplier qualification programs and ongoing audits mitigates these risks.

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Sources
[1] Aurobindo Pharma. Company Website. (2023)
[2] Indian Pharmacopoeia Commission. API Standards. (2023)
[3] PatentScope. Patent Data and Licensing Information. (2023)
[4] European Medicines Agency. Regulatory Approvals. (2023)
[5] U.S. Food and Drug Administration. Approved Drugs Database. (2023)