Suppliers and packagers for solosec

solosec

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Evofem Inc	SOLOSEC	secnidazole	GRANULE;ORAL	209363	NDA	Evofem Inc.	69751-400-01	1 PACKET in 1 CARTON (69751-400-01) / 2 g in 1 PACKET	2018-05-31

Suppliers for the Pharmaceutical Drug: Solosec

Last updated: July 31, 2025

Introduction

Solosec (secnidazole) is an oral antibiotic primarily prescribed to treat bacterial vaginosis (BV), trichomoniasis, and other anaerobic bacterial infections. Approved by the U.S. Food and Drug Administration (FDA) in 2017, Solosec has gained prominence for its targeted formulation and simplified dosing regimen. As a relatively new entrant in the antimicrobial market, understanding its supplier landscape is pivotal for stakeholders involved in procurement, distribution, and strategic planning within the pharmaceutical supply chain.

Manufacturing Background and Patent Overview

Solosec is developed and marketed by Symbiomix Therapeutics, a subsidiary of Lupin Limited, an Indian multinational pharmaceutical company. Lupin acquired Symbiomix in 2018, enhancing its portfolio in women's health. The active pharmaceutical ingredient (API), secnidazole, is synthesized through specialized processes, and the formulation involves proprietary encapsulation to facilitate single-dose administration.

The patent protection for Solosec, including its formulation and methods of use, was granted to safeguard market exclusivity during critical commercialization years. Patent expiry timelines influence the entry of generic manufacturers, which profoundly impacts supply dynamics.

Key Suppliers of Active Pharmaceutical Ingredient (API)

The supply chain for Solosec hinges on its API, secnidazole. As a niche antimicrobial, secnidazole’s production is concentrated among select manufacturers, primarily in regions with established cheminformatics capabilities, notably India and China.

Primary API Suppliers

1. Lupin Limited (India)

   • Role: As the developer and exclusive marketer of Solosec, Lupin is inherently involved in the sourcing of secnidazole API. The company has internal facilities for API manufacturing, approved under rigorous regulatory standards (e.g., FDA, EMA).
   • Supply Status: Lupin’s integrated supply chain ensures consistent API availability, especially as it holds patents protecting Solosec’s formulation.

2. Dr. Reddy’s Laboratories (India)

   • Role: A prominent generic API manufacturer, Dr. Reddy’s produces secnidazole for various markets. Its facilities are GMP-certified, and the company supplies APIs to multiple formulators globally.
   • Supply Status: Widely recognized for high-quality APIs, Dr. Reddy’s likely supplies secnidazole to secondary manufacturers and generic drug producers. However, for Solosec-specific formulations, Lupin’s internal API sources dominate.

3. Changzhou Sati Pharmaceutical Co., Ltd. (China)

   • Role: A notable API manufacturer in China specializing in nitroimidazole derivatives, including secnidazole.
   • Supply Status: Sati Pharmaceutical exports API worldwide and may serve as an alternative source if domestic or regional supply chains are disrupted.

4. Other Contract Manufacturing Organizations (CMOs)

   • Several CMOs in India and China are capable of producing secnidazole under contract for larger pharmaceutical firms, providing flexibility in supply chain management.

Formulation and Packaging Suppliers

While API supply forms the backbone of Solosec’s availability, the finished drug’s manufacturing—including encapsulation, packaging, and distribution—is handled primarily by Lupin. The proprietary packaging, designed for single-dose convenience, involves specialized capsule manufacturing processes carried out in GMP-certified facilities.

Distribution and Supply Chain Dynamics

Lupin’s integrated supply chain ensures regulatory compliance and quality control. The supply chain for Solosec extends to global markets via established distribution agreements. However, external factors such as raw material shortages, geopolitical tensions, or regulatory changes can impact availability.

Impact of Patent Status and Generics

The patent protection for Solosec provides market exclusivity until approximately 2024–2025, depending on jurisdiction-specific patent expiry. This exclusivity limits generic competition, highly centralized manufacturing, and supply. Post-patent expiry could lead to multiple generic manufacturers entering the market, dramatically altering the supply chain landscape and increasing the number of suppliers for both API and finished product.

Supply Chain Challenges and Considerations

• Raw Material Availability: Secnidazole synthesis requires specific intermediates susceptible to supply constraints, especially during global disruptions.
• Regulatory Compliance: Ensuring GMP standards across API suppliers minimizes risks of quality issues impacting supply continuity.
• Intellectual Property: Patent protections restrict generic manufacturing prior to expiry, primarily affecting market competition rather than API supply.

Future Outlook and Emerging Suppliers

Post-patent expiration, expect an influx of generic manufacturers from India, China, and other regions. Existing API suppliers are likely to expand capacity, and new entrants may emerge leveraging cost advantages.

Lupin’s strategic positioning involves securing multiple API suppliers and refining logistics to prevent shortages, especially given Solosec’s targeted indication and clinical demand.

Key Takeaways

• Lupin Limited is the primary supplier of API and finished formulations for Solosec.
• Several established Indian and Chinese pharmaceutical manufacturers produce secnidazole, contributing to a diversified supply chain.
• Patent protections currently restrict generic competition, consolidating supply under Lupin until patent expiry.
• Post-2025, expect increased competition and multiple API suppliers, potentially stabilizing or reducing prices.
• Supply chain resilience depends on securing high-quality APIs, maintaining regulatory compliance, and strategic inventory management.

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FAQs

1. Who are the main API suppliers for Solosec?
Lupin Limited is the primary API supplier as part of its integrated manufacturing process. Other notable producers include Dr. Reddy’s Laboratories and Chinese companies like Changzhou Sati Pharmaceutical, which supply secnidazole to the broader market.

2. When will generic versions of Solosec likely enter the market?
Generic competition is expected after the expiration of key patents, anticipated around 2024–2025, leading to increased manufacturing entry from various suppliers.

3. How does patent protection impact the supply chain for Solosec?
Patent protections restrict generic manufacturing, concentrating supply under Lupin and limiting the number of API and finished product suppliers during the patent life.

4. What risks could disrupt Solosec’s supply?
Potential risks include raw material shortages, manufacturing disruptions, geopolitical issues, and regulatory non-compliance among API suppliers.

5. Are there alternative sources for Secnidazole outside Lupin’s supply chain?
Yes, multiple API manufacturers across India and China produce secnidazole, but clinical use and brand-specific formulations like Solosec are controlled by Lupin. Post-patent expiry, these sources could supply generic formulations.

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References

[1] FDA Approval of Solosec (secnidazole) for Bacterial Vaginosis: U.S. Food and Drug Administration.
[2] Lupin Limited Annual Report: Strategic overview of manufacturing capacity and supplier relationships.
[3] Global API Market Reports: Production capacities and key players in nitroimidazole derivatives.
[4] Patent tracking databases: Patent expiry timelines for Solosec formulations.