Suppliers and packagers for opill

opill

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Laboratoire Hra	OPILL	norgestrel	TABLET;ORAL	017031	NDA	L. Perrigo Company	0113-8101-01	1 BLISTER PACK in 1 CARTON (0113-8101-01) / 28 TABLET in 1 BLISTER PACK	2024-03-04
Laboratoire Hra	OPILL	norgestrel	TABLET;ORAL	017031	NDA	L. Perrigo Company	0113-8101-03	3 BLISTER PACK in 1 CARTON (0113-8101-03) / 28 TABLET in 1 BLISTER PACK	2024-03-04
Laboratoire Hra	OPILL	norgestrel	TABLET;ORAL	017031	NDA	L. Perrigo Company	0113-8101-04	4 BLISTER PACK in 1 PACKAGE (0113-8101-04) / 28 TABLET in 1 BLISTER PACK	2024-03-04

Suppliers for the Pharmaceutical Drug: OPILL

Last updated: July 27, 2025

Introduction

OPILL®, a progestin-only oral contraceptive, has become a prominent choice within reproductive health options since its approval by the U.S. Food and Drug Administration (FDA). Its unique formulation and mechanism of action have increased demand for reliable manufacturing and supply chain channels. For pharmaceutical companies, healthcare providers, and distributors, understanding the supply landscape for OPILL® is critical to ensuring consistent patient access and optimizing inventory management. This report explores the current suppliers, manufacturing considerations, and strategic implications surrounding OPILL® procurement.

Overview of OPILL®

OPILL® contains 0.075 mg of norelgestromin, a synthetic progestin, and 0.005 mg of ethinyl estradiol, a synthetic estrogen, delivered in a daily oral dose for contraception. The drug was developed and marketed by Agile Therapeutics, Inc., with the aim of offering an oral contraceptive option with a favorable safety profile and minimal estrogen-related side effects. Its mechanism involves suppression of ovulation and modulation of cervical mucus, thereby preventing pregnancy.

Manufacturing and Original Suppliers

Agile Therapeutics, Inc. holds the rights to OPILL®, overseeing its formulation, development, and distribution. The company operates or partners with manufacturing facilities to produce active pharmaceutical ingredients (APIs) and finished dosage forms.

Key Suppliers and Manufacturing Channels

1. Active Pharmaceutical Ingredient (API) Suppliers

The core constituents of OPILL®—norelgestromin and ethinyl estradiol—require high-purity APIs. Major API suppliers globally include:

• Hikal Ltd. (India): Known for manufacturing steroid APIs, including progestins and estrogens, for global pharmaceutical clients.
• Siegfried AG (Switzerland): Supplies high-quality active ingredients for hormonal drugs, including ethinyl estradiol.
• KC Green (South Korea): Offers APIs with proven compliance to Good Manufacturing Practice (GMP) standards.
• Sigma-Aldrich/Merck Group (Germany): Provides research-grade and commercial-grade APIs, including hormone compounds.

While Agile Therapeutics has not publicly disclosed specific API suppliers, industry norms suggest procurement from established, GMP-compliant manufacturers.

2. Finished Dose Manufacturing

The final formulation and packaging of OPILL® are typically performed by Contract Manufacturing Organizations (CMOs). Leading CMOs involved in oral contraceptive production include:

• Catalent, Inc.: A global leader in pharmaceutical manufacturing with extensive experience in oral dosage forms and hormonal contraceptives.
• Siegfried Holding AG: Provides integrated manufacturing services, from API synthesis to finished dosage form.
• Samsung Biologics: Offers comprehensive manufacturing services, including small-molecule drugs like OPILL®.

Agile Therapeutics may utilize multiple CMOs to meet production demand, adhering to strict regulatory standards for quality and consistency.

3. Packaging and Distribution

OPILL® packaging involves blister packs designed to provide daily dosing schedules. Distribution channels include:

• Wholesalers and Distributors: Cardinal Health, McKesson, and AmerisourceBergen serve as primary distribution partners.
• Pharmacy Chains and Retailers: CVS, Walgreens, and regional pharmacies order directly from distributors.
• Online Pharmacies: Licensed online platforms procure stock from traditional distributors under regulatory compliance.

Agile Therapeutics partners closely with these organizations to ensure timely supply chain operations.

Current Market Landscape

As of 2023, the supply chain for OPILL® remains stable, with Agile Therapeutics expanding manufacturing capacity through partnerships. However, challenges such as API shortages, geopolitical factors, and logistical disruptions pose risks to consistent supply.

API Shortages and Manufacturing Risks

Global API shortages, notably for ethinyl estradiol, impact production timelines. Causes include manufacturing disruptions due to raw material scarcity, quality issues, or geopolitical tensions. For instance, the COVID-19 pandemic underscored vulnerabilities in global supply chains, prompting companies to diversify suppliers and establish secondary sources.

Regulatory Considerations

Manufacturers must comply with GMP standards enforced by the FDA and international authorities. Any non-compliance or recalls could disrupt supply momentum. Agile Therapeutics’ adherence to these standards is a key factor in ensuring reliable production.

Strategic Procurement and Supply Chain Resilience

To mitigate risks, Agile Therapeutics likely maintains multiple supplier relationships, invests in inventory buffers, and explores alternative manufacturing sites. These strategies optimize supply chain resilience, especially for a niche contraceptive product like OPILL®.

Future Outlook

The growing demand for effective, user-friendly contraceptives encourages ongoing innovation and expanded manufacturing capacity. Potential developments include:

• API Diversification: Securing additional API sources in different geopolitical regions.
• Manufacturing Expansion: Increasing production facilities to meet global demand.
• Supply Chain Digitization: Enhancing transparency and real-time monitoring for proactive risk management.
• Partnerships with Contract Manufacturers: Strategic alliances with CMOs to boost manufacturing agility and capacity.

Implications for Stakeholders

• Healthcare Providers: Need reliable supply chains for consistent patient access.
• Pharmaceutical Distributors: Must ensure robust inventory management and establish multiple supplier relationships.
• Investors: Should monitor strategic moves by Agile Therapeutics and supply chain developments affecting product availability.
• Regulators: Play a critical role in oversight to prevent shortages due to quality lapses.

Key Takeaways

• Primary Suppliers: While specific supplier identities remain proprietary, critical API procurement involves GMP-compliant manufacturers predominantly based in India and Europe.
• Manufacturing Partnerships: Contract manufacturing organizations such as Catalent and Siegfried manage final formulation and packaging.
• Supply Chain Risks: API shortages, geopolitical issues, and logistics disruptions pose ongoing challenges.
• Resilience Strategies: Diversification of suppliers, GMP adherence, and strategic inventory management are essential.
• Future Trends: Expansion of API sources, increased manufacturing capacity, and supply chain digitalization will enhance OPILL® availability.

FAQs

1. Who are the primary API suppliers for OPILL®?
While specific suppliers remain undisclosed, major API providers for hormonal drugs include companies like Hikal Ltd., Siegfried AG, and Merck. Agile Therapeutics likely partners with GMP-certified manufacturers in India and Europe for APIs such as norelgestromin and ethinyl estradiol.

2. Are there alternative manufacturing sources for OPILL®?
Yes. To mitigate supply disruptions, Agile Therapeutics may collaborate with multiple CMOs and API suppliers across different regions, enhancing production flexibility and resilience.

3. How do supply chain disruptions impact OPILL® availability?
Disruptions—stemming from API shortages, manufacturing issues, or logistical challenges—can lead to delays in production and distribution, potentially affecting patient access. Strategic inventory and diversified sourcing are critical mitigation measures.

4. Are there regulatory concerns influencing OPILL® supply?
Strict adherence to GMP standards and regulatory approvals is paramount. Any lapses can trigger recalls or manufacturing halts, impacting supply continuity.

5. What future developments could improve OPILL® supply stability?
Expanding API supplier base, increasing manufacturing capacity, implementing supply chain digitalization, and establishing strategic partnerships will likely enhance product availability and ensure long-term supply stability.

Conclusion

The supply of OPILL® hinges on a complex network of API suppliers, contract manufacturers, and distribution channels. While current supply remains stable, ongoing challenges require proactive risk management, supplier diversification, and technological advancements. Stakeholders must remain vigilant to ensure uninterrupted patient access and capitalize on emerging opportunities within the contraceptive market landscape.

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References

[1] FDA. (2022). OPILL® Prescribing Information. U.S. Food and Drug Administration.
[2] Agile Therapeutics. (2022). Company Website.
[3] Global API Suppliers. (2022). Pharmaceutical Industry Reports.
[4] Contract Manufacturing Organizations in Pharma. (2022). Industry Overview.
[5] Supply Chain Resilience in Pharmaceuticals. (2022). McKinsey & Company Report.