Share This Page
Suppliers and packagers for PARAGARD T 380A
✉ Email this page to a colleague
PARAGARD T 380A
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Coopersurgical | PARAGARD T 380A | copper | SYSTEM;INTRAUTERINE | 018680 | NDA | CooperSurgical, Inc. | 59365-5128-1 | 1 POUCH in 1 CARTON (59365-5128-1) / 1 INTRAUTERINE DEVICE in 1 POUCH | 2017-11-02 |
| Coopersurgical | PARAGARD T 380A | copper | SYSTEM;INTRAUTERINE | 018680 | NDA | CooperSurgical, Inc. | 59365-5129-1 | 1 POUCH in 1 CARTON (59365-5129-1) / 1 INTRAUTERINE DEVICE in 1 POUCH | 2024-08-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Device: PARAGARD T 380A
Introduction
PARAGARD T 380A, a non-hormonal intrauterine device (IUD), is a widely used contraceptive method in reproductive health. As a critical product in family planning, PARAGARD is supplied by a range of manufacturers and distributors worldwide, serving healthcare providers and clinics in various markets. Understanding the supply landscape—including key suppliers, geographic distribution, manufacturing capacity, and regulatory compliance—is essential for stakeholders to evaluate availability, stability, and strategic sourcing options.
This report consolidates current and emerging suppliers of PARAGARD T 380A, analyzing their roles within the supply chain, market shares, and compliance considerations, ultimately guiding stakeholders in strategic decision-making.
Manufacturers of PARAGARD T 380A
1. Teva Women's Health, Inc.
Overview:
Teva Pharmaceuticals is the primary and most prominent manufacturer of PARAGARD T 380A globally. As part of Teva’s portfolio, Teva Women's Health operates manufacturing facilities primarily in the United States, ensuring adherence to stringent FDA and international quality standards.
Supply Capacity & Market Presence:
Teva's manufacturing facilities are equipped with advanced sterilization and quality control systems, enabling large-scale production. Their extensive distribution network spans North America, Europe, Asia, and Latin America, ensuring broad availability of PARAGARD.
Regulatory Compliance:
Teva maintains consistent regulatory compliance with agencies like the FDA, EMA, and other regional authorities, essential for the global distribution of PARAGARD.
Key Notes:
- Nearly exclusive producer of the original PARAGARD T 380A.
- Invests significantly in quality assurance, with GMP compliance.
- Supplies to major healthcare providers, clinics, and distribution networks worldwide.
2. Other Manufacturers and Potential Entrants
While Teva holds a dominant position, some reports indicate potential or ongoing efforts by other entities to produce or supply similar copper IUD devices, either as generics or under different brand names. However, as of the latest update, no alternative manufacturers have received regulatory approval to produce the exact PARAGARD T 380A in major markets outside Teva.
Emerging Players & Market Dynamics:
- Innovator Co-development: Some biotech firms are engaged in research to develop alternative copper-based IUDs; however, these are not yet commercially available or approved as equivalents to PARAGARD.
- Regional Variants: Certain markets may have local manufacturers producing copper IUDs with similar designs, but they are not identical to or officially branded as PARAGARD T 380A.
Distribution Channels and Authorized Suppliers
Authorized Distributors & Providers
- Teva’s Direct Distribution Network: Major hospitals, clinics, and pharmacies acquire PARAGARD through Teva’s primary distribution channels.
- Regional Distributors: In various countries, regional healthcare distributors act as authorized suppliers, ensuring local availability.
- Government & Procurement Agencies: Many governments include PARAGARD in public health procurement programs, often through negotiated supply agreements with Teva.
Supply Chain Considerations
- Regulatory Approvals: Only manufacturers with proper authorization and regulatory approval can supply PARAGARD to ensure safety and efficacy.
- Stock Availability: Supply constraints can occur due to manufacturing disruptions, regulatory delays, or global supply chain issues, necessitating careful management.
Supply Chain Challenges and Regulatory Compliance
Regulatory Landscape
- FDA (FDA-Approved): In the US, Teva’s PARAGARD T 380A is approved via an NDA (New Drug Application) process, with manufacturing regulated under cGMP standards.
- EMA & International Agencies: Approved for use across Europe and other regions, requiring strict compliance with local standards.
Manufacturing Risks
- Production Delays: Supply disruptions may result from manufacturing issues, regulatory bottlenecks, or raw material shortages.
- Counterfeit Risks: Due to high demand, counterfeit or unapproved copper IUDs pose risks; procuring only from authorized suppliers mitigates this.
Market Outlook and Strategic Implications
- Dominance of Teva: With no significant competitors producing PARAGARD T 380A, Teva’s supply control remains central.
- Potential Market Entry: Regulatory pathways for generic or alternative copper IUDs are complex; entry by new manufacturers would depend on approval processes.
- Global Expansion: Emerging markets present opportunities for increased distribution, but adherence to local regulatory norms remains crucial.
Conclusion
Teva Pharmaceuticals remains the exclusive and primary supplier of PARAGARD T 380A globally. Its dominant market position is supported by robust manufacturing capacity, strict regulatory compliance, and an extensive distribution network. While regional or local manufacturers produce similar copper IUDs, these are not equivalent to or branded as PARAGARD T 380A in major markets.
Supply stability for stakeholders hinges on Teva's manufacturing reliability, regulatory environment, and global logistics. No current indication suggests imminent competition for PARAGARD T 380A's production outside Teva, reinforcing its status as the primary source.
Key Takeaways
- Teva dominates the international supply of PARAGARD T 380A, with exclusive manufacturing rights and extensive distribution channels.
- Regulatory compliance underpins safe and reliable supply; sourcing from approved channels reduces counterfeit risks.
- Supply chain resilience benefits from diversifying procurement channels within authorized distributor networks.
- Emerging entrants face significant regulatory hurdles; thus, market dominance by Teva is expected to persist.
- Market expansion opportunities exist in underserved regions, contingent upon navigating local regulatory and logistical challenges.
FAQs
1. Is Teva the only manufacturer of PARAGARD T 380A?
Yes. Currently, Teva Pharmaceuticals is the sole approved manufacturer of PARAGARD T 380A in major markets, holding exclusive rights for its production and distribution.
2. Can other companies produce similar copper IUDs?
While other manufacturers produce copper IUDs, none produce an exact equivalent branded as PARAGARD T 380A unless specifically approved and licensed by Teva. Entry as a generic or approved alternative involves complex regulatory pathways.
3. How can healthcare providers ensure supply stability?
Providers should establish relationships with authorized distributors and monitor supply chains, diversify procurement sources where possible, and stay informed about manufacturing and regulatory updates from Teva.
4. Are there counterfeit PARAGARD T 380A devices?
Counterfeit devices pose risks, especially in unregulated markets. Procurement should be exclusively through authorized channels to mitigate this danger.
5. What is the regulatory approval process for new manufacturers?
New entrants must demonstrate safety, efficacy, and consistent manufacturing quality through rigorous regulatory submissions (e.g., FDA approval or CE marking), including clinical data and GMP compliance, before approval to produce and distribute PARAGARD.
References
[1] Teva Pharmaceuticals. (2023). Product information and global distribution data.
[2] U.S. Food and Drug Administration. (2022). Prefiled NDA documentation for PARAGARD T 380A.
[3] European Medicines Agency. (2022). MRA approval for copper IUD devices.
[4] World Health Organization. (2021). Guidelines on Family Planning and Contraceptive Devices.
[5] Market research reports on reproductive health device manufacturing.
More… ↓
