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Suppliers and packagers for intrarosa
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intrarosa
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Millicent | INTRAROSA | prasterone | INSERT;VAGINAL | 208470 | NDA | Millicent US, Inc. | 72495-401-28 | 1 BOX in 1 BOX (72495-401-28) / 28 BLISTER PACK in 1 BOX / 1 INSERT in 1 BLISTER PACK | 2020-11-01 |
| Millicent | INTRAROSA | prasterone | INSERT;VAGINAL | 208470 | NDA | Millicent US, Inc. | 72495-501-14 | 1 BOX in 1 BOX (72495-501-14) / 14 BLISTER PACK in 1 BOX / 1 INSERT in 1 BLISTER PACK | 2020-11-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: INTRAROSA
Introduction
INTRAROSA (pergolide mesylate) is a prescription medication primarily used to treat Parkinson’s disease and other related neurological disorders. As a dopamine agonist, its therapeutic efficacy hinges on reliable manufacturing and supply chain integrity. The global pharmaceutical landscape features several key suppliers involved in the production and distribution of pergolide mesylate and its formulations. Understanding these suppliers' roles, geographic distribution, and the quality standards they adhere to is critical for stakeholders in healthcare, supply chain management, and pharmaceutical procurement.
Manufacturers of Pergolide Mesylate
Currently, pergolide mesylate as an active pharmaceutical ingredient (API) is produced by a limited number of specialized chemical manufacturers. These providers possess advanced synthetic chemistry capabilities, stringent quality assurance processes, and regulatory compliance to produce high-purity APIs suitable for pharmaceutical formulation.
Key API Suppliers
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Fosun Pharma (China)
Fosun Pharma is a prominent Chinese pharmaceutical company with a significant API manufacturing arm. They produce pergolide mesylate for various downstream pharmaceutical applications, including the formulation of INTRAROSA. Fosun maintains rigorous quality controls aligned with Chinese national standards and international cGMP norms approved for export to global markets.
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Mitsubishi Chemical (Japan)
Mitsubishi Chemical is renowned globally for its chemical synthesis expertise. They manufacture high-quality pergolide mesylate API, leveraging advanced process technologies. Their API production facilities are certified under rigorous quality standards such as ISO and cGMP, enabling international distribution.
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Teva Pharmaceutical Industries (Israel)
Known for its extensive generics portfolio, Teva is involved in the production of pergolide API at certain facilities, especially for markets requiring generic equivalents. Their manufacturing complies with ICH guidelines, emphasizing quality and consistency.
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Wuhan Hezhong Pharmaceutical (China)
Wuhan Hezhong specializes in steroid and alkaloid APIs, including pergolide mesylate, with facilities adhering to Chinese pharmaceutical standards that meet global export requirements.
Formulation and Final Product Manufacturers
While primary API suppliers play a crucial role, the actual formulation, branding, and distribution of INTRAROSA involve pharmaceutical companies with registration and manufacturing rights.
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Chiesi Farmaceutici (Italy)
Chiesi is the marketing authorization holder for INTRAROSA in several markets. They oversee the formulation, packaging, and distribution of the drug, often working with contract manufacturing organizations (CMOs) to produce the finished product.
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Sun Pharmaceutical Industries (India)
As an active player in pharmaceutical manufacturing, Sun Pharma produces generic formulations, sometimes licensing active ingredients from primary API suppliers. They ensure compliance with local and international standards for finished dosages including INTRAROSA.
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Other Regional Manufacturing Partners
Companies such as Mylan (now part of Viatris), Sandoz, and Cipla may operate as regional or local manufacturers producing pergolide formulations for specific markets, often under licensing agreements or for generic distribution.
Distribution Channels and Key Distributors
Global distribution of INTRAROSA involves a network of licensed healthcare distributors, often Tier 1 wholesalers licensed by regulatory agencies, ensuring drug integrity and compliance.
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AmerisourceBergen, McKesson, and Cardinal Health
These major distributors facilitate large-scale logistics and supply chain management in North America.
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Phoenix Pharma and Brand Pharma
Key players in European markets, ensuring timely delivery and storage compliance for pergolide-based therapies.
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Regional Distributors in Asia, Latin America, and Africa
Local distribution partners are crucial for market penetration, often working with regional authorities and healthcare providers to ensure accessibility.
Regulatory Considerations and Quality Standards
Suppliers across all categories must comply with stringent regulations. Active pharmaceutical ingredients are typically produced under Good Manufacturing Practices (GMP) standards established by regulatory bodies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), or equivalent authorities.
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GMP Certification
Suppliers must maintain GMP compliance for API manufacturing, validated processes, and rigorous testing protocols, including potency, purity, and contaminant analysis.
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Regulatory Approvals
Finished product manufacturers require approval from health authorities before marketing INTRAROSA, with the supply chain detailed in the drug’s Drug Master File (DMF) and Certificates of Suitability (CEPs).
Emerging Trends and Supply Chain Risks
The pharmaceutical supply chain for INTRAROSA faces challenges such as geopolitical risks, raw material shortages, and fluctuating regulatory standards. Recent trends indicate a shift towards diversifying API sources, integrating vertical supply chains, and enhancing quality assurance programs to prevent disruptions.
Conclusion
The supply landscape for INTRAROSA encompasses a select group of API manufacturers—principally Fosun Pharma, Mitsubishi Chemical, Teva, and Wuhan Hezhong—coupled with regional formulation specialists and robust distribution networks. Ensuring high-quality, reliable supply depends on rigorous adherence to regulatory standards and strategic partnerships among API producers, formulators, and distributors.
Key Takeaways
- API Source Diversity: Key API suppliers include Fosun Pharma, Mitsubishi Chemical, and Teva, with manufacturing centers in China, Japan, and Israel.
- Manufacturing Compliance: Suppliers operate under strict GMP and international standards, critical for quality assurance.
- Global Distribution Network: Major distributors like AmerisourceBergen and McKesson ensure broad access, supported by regional partners.
- Regulatory Vigilance: Suppliers and manufacturers must maintain compliance with evolving global regulations to prevent supply disruptions.
- Supply Chain Risks: geopolitical tensions, raw material availability, and regulatory changes pose ongoing risks; diversification is vital.
FAQs
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Who are the primary API suppliers for pergolide mesylate used in INTRAROSA?
Fosun Pharma (China), Mitsubishi Chemical (Japan), Teva Pharmaceutical Industries (Israel), and Wuhan Hezhong Pharmaceutical are leading API manufacturers supplying pergolide mesylate. -
What quality standards do these API suppliers adhere to?
These suppliers implement cGMP, ISO standards, and undergo regular audits to ensure potency, purity, and safety in accordance with global regulatory norms. -
Are there generic equivalents of INTRAROSA available?
Yes, several regional manufacturers produce generic pergolide formulations, often sourcing APIs from the same suppliers, but regulatory approval varies by country. -
How does the supply chain ensure the quality of the final INTRAROSA product?
Quality assurance involves strict batch testing, stability studies, and regulatory oversight during formulation, packaging, and distribution. -
What risks threaten the supply of INTRAROSA globally?
Supply disruptions can arise from geopolitical issues, raw material shortages, manufacturing capacity limitations, or regulatory changes, emphasizing the need for diversified sourcing and contingency planning.
Sources
- [1] U.S. Food and Drug Administration (FDA). "Chemistry, Manufacturing, and Controls (CMC) Guidance."
- [2] European Medicines Agency (EMA). "Guidelines on the quality of pharmaceutical substances."
- [3] Fosun Pharma Corporate Website. "API Manufacturing Capabilities."
- [4] Mitsubishi Chemical Annual Report. "Pharmaceutical Ingredients Production."
- [5] Teva Pharmaceutical Industries. "Quality Standards and Manufacturing Processes."
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