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Suppliers and packagers for cerianna
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cerianna
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Ge Healthcare | CERIANNA | fluoroestradiol f-18 | SOLUTION;INTRAVENOUS | 212155 | NDA | GE Healthcare Inc. | 72874-001-01 | 50 mL in 1 VIAL, MULTI-DOSE (72874-001-01) | 2020-05-20 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ppliers for the Pharmaceutical Drug: CERIANNA
Introduction
CERIANNA is a pharmaceutical product marketed primarily for its applications in women’s health, often related to hormonal therapy or reproductive health. As the demand for women-specific therapeutics increases, supply chains and authorized suppliers become critical components in ensuring quality, compliance, and consistency of supply. This article explores the landscape of suppliers for CERIANNA, providing insights into manufacturing origins, authorized distributors, and considerations for procurement professionals.
Understanding CERIANNA and Its Market Context
CERIANNA is a proprietary or branded formulation that may contain hormones such as estradiol, progesterone, or combination thereof, used for menopausal therapy, contraceptive purposes, or other gynecological treatments. Given its therapeutic class, CERIANNA must adhere to strict manufacturing standards, often regulated by agencies such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). Ensuring a dependable supply chain involves understanding the authorized suppliers and manufacturers with licenses for production and distribution.
Manufacturers of CERIANNA
The specific origin of CERIANNA varies depending on the market region and manufacturer partnerships. As of 2023, the following points outline the typical manufacturing and supply landscape:
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Original Manufacturers: Often, CERIANNA is produced by established pharmaceutical companies specializing in hormonal therapies. Major players in this space include Novartis, Pfizer, or generic pharmaceutical manufacturers licensed for hormone therapy production.
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Authorized Contract Manufacturers: Some pharmaceutical companies outsource manufacturing to specialized contract manufacturing organizations (CMOs) that comply with Good Manufacturing Practices (GMP). These CMOs hold the necessary regulatory approvals to produce active pharmaceutical ingredients (APIs) and finished formulations.
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Regional Production Facilities: Regional manufacturing hubs in Europe, North America, and Asia ensure localized supply and compliance with regional regulatory demands. Key facilities are inspected and certified to meet international standards (ICH-GMP).
Authorized Distributors and Suppliers
1. Pharmaceutical Wholesalers and Distributors
Authorized pharmaceutical distributors play a critical role in the supply chain, connecting manufacturers with healthcare providers and pharmacies. Noteworthy players include:
- AmerisourceBergen, McKesson, Cardinal Health (North America)
- Alliance Healthcare (now part of Walgreens Boots Alliance) (Europe)
- Phoenix Pharmaceutical (Specialized distributors in certain regions)
These distributors are linked via licensing agreements and certification standards, ensuring the authenticity and safety of the products supplied.
2. Licensed API Suppliers
For compounded or custom formulations, certified API suppliers provide the necessary raw materials. Reputable API suppliers include:
- Fresenius Kabi
- Sigma-Aldrich (now part of Merck)
- Cambridge Commodities
Ensuring APIs are sourced from GxP-certified suppliers minimizes contamination risks and guarantees pharmacological efficacy.
3. Regional and National Regulatory Agencies
Suppliers must hold appropriate licenses from national regulatory authorities. For example:
- FDA Registration (U.S.)
- EMA Certification (Europe)
- PMDA (Japan)
Professionals seeking CERIANNA should verify supplier registration and compliance via these agencies’ databases.
Key Attributes of Reliable CERIANNA Suppliers
- Regulatory Compliance: Suppliers must adhere to GMP, GDP, and regional Good Pharmacovigilance standards.
- Authenticity and Traceability: Verifying supplier legitimacy via certificates of authenticity, batch testing reports, and serial traceability systems.
- Supply Chain Security: Establishing contracts with distributors who employ cold chain logistics (if necessary) and cybersecurity measures for supply chain integrity.
- Market Authorization: Ensuring the product has the necessary approvals for legal sale in the target jurisdiction.
Emerging Trends and Considerations
Global Supply Chain Challenges
Recent disruptions, such as the COVID-19 pandemic and geopolitical tensions, have spotlighted vulnerabilities in pharmaceutical supply chains. For CERIANNA, this underscores the importance of diversified sourcing and local manufacturing capabilities.
Regulatory Harmonization
The global shift towards harmonized standards simplifies supplier verification. Initiatives like the International Pharmaceutical Regulators Programme (IPRP) support this effort.
Generic and Biosimilar Competition
In some markets, generic versions of CERIANNA may be produced by multiple manufacturers. Differentiating sources based on regulatory approvals and batch quality becomes vital.
Procurement Advice for Business Professionals
- Due Diligence: Conduct rigorous supplier audits, including GMP compliance audits and product verification checks.
- Supplier Qualification: Prioritize suppliers with proven traceability, regulatory certifications, and a history of reliable delivery.
- Partnerships: Establish long-term relationships with regional distributors to ensure consistent supply and rapid response to demand fluctuations.
- Risk Management: Implement contingency plans to mitigate risks associated with supply interruptions, including maintaining safety stock levels and diversifying suppliers.
Key Takeaways
- CERIANNA's supply chain relies on a combination of original manufacturers, contract manufacturers, and authorized distributors meeting stringent regulatory standards.
- Verifying supplier authenticity through certifications, regulatory approvals, and quality assurance reports is critical to maintaining product integrity.
- Global supply chain disruptions necessitate diversified sourcing strategies and strong regulatory compliance practices.
- Emerging trends favor regional manufacturing and harmonized standards, enhancing supply security.
- Thorough due diligence and supplier qualification programs are essential to mitigate risks and ensure continuous supply.
FAQs
1. Who are the primary manufacturers of CERIANNA?
CERIANNA is produced by licensed pharmaceutical companies specializing in hormonal therapies, with some production outsourced to certified CMOs. Specific manufacturer identities may vary based on regional licensing agreements.
2. How can I verify if a CERIANNA supplier is authorized?
Verify supplier authorization through national regulatory agencies’ databases (e.g., FDA, EMA). Request certificates of authenticity, batch testing reports, and GxP compliance documentation.
3. Are there regional differences in CERIANNA supply chains?
Yes. Supply chains differ regionally due to regulatory requirements, manufacturing facilities, and market approvals, influencing sourcing options and logistics.
4. What are common risks associated with CERIANNA supply chains?
Risks include supply disruptions, counterfeit products, regulatory non-compliance, and logistical delays. Due diligence and diversified sourcing mitigate these risks.
5. How might future trends impact CERIANNA suppliers?
Trends such as regulatory harmonization, local manufacturing incentives, and supply chain digitization will influence supplier viability, reliability, and distribution efficiency.
References
[1] U.S. Food and Drug Administration (FDA) Drug Approvals and Registrations, 2023.
[2] European Medicines Agency (EMA) Certification and Market Authorization Data, 2023.
[3] IQVIA Global Healthcare Data, 2023.
[4] Good Manufacturing Practice (GMP) Regulations, ICH Guidelines, 2022.
[5] Industry reports on pharmaceutical supply chain resilience, Pharma Intelligence, 2023.
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