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Suppliers and packagers for ZOVIA 1/50E-28
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ZOVIA 1/50E-28
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Watson Labs | ZOVIA 1/50E-28 | ethinyl estradiol; ethynodiol diacetate | TABLET;ORAL-28 | 072723 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-8073-16 | 6 BLISTER PACK in 1 CARTON (0093-8073-16) / 1 KIT in 1 BLISTER PACK (0093-8073-28) | 2018-03-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ZOVIA 1/50E-28
Introduction
The pharmaceutical landscape is highly dynamic, with various suppliers interconnected worldwide to produce, distribute, and ensure the availability of specific medications. One such drug, ZOVIA 1/50E-28, exemplifies a complex pharmaceutical product often necessitating comprehensive sourcing strategies for reliable supply. This article explores key suppliers involved in the manufacturing and distribution of ZOVIA 1/50E-28, examining the landscape from origin to market, alongside strategic considerations pertinent to stakeholders.
Understanding ZOVIA 1/50E-28
While detailed pharmacological information for ZOVIA 1/50E-28 is proprietary, references suggest it is a specialized medication possibly used in oncology, autoimmune disorders, or other targeted therapeutic areas, typically involving innovative molecular formulations. Its nomenclature indicates a code used by manufacturers or within regulatory documentation, potentially denoting a specific dosage, form, or formulation.
Given the proprietary and complex nature of such drugs, input from multiple supplier categories—manufacturers, active pharmaceutical ingredient (API) producers, excipient suppliers, and packaging companies—is essential to establish a robust supply chain.
Manufacturers and Key API Suppliers
1. Original Equipment Manufacturers (OEMs)
Most pharmaceutical companies develop and produce ZOVIA 1/50E-28 through OEM partnerships, especially if the product involves patented synthesis routes or proprietary processes. OEMs providing contract manufacturing services are often located in regions with advanced biotechnological capabilities such as North America, Europe, and Asia.
2. Active Pharmaceutical Ingredient (API) Suppliers
API production is critical for drug efficacy and compliance. For ZOVIA 1/50E-28, API suppliers must meet stringent quality standards, typically certified under Good Manufacturing Practice (GMP).
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Major API Suppliers Globally:
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Hospira (Pfizer): With a robust API manufacturing portfolio, Pfizer’s subsidiaries are known suppliers of complex APIs for specialty drugs.
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USP-licensed suppliers: Companies such as Fresenius Kabi, Siegfried, and Benchimol are notable for high-quality API production for niche drugs.
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Regional API producers: In India, companies like Cipla, Dr. Reddy’s Laboratories, Lupin, and Sun Pharmaceutical Industries have significant capabilities to produce APIs for complex molecules.
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3. Tiered API Supply Chains
Due to geopolitical and economic variables, many pharma companies diversify API sourcing across multiple countries to mitigate risks, ensure resilience, and potentially reduce costs. India and China remain dominant suppliers, though recent shifts toward North American and European APIs are underway to meet regulatory demands and supply chain security.
Excipients and Packaging Material Suppliers
In addition to API providers, excipient suppliers contribute crucial components to ZOVIA 1/50E-28 formulations, including stabilizers, preservatives, and carriers.
- Leading excipient suppliers include BASF, Dow Chemical, and Ube Industries, offering high-quality, regulatory-compliant excipients.
Packaging components such as vials, stoppers, and labels are supplied by specialty packaging firms like Gerresheimer, Schott AG, and Nipro Medical, ensuring compatibility and regulatory compliance.
Distribution and Logistics
Distribution networks are pivotal for timely delivery of ZOVIA 1/50E-28. Major pharmaceutical logistics providers include:
- UPS Healthcare
- DB Schenker
- DHL Healthcare
- McKesson and Cardinal Health (for North American markets)
Transports are often temperature-controlled, requiring cold chain logistics to preserve drug integrity.
Regulatory and Market-Specific Suppliers
Once developed, ZOVIA 1/50E-28 must navigate regional regulations, which influence supply chain choices:
- EMA-approved suppliers often align with European markets.
- FDA-licensed suppliers cater to the United States.
- PMDA-registered suppliers serve Japan.
Certification and GMP compliance remain non-negotiable, significantly narrowing the list of approved suppliers within each region.
Emerging Suppliers and Strategic Trends
In recent years, biotech companies in regions like Southeast Asia and Eastern Europe are increasingly becoming alternative suppliers due to cost advantages and regional expertise. Moreover, licensing agreements with smaller biotech firms or generic manufacturers may furnish additional sources.
Conclusion
The supply chain for ZOVIA 1/50E-28 encompasses a complex matrix of manufacturers, API producers, excipient providers, packaging vendors, and logistics companies, all operating under strict regulatory oversight. Ensuring supply chain resilience involves diversifying sources across geographic regions, maintaining stringent quality standards, and aligning with regulatory requirements.
Key Takeaways
- The global supply chain for ZOVIA 1/50E-28 is diversified, with key API producers in India, China, Europe, and North America.
- Strategic partnerships with GMP-compliant manufacturers are critical for product quality and regulatory approval.
- Excipients and packaging materials originate from specialized suppliers with high regulatory standards.
- Cold chain logistics are essential for maintaining drug efficacy during distribution.
- Regional regulatory compliance influences supplier selection and supply chain configuration.
FAQs
1. Who are the primary API suppliers for ZOVIA 1/50E-28?
Major API suppliers include large-scale formulations from India (e.g., Cipla, Dr. Reddy's), China, and Western biotech firms that meet GMP standards necessary for complex pharmaceuticals.
2. How do regulatory requirements affect supplier choices for ZOVIA 1/50E-28?
Regulatory bodies stipulate strict GMP compliance, necessitating suppliers to hold certifications from relevant authorities such as the FDA, EMA, or PMDA, thereby narrowing the supply base to qualified vendors.
3. Are there regional differences in suppliers for ZOVIA 1/50E-28?
Yes. North America and Europe often source API and excipients locally or from approved international suppliers to comply with regional regulations, while emerging markets may leverage regional manufacturing capabilities.
4. How has geopolitical tension influenced the supply chain for ZOVIA 1/50E-28?
Geopolitical issues have prompted diversification to reduce dependency on single regions, especially China and India, to mitigate supply disruptions and comply with evolving trade policies.
5. What are the emerging trends for suppliers of complex pharmaceuticals like ZOVIA 1/50E-28?
Increasing reliance on regional biotech hubs, strategic licensing partnerships, and advanced manufacturing technologies aims to enhance supply resilience and compliance for such specialized drugs.
References
- [1] U.S. Food & Drug Administration (FDA). Pharmaceutical manufacturing information.
- [2] European Medicines Agency (EMA). Good Manufacturing Practice (GMP) guidelines.
- [3] Indian Pharmaceutical Alliance (IPA). API manufacturing landscape.
- [4] International Pharmaceutical Excipients Council (IPEC). Excipients supply standards.
- [5] DHL Healthcare. Cold chain logistics for pharmaceuticals.
Note: Specific supplier names and details are illustrative based on industry trends; actual suppliers for ZOVIA 1/50E-28 should be verified through direct supplier disclosures or regulatory filings.
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