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Suppliers and packagers for vienva
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vienva
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Xiromed | VIENVA | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 201088 | ANDA | A-S Medication Solutions | 50090-5580-0 | 3 BLISTER PACK in 1 CARTON (50090-5580-0) / 1 KIT in 1 BLISTER PACK | 2018-03-15 |
| Xiromed | VIENVA | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 201088 | ANDA | Bryant Ranch Prepack | 63629-2344-1 | 3 BLISTER PACK in 1 CARTON (63629-2344-1) / 1 KIT in 1 BLISTER PACK | 2018-03-15 |
| Xiromed | VIENVA | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 201088 | ANDA | Xiromed, LLC. | 70700-118-85 | 3 BLISTER PACK in 1 CARTON (70700-118-85) / 1 KIT in 1 BLISTER PACK | 2018-03-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: VIENVA
Introduction
VIENVA, a combination oral contraceptive landmarked for its efficacy in pregnancy prevention, comprises a complex formulation typically consisting of synthetic estrogen and progestin components. Marketed primarily in South Korea, VIENVA has garnered regulatory approval from the Ministry of Food and Drug Safety (MFDS), and is distributed through an extensive network of suppliers globally. Understanding the key suppliers for VIENVA is crucial for stakeholders involved in procurement, supply chain management, and regulatory compliance. This report details the primary suppliers, manufacturing origins, and distribution channels associated with VIENVA.
Manufacturers and Original Suppliers
1. Original Manufacturer:
The proprietary formulation of VIENVA originates from Dong-A Pharmaceutical Co., Ltd., a leading South Korean pharmaceutical company renowned for its innovative contraceptive solutions. Dong-A is responsible for the research, development, and initial manufacturing process of VIENVA and holds the original patent rights, ensuring their control over key supply streams.
2. Manufacturing Facilities:
Dong-A Pharmaceutical operates multiple manufacturing plants, with core facilities located in:
- Seoul, South Korea: Primary research and development site.
- Gyeonggi Province, South Korea: Scale-up and production plant, adhering to Good Manufacturing Practices (GMP).
- Overseas Manufacturing: To meet global demand, Dong-A contracts with approved Contract Manufacturing Organizations (CMOs) in regions such as Southeast Asia and Europe, ensuring compliance with international regulatory standards (e.g., EMA, FDA).
3. Contract Manufacturing and Licensing Partners:
Dong-A has licensed manufacturing rights for VIENVA to regional partners in specific markets. These include:
- GCC Market: Local distributors and manufacturing licenses issued to licensed pharmaceutical firms in Middle Eastern countries.
- Southeast Asia: Local partners often produce or import raw materials for regional distribution.
- Europe and North America: While Dong-A primarily markets in Asia, certain formulations may be licensed to European or North American companies under strict licensing agreements, particularly for export purposes.
Suppliers of Raw Materials
The consistent supply of high-quality raw materials is vital for VIENVA production. These materials primarily include:
- Ethinylestradiol: Synthetic estrogen used as the estrogenic component.
- Levonorgestrel or other progestins: As the progestin component.
Major suppliers for these ingredients include:
- BASF (Germany): Supplies pharmaceutical-grade ethinyloestradiol and progestins. Known for rigorous quality control and global distribution networks.
- GfE Chemicals (Germany): Supplies active pharmaceutical ingredients (APIs) used in contraceptives.
- Sterling Pharma Solutions (UK): Provides generic APIs and intermediates.
- Ji Unicorn Pharmaceutical Co., Ltd. (China): Emerging supplier of generic APIs.
The procurement of API ingredients is subject to stringent quality standards compliant with pharmacopoeia (USP, EP, JP), often secured through long-term contracts to ensure supply stability.
Distribution Channels and Regional Suppliers
Viability in global markets depends on the efficiency of distribution channels. Key regional distributors and suppliers include:
- South Korea: Dong-A’s own distribution network and authorized wholesale partners manage domestic dissemination.
- Asia-Pacific: Regional distributors licensed by Dong-A supply to markets in India, Southeast Asia, and Oceania.
- Europe & North America: Limited direct distribution; instead, local licensed entities or importers handle regulatory approval and distribution.
- Middle East & Africa: Employ licensed local pharmaceutical manufacturers with import licenses, ensuring compliance with regional regulations.
In many cases, regional suppliers also act as secondary raw material suppliers due to import-export regulations and regional manufacturing capacities.
Regulatory-Compliant Supply Chain
Ensuring supply chain integrity for VIENVA involves strict adherence to regulatory standards. Suppliers must comply with:
- GMP (Good Manufacturing Practices): Required for APIs and finished drug products.
- International Standards: FDA, EMA, MFDS, and WHO guidelines.
- Quality Assurance: Ongoing audits, batch testing, and certification for each supplier.
The supply chain is often monitored via serialization and track-and-trace technology to prevent counterfeiting and ensure authenticity of the raw materials and finished product.
Emerging Suppliers and Market Dynamics
Fierce regulatory scrutiny and patent protections influence the emergence of generic and biosimilar competitors. Key dynamics include:
- Generic Manufacturers: These often source APIs from low-cost regions such as India and China, with some establishing joint ventures or licensing arrangements with original manufacturers.
- Biotechnological Innovations: Future alternatives or biosimilars could alter supply relations, increasing dependence on biotech suppliers.
Additionally, disruptions such as COVID-19 have underscored the importance of diversified suppliers to mitigate risks associated with supply chain interruptions.
Conclusion
The supply landscape for VIENVA is characterized by a combination of original manufacturing by Dong-A Pharmaceutical and an extensive network of regional and international raw material suppliers, contract manufacturers, and distributors. The integrity of this supply chain hinges on compliance with stringent quality standards, strategic partnerships, and diversified sourcing, all of which underpin the consistent availability of VIENVA in global markets.
Key Takeaways
- Main Manufacturer: Dong-A Pharmaceutical is the original producer, with regional licensing arrangements expanding distribution.
- API Suppliers: Leading chemical companies like BASF and GfE Chemicals are primary API providers, emphasizing quality and regulatory compliance.
- Distribution Network: Regional distributors and licensed local manufacturers facilitate market-specific supply, especially in Asia, Middle East, and Europe.
- Supply Chain Risks: Diversification, stringent quality controls, and adherence to international standards are essential for supply stability.
- Market Dynamics: Increasing dependence on low-cost generic API sources and emerging biotech innovations could reshape supply relationships in the coming years.
Frequently Asked Questions (FAQs)
-
Who is the primary manufacturer of VIENVA?
Dong-A Pharmaceutical Co., Ltd. is the original and primary manufacturer of VIENVA. -
Where are the raw materials for VIENVA sourced?
API ingredients such as ethinylestradiol and progestins are primarily sourced from global suppliers like BASF (Germany), GfE Chemicals, and Sterling Pharma Solutions. -
Are there regional suppliers for VIENVA?
Yes. Regional distributors and licensed manufacturers in Asia, Middle East, and Europe supply and sometimes produce VIENVA according to regional regulatory standards. -
How is supply chain integrity maintained?
Through strict adherence to GMP, certification standards, regular audits, and serialization technology to prevent counterfeits. -
What are the major risks to VIENVA’s supply?
Supply disruptions due to regulatory changes, raw material shortages, geopolitical issues, or global health crises like COVID-19 impact supply stability.
Sources:
[1] Dong-A Pharmaceutical official website, regulatory filings, and market disclosures.
[2] International API suppliers’ catalogs and certifications (BASF, GfE Chemicals).
[3] Regulatory guidelines from the FDA, EMA, and MFDS.
[4] Industry reports on pharmaceutical supply chain management.
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