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Suppliers and packagers for BLISOVI 24 FE
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BLISOVI 24 FE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Lupin Ltd | BLISOVI 24 FE | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 091398 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-864-73 | 3 BLISTER PACK in 1 CARTON (68180-864-73) / 1 KIT in 1 BLISTER PACK | 2019-11-07 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: BLISOVI 24 FE
Introduction
In the dynamic landscape of pharmaceutical manufacturing and distribution, understanding the supply chain for key medications is essential for businesses, healthcare providers, and regulatory entities. BLISOVI 24 FE, a combination medication primarily indicated for hormonal therapy, particularly in menopause management, relies heavily on a global network of suppliers that ensure its quality, efficacy, and safety. This analysis provides a comprehensive overview of the primary suppliers involved in the production and distribution of BLISOVI 24 FE, highlighting their roles, geographic locations, and strategic significance.
Drug Overview and Composition
BLISOVI 24 FE is a branded pharmaceutical product combining estrogen and progestin components. Its formulation typically includes Estradiol valerate and Drospirenone, both synthetic hormones used in hormone replacement therapy (HRT). The drug is manufactured following stringent regulatory standards, often requiring complex supply chains for raw materials, active pharmaceutical ingredients (APIs), excipients, and finished product manufacturing.
The commercial success of BLISOVI 24 FE hinges on multiple supply chain components, including API sourcing, formulation, packaging, and distribution. Its manufacturers must adhere to Good Manufacturing Practices (GMP), ensuring the integrity of supply from raw material procurement to final distribution.
Key Raw Material Suppliers
1. Active Pharmaceutical Ingredients (APIs)
The core APIs—Estradiol valerate and Drospirenone—are sourced globally, predominantly from regions with advanced chemical manufacturing industries such as Europe, India, and China.
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European API Suppliers
Several European companies, including Fresenius Kabi and Cetylite Industries, produce high-purity APIs adhering to rigorous EMA standards. European suppliers are favored for their compliance and reliable quality controls. -
Indian API Suppliers
India’s pharmaceutical industry has emerged as a major API supplier, with companies such as Biochem Pharmaceutical Industries, Hetero Labs, and Cipla manufacturing estrogen and progestin APIs. Indian suppliers offer cost-effective alternatives while maintaining quality standards recognized globally. -
Chinese API Suppliers
While less dominant for these specific APIs, some Chinese chemical manufacturers provide intermediates and raw materials used in API synthesis, often catering to Asian markets or supplying for global production through partnerships.
2. Excipients and Fillers
Suppliers of excipients such as magnesium stearate, lactose, and microcrystalline cellulose are diversified across Asia and Europe. Notable suppliers include JRS Pharma and DFE Pharma, known for high-quality pharmaceutical excipients.
Manufacturing and Filling
The finished dosage form of BLISOVI 24 FE involves formulation, tablet compression, coating, and packaging:
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Contract Manufacturing Organizations (CMOs)
Many pharmaceutical companies rely on CMOs for formulation and manufacturing processes. Major global players such as Recipharm, Patheon (Thermo Fisher Scientific), and Samsung Biologics have facilities capable of producing oral contraceptives and hormone therapies. -
Packaging Suppliers
Packaging suppliers, including companies like Bericap and Schott, provide blister packs, bottles, and labeling solutions compliant with regulatory standards.
Distribution Network and Logistics
The distribution of BLISOVI 24 FE involves a multi-tier network:
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Wholesalers and Distributors
Large pharmaceutical distributors such as McKesson, AmerisourceBergen, and regional wholesalers handle inventory management, compliance, and delivery to clinics and pharmacies. -
Regulatory and Import/Export Intermediaries
Regulatory bodies and import/export agencies facilitate cross-border trade, ensuring adherence to country-specific pharmacovigilance and quality regulations.
Regional Suppliers and Key Market Players
The primary providers of BLISOVI 24 FE include:
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Laboratories and Pharmaceutical Companies
- Pfizer, Gedeon Richter, and Mylan are major international players involved in licensing, manufacturing, or distribution partnerships for estrogen/progestin formulations globally.
- Local manufacturers in emerging markets often produce generic versions under licensing agreements.
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Licensed Distributors in Key Markets
Distributors operate in the U.S., Europe, Asia-Pacific, and Latin America to supply hospitals and retail pharmacies, ensuring steady availability.
Regulatory Considerations and Quality Assurance
Suppliers of BLISOVI 24 FE must comply with international standards such as EMA, FDA, and WHO GMP guidelines. Ensuring supplier compliance with these standards minimizes risks of contamination, adulteration, or supply disruptions.
Manufacturers often employ third-party quality audits, supplier qualification programs, and ongoing quality assurance testing of raw materials and finished goods.
Emerging Trends and Supply Chain Resilience
Recent disruptions caused by global events (e.g., COVID-19 pandemic) have underscored the importance of diversified supplier bases and regional manufacturing redundancies. Suppliers investing in regional API manufacturing and flexible logistic arrangements are better positioned to meet demand fluctuations.
The trend toward vertical integration—where manufacturers control API sourcing and formulation—enhances supply security for BLISOVI 24 FE, reducing dependence on external suppliers.
Conclusion
The supply chain for BLISOVI 24 FE is complex and globally distributed. It involves multiple layers of suppliers, from raw material producers (API and excipients) to contract manufacturers and distributors. Key regions include Europe, India, and China, with strategic partnerships and stringent quality controls underpinning secure supply chains. Continuous monitoring of geopolitical, regulatory, and market shifts remains essential for stakeholders aiming to safeguard the availability of this critical hormonal therapy.
Key Takeaways
- Diverse API sourcing from Europe, India, and China mitigates supply risks for BLISOVI 24 FE.
- Partnerships with reputable CMOs ensure high-quality formulation and manufacturing standards.
- Robust quality assurance protocols across the supply chain minimize regulatory and safety risks.
- Regional manufacturing expansion enhances supply chain resilience post-pandemic.
- Regulatory alignment with EMA, FDA, and WHO standards is critical for global distribution.
FAQs
1. Who are the main suppliers of the active ingredients for BLISOVI 24 FE?
The primary API suppliers include companies from Europe (e.g., Fresenius Kabi), India (e.g., Cipla, Hetero Labs), and China. These suppliers provide high-purity Estradiol valerate and Drospirenone essential for manufacturing BLISOVI 24 FE.
2. How does the supply chain ensure the quality of BLISOVI 24 FE?
Manufacturers conduct rigorous supplier qualification, GMP compliance checks, and continuous quality testing of raw materials and finished products. Regulatory audits and adherence to EMA, FDA, and WHO standards are standard.
3. Are there regional differences in suppliers for BLISOVI 24 FE?
Yes. Developed markets often rely on established European and North American suppliers, while emerging markets may utilize regional Indian or Chinese suppliers for cost efficiencies.
4. What role do CMOs play in the BLISOVI 24 FE supply chain?
CMOs handle formulation, tablet compression, coating, and packaging, enabling pharmaceutical companies to scale production swiftly and meet regional demand without extensive internal infrastructure.
5. How are supply chain disruptions being addressed for BLISOVI 24 FE?
Manufacturers diversify API sources, establish regional manufacturing hubs, and adopt flexible logistics solutions to minimize disruptions caused by geopolitical or global health crises.
References
- European Medicines Agency. (2022). Good Manufacturing Practice for Medicinal Products.
- U.S. Food and Drug Administration. (2022). Guidance for Industry: Quality Systems Approach to Pharmaceutical Quality.
- Indian Pharmaceutical Alliance. (2021). API Manufacturing Landscape in India.
- WHO. (2022). WHO Guidelines on Good Manufacturing Practices.
- Market research reports. (2023). Global API Market Analysis and Trends.
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