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Suppliers and packagers for locoid
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locoid
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bausch | LOCOID | hydrocortisone butyrate | LOTION;TOPICAL | 022076 | NDA AUTHORIZED GENERIC | Oceanside Pharmaceuticals | 68682-392-02 | 1 BOTTLE in 1 CARTON (68682-392-02) / 59 mL in 1 BOTTLE | 2018-06-08 |
| Precision Dermat | LOCOID | hydrocortisone butyrate | OINTMENT;TOPICAL | 018652 | NDA | Oceanside Pharmaceuticals | 68682-271-15 | 1 TUBE in 1 CARTON (68682-271-15) / 15 g in 1 TUBE | 2009-09-01 |
| Precision Dermat | LOCOID | hydrocortisone butyrate | OINTMENT;TOPICAL | 018652 | NDA | Oceanside Pharmaceuticals | 68682-271-45 | 1 TUBE in 1 CARTON (68682-271-45) / 45 g in 1 TUBE | 2009-09-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Locoid
Introduction
Locoid is a topical corticosteroid predominantly used to treat inflammatory and allergic skin conditions such as eczema, dermatitis, and psoriasis. The active ingredient in Locoid is hydrocortisone butyrate, a synthetic glucocorticoid with potent anti-inflammatory properties. As a significant product in dermatological pharmaceutics, its supply chain involves a network of manufacturers, distributors, and authorized suppliers worldwide. Understanding who supplies Locoid, their geographic reach, regulatory compliance, and market positioning is vital for healthcare providers, pharmaceutical distributors, and market analysts.
Manufacturers of Locoid
1. Bayer AG
Bayer AG, a leading global pharmaceutical company headquartered in Germany, holds the original patent and manufacturing rights for Locoid. With extensive expertise in dermatological dermatological products, Bayer has established a strong presence in the pharmaceutical markets across Europe, Asia, and North America.
- Production Facilities: Bayer's manufacturing plants in Germany, Germany, and the United States produce Locoid and other corticosteroids.
- Regulatory Approvals: Bayer ensures that Locoid complies with regulatory standards like the FDA (Food and Drug Administration) in the U.S. and EMA (European Medicines Agency) approvals in Europe.
2. Mylan (now part of Viatris)
Mylan, acquired by Viatris in late 2020, has been a key importer and distributor of Locoid in multiple regions, especially in countries where Bayer's direct distribution is limited.
- Commercial Presence: Mylan/Viatris supplies generic versions or authorized generics of hydrocortisone butyrate-based products under licensing agreements.
- Distribution Network: Their extensive global network ensures the availability of Locoid in over 150 countries, including emerging markets.
3. Sandoz (Novartis)
Sandoz, a division of Novartis, is another significant supplier involved in manufacturing or distributing hydrocortisone butyrate formulations.
- Manufacturing Capability: Sandoz produces dermatological corticosteroids, including Locoid equivalents, in facilities across Europe.
- Partnerships: They often collaborate with local distributors and healthcare authorities to ensure compliance and reliable supply.
4. Other Regional Suppliers
- Sun Pharmaceutical Industries: In India and parts of Southeast Asia, Sun Pharma supplies generic formulations similar to Locoid, calibrated to regional demand.
- Cipla, Dr. Reddy’s Laboratories: These firms produce hydrocortisone butyrate solutions for local and international markets.
Distribution Channels and Authorized Suppliers
The distribution of Locoid involves a tiered system, including wholesalers, pharmacy chains, and hospital supply networks:
- Pharmaceutical Wholesalers: Major players like McKesson, Cardinal Health, and Europe-based Alliance Healthcare distribute Locoid to pharmacies and clinics.
- Hospital Pharmacies: Direct procurement contracts with regional health authorities ensure supply in institutional settings.
- Online Pharmacies: Some licensed online dispensaries source Locoid from authorized suppliers, subject to regulatory restrictions.
Regulatory and Patent Status Impacting Supply
While the original patent for Locoid expired in several jurisdictions around 2020, manufacturers continue to hold exclusivity in specific countries due to geographical patent protections or regulatory exclusivities. This influences the number of suppliers and the degree of market competition:
- Patent Expiration: After patent expiry, generic manufacturers can produce bioequivalent formulations, increasing the supply scope.
- Regulatory Approvals: Suppliers must secure local regulatory approvals, which can vary. Some regions may restrict the import and distribution of unapproved generics.
Market Dynamics and Key Suppliers
Market Trends
- Generic Competition: The entry of multiple generic suppliers post-patent expiry has generally reduced prices and increased availability.
- Regional Variability: Supply chains are highly region-specific, driven by local manufacturing capabilities and regulatory frameworks.
- Supply Chain Challenges: Global disruptions, such as those caused by COVID-19, have underscored the importance of diversified suppliers to prevent shortages.
Key Players’ Market Share
- Bayer AG retains a significant share in Europe and North America due to brand strength and intellectual property rights.
- Viatris/Mylan leads in markets where licensed generics are prevalent.
- Regional pharmaceutical firms fulfill demand in Asia, Africa, and Latin America, often via licensing agreements or local manufacturing.
Quality Assurance and Compliance
Suppliers of Locoid are required to meet rigorous quality standards mandated by bodies like the FDA, EMA, and other national regulatory agencies:
- Good Manufacturing Practices (GMP): Ensures consistent product quality.
- Pharmacovigilance: Ongoing safety monitoring post-distribution.
- Traceability: Strong documentation and supply chain transparency help prevent counterfeit or substandard products.
Conclusion
The supply landscape for Locoid is characterized by a mix of established multinational pharmaceutical companies, regional manufacturers, and licensed distributors. Bayer AG remains a primary manufacturer globally, supported by licensed generic producers such as Mylan/Viatris, Sandoz, and regional players. Market dynamics are heavily influenced by patent statuses, regulatory approvals, and regional demand. Ensuring a reliable supply chain requires continuous monitoring of regulatory developments, market entries, and supply chain resilience strategies.
Key Takeaways
- Major manufacturers include Bayer AG, Viatris (formerly Mylan), and Sandoz, with regional manufacturers supplementing supply.
- Patent expiries have expanded the number of generic suppliers, increasing market competition and accessibility.
- Global supply chains are subject to regional regulatory frameworks, impacting availability.
- Quality control and compliance are critical, ensuring product safety and efficacy.
- Market intelligence and diversified supplier relationships mitigate risks of shortages and counterfeit products.
FAQs
1. Who is the original manufacturer of Locoid?
Bayer AG is the original manufacturer and patent holder for Locoid, with production facilities in Germany and the United States.
2. Are there generic versions of Locoid available?
Yes, post-patent expiration, several generic manufacturers, including Viatris (formerly Mylan), Sandoz, and regional firms, produce hydrocortisone butyrate formulations similar to Locoid.
3. How do supply chains for Locoid vary across regions?
Supply chains differ based on local patent laws, regulatory approvals, manufacturing capabilities, and market demand, with regional manufacturers often supplementing or replacing imports.
4. What factors influence the reliability of Locoid supply?
Regulatory approvals, patent statuses, manufacturing capacity, global disruptions (e.g., pandemics), and distribution infrastructure influence supply reliability.
5. How can healthcare providers ensure consistent access to Locoid?
By establishing relationships with multiple authorized distributors, monitoring regulatory environments, and adopting diversified procurement strategies, providers can ensure consistent access.
Sources:
[1] Bayer AG official website and product documentation.
[2] Viatris corporate reports and product listings.
[3] Sandoz product portfolio and regulatory filings.
[4] Regulatory agencies (FDA, EMA) databases for patent and approval statuses.
[5] Market analysis reports on dermatological pharmaceuticals and generic drug supply.
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