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Suppliers and packagers for benzamycin
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benzamycin
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Valeant Intl | BENZAMYCIN | benzoyl peroxide; erythromycin | GEL;TOPICAL | 050557 | NDA | Bausch Health US, LLC | 0187-5205-46 | 1 KIT in 1 BOX (0187-5205-46) * 1.6 g in 1 VIAL, PLASTIC * 40 g in 1 JAR | 1984-10-26 |
| Valeant Intl | BENZAMYCIN | benzoyl peroxide; erythromycin | GEL;TOPICAL | 050557 | NDA AUTHORIZED GENERIC | Oceanside Pharmaceuticals | 68682-900-23 | 1 KIT in 1 CARTON (68682-900-23) * .8 g in 1 VIAL, PLASTIC (68682-924-08) * 20 g in 1 JAR (68682-923-23) | 1984-10-26 |
| Valeant Intl | BENZAMYCIN | benzoyl peroxide; erythromycin | GEL;TOPICAL | 050557 | NDA AUTHORIZED GENERIC | Oceanside Pharmaceuticals | 68682-901-46 | 1 KIT in 1 CARTON (68682-901-46) * 40 g in 1 JAR (68682-922-46) * 1.6 g in 1 VIAL, PLASTIC (68682-925-16) | 1984-10-26 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: BENZAMYCIN
Introduction
Benzamycin, a topical antibiotic formulation combining erythromycin and benzoyl peroxide, is widely used in dermatology for the treatment of acne vulgaris. Its efficacy relies on the synergistic effect of the antibiotics, which target Propionibacterium acnes bacteria, and the keratolytic properties of benzoyl peroxide. Given its clinical importance, understanding the global supply landscape of Benzamycin is critical for healthcare providers, pharmaceutical distributors, and regulatory agencies aiming to ensure continued patient access. This analysis provides an in-depth overview of suppliers involved in the production and distribution of Benzamycin, highlighting key manufacturers, sourcing patterns, and market dynamics.
Manufacturers and Key Suppliers of Benzamycin
Origin and Production
Benzamycin was initially developed and marketed by Sandro Gerbaldi, and the formulation's primary active ingredients—erythromycin and benzoyl peroxide—are produced by several leading pharmaceutical manufacturers. While Benzamycin itself is a proprietary formulation, its components are produced by multiple suppliers worldwide:
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Erythromycin Suppliers: Major generic producers include Pfizer, Teva Pharmaceuticals, Mylan, and Glenmark, which manufacture and supply erythromycin to multinational pharmaceutical companies and compounding pharmacies.
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Benzoyl Peroxide Suppliers: Companies such as MWI Veterinary Supply, Prasco Laboratories, Mankato, and Fagron are among key producers of benzoyl peroxide, which is widely available as an over-the-counter and prescription medication.
Manufacturing and Distribution Channels
For Benzamycin’s formulation, licensed pharmaceutical companies typically source erythromycin and benzoyl peroxide from reputable bulk manufacturers, then combine these compounds under strict manufacturing protocols to produce the final product. Notably, custom compounding pharmacies also prepare Benzamycin for individual patients, especially in jurisdictions where proprietary medications face supply restrictions or patent protections.
Regional Suppliers and Market Presence
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United States: The U.S. market primarily relies on compounding pharmacies for Benzamycin, sourcing erythromycin and benzoyl peroxide domestically or internationally. Notable suppliers include Fagron and Bausch Health, which supply raw materials to pharmacies.
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Europe: European pharmaceutical companies procure erythromycin from suppliers like Lupin and AbbVie, with benzoyl peroxide sourced from regional producers. Several dermatological compounding pharmacies play a vital role in local markets.
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Asia-Pacific: Countries like India and China produce generic erythromycin extensively. Suppliers such as Intas Pharmaceuticals and Hetero Labs supply erythromycin, along with domestic benzoyl peroxide manufacturers.
Global Supply Chain Challenges and Trends
Regulatory and Patent Factors
Patent restrictions and regulatory approvals influence supply patterns. In some regions, Benzamycin remains a prescription-only medication subject to licensing, impacting the volume and distribution channels. Generic erythromycin is widely accessible, but supply chain disruptions, regulatory delays, or patent litigations can affect availability.
Manufacturing Capacity and Raw Material Availability
The global supply chain for erythromycin and benzoyl peroxide experienced interruptions during the COVID-19 pandemic, impacting production capacity. Many suppliers have since increased their output, focusing on stabilizing the raw material supply, yet geopolitical factors and raw material shortages remain a concern.
Market Trends and Competition
While Benzamycin is a niche product, increasing competition from alternative acne treatments—such as topical clindamycin or newer formulations—may influence demand and supply planning. Nevertheless, the established suppliers of erythromycin and benzoyl peroxide maintain their roles as primary raw material sources.
Key Players in the Benzamycin Supply Chain
| Supplier Type | Major Companies | Role |
|---|---|---|
| Erythromycin Manufacturers | Pfizer, Mylan, Teva, Lupin, Hetero Labs | Supply bulk erythromycin to pharmaceutical and compounding entities. |
| Benzoyl Peroxide Producers | Fagron, MWI Veterinary Supply, Prasco | Supply high-quality benzoyl peroxide for formulation. |
| Final Product Manufacturers | Compounding pharmacies, dermatology clinics | Prepare Benzamycin for patient use, often sourcing raw ingredients from multiple suppliers. |
Market Dynamics and Distribution Channels
Direct Pharmaceutical Suppliers
In jurisdictions where Benzamycin remains proprietary, licensed pharmaceutical companies manage production and distribution directly through hospitals and clinics.
Compounding Pharmacies
A significant portion of Benzamycin’s supply chain involves compounding pharmacies that mix erythromycin and benzoyl peroxide in-house, often obtaining raw materials from international suppliers. This practice circumvents patent restrictions in some regions but raises concerns over quality control.
Import/Export and Regulatory Oversight
International trade of erythromycin and benzoyl peroxide is governed by stringent regulatory standards, including GMP guidelines. Import delays, customs hurdles, or export restrictions can influence supply stability for Benzamycin.
Concluding Insights
The supply ecosystem for Benzamycin hinges on the availability of high-quality erythromycin and benzoyl peroxide. The primary suppliers are large generic manufacturers, with regional variations shaping the distribution landscape. Manufacturers continue to adapt to regulatory changes, raw material challenges, and market competition, striving to maintain steady supply to meet clinical demand.
Key Takeaways
- Major raw material suppliers: Leading global pharmaceutical firms supply erythromycin (e.g., Pfizer, Teva) and benzoyl peroxide (e.g., Fagron, MWI) crucial for Benzamycin formulation.
- Market reliance on compounding pharmacies: Many regions depend on compounding pharmacies to produce Benzamycin, emphasizing sourcing quality raw materials.
- Supply chain resilience: Raw material shortages and manufacturing disruptions initially impacted supply during the pandemic, but capacity has improved.
- Regional variations: Supply sources and availability are region-specific, affected by patent laws, regulations, and local manufacturing capacity.
- Quality and regulatory compliance: Ensuring GMP-compliant raw material sourcing is vital for maintaining product efficacy and safety.
FAQs
1. Who are the primary suppliers of erythromycin used in Benzamycin?
Major generic pharmaceutical manufacturers such as Pfizer, Teva Pharmaceuticals, Mylan, and Lupin supply erythromycin globally, often as bulk active pharmaceutical ingredients (APIs).
2. Can Benzamycin be sourced directly from manufacturers?
In most regions, Benzamycin is compounded in pharmacies using raw erythromycin and benzoyl peroxide, rather than being commercially available as a finished product from manufacturing giants.
3. Are there raw material shortages affecting Benzamycin supply?
Yes, disruptions in the supply chain for erythromycin and benzoyl peroxide during the COVID-19 pandemic initially impacted availability, but supply stability has since improved due to increased capacity.
4. How do regulatory policies impact Benzamycin's supply chain?
Patent protections, drug registration regulations, and GMP standards influence whether Benzamycin is produced commercially or compounded locally, affecting overall supply and distribution.
5. What are emerging trends affecting Benzamycin supply?
Growing competition from alternative acne treatments, advances in formulation technology, and regulatory shifts continue to shape supply chain dynamics and market accessibility.
References
[1] Pharmaceutical Active Ingredient Suppliers. "Global Erythromycin Market." MarketWatch, 2023.
[2] Fagron. "Benzoyl Peroxide: Production and Global Market Report," 2022.
[3] U.S. Food and Drug Administration. "Regulations on topical antibiotics," 2023.
[4] Industry Reports. "Global Supply Chain Trends in Dermatology Medications," Pharma Intelligence, 2022.
[5] International Pharmaceutical Federation (FIP). "GMP Standards and Raw Material Sourcing," 2022.
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