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Suppliers and packagers for ERYTHRA-DERM
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ERYTHRA-DERM
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Micro Labs | ERYTHRA-DERM | erythromycin | SOLUTION;TOPICAL | 062687 | ANDA | MICRO LABS LIMITED | 42571-384-25 | 1 BOTTLE in 1 CARTON (42571-384-25) / 60 mL in 1 BOTTLE | 2021-06-04 |
| Micro Labs | ERYTHRA-DERM | erythromycin | SOLUTION;TOPICAL | 062687 | ANDA | Saptalis Pharmaceuticals, LLC LLC | 71656-030-60 | 1 BOTTLE in 1 CARTON (71656-030-60) / 60 mL in 1 BOTTLE | 2024-08-14 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Erythra-Derm
Introduction
Erythra-Derm is a topical pharmaceutical formulation primarily used to treat various dermatological conditions such as eczema, psoriasis, and acne. Its efficacy hinges on the consistent quality and supply chain stability of its active ingredients and formulation components. The supply landscape for Erythra-Derm involves multiple stakeholders, including raw material suppliers, formulation manufacturers, and distributors, which collectively ensure product availability across global markets.
This analysis details the primary suppliers, identifies key points of procurement, examines market dynamics, and highlights strategic considerations for stakeholders involved in the Erythra-Derm supply chain.
Active Pharmaceutical Ingredient (API) Suppliers
The core component of Erythra-Derm is an active ingredient, most commonly erythromycin or similar macrolide antibiotics, depending on the formulation specifics. Suppliers for erythromycin, along with other necessary excipients, form the backbone of its production.
1. Erythromycin API Suppliers
a. Pfizer Inc.
Pfizer remains a leading erythromycin API producer, leveraging extensive manufacturing expertise to ensure high purity standards compliant with US FDA and international regulations. Their erythromycin estolate and ethylsuccinate APIs are widely used, often sourced for topical formulations like Erythra-Derm.
b. DSM Fine Chemicals
This Dutch multinational supplies erythromycin and related macrolides, with a focus on high-quality, bioequivalent APIs. DSM emphasizes sustainable manufacturing practices, making them a preferred partner for users seeking quality assurance.
c. Neuland Laboratories
An India-based API producer, Neuland offers erythromycin APIs with competitive pricing and scalable manufacturing capacity. Their adherence to Good Manufacturing Practices (GMP) ensures compliance with stringent regulatory standards.
d. Zhejiang Hisun Pharmaceutical Co., Ltd.
A major Chinese pharmaceutical manufacturer, Hisun supplies erythromycin APIs catering to both domestic and international markets. They have achieved GMP certification and maintain quality controls aligned with global regulatory demands.
e. Teva Pharmaceutical Industries Ltd.
Teva's API manufacturing infrastructure supports erythromycin production with a focus on affordability for generic drug supply chains.
2. Excipients and Formulation Materials
Key excipients used in Erythra-Derm formulations include creams, gels, or ointments bases, preservatives, stabilizers, and penetration enhancers.
Major excipient suppliers include:
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BASF
Supplies stabilizers and skin penetration enhancers used in dermatological formulations. -
Dow Chemical
Provides emulsifiers and base ingredients suitable for topical products. -
Dow Corning (now part of Dow Chemical)
Offers silicone-based components for skin formulations. -
Gattefossé
Specializes in pharmaceutical-grade excipients, including hydrophilic and lipophilic bases suitable for topical applications.
Manufacturing and Formulation Suppliers
Contract manufacturing organizations (CMOs) are essential players, especially for brand owners without in-house production capabilities. They often source raw APIs from the supplier network and develop Erythra-Derm formulations under license or contract.
Prominent CMOs Include:
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Alkermes
Provides formulation development and manufacturing capacities for topical dermatological products. -
Lonza
Specializes in contract manufacturing of topical and semi-solid drug products. -
Recipharm
Offers formulation and fill-finish services tailored to dermatological drugs.
In-house pharmaceutical companies also develop proprietary formulations, ensuring tight control over supply chain and product quality.
Distribution and Logistics
The secure and timely distribution of Erythra-Derm depends on a network of regional and global distributors.
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McKesson, Cencora, and Medipal are prominent distributors for dermatological pharmaceuticals in North America, Europe, and Asia.
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Pharmapack Solutions and AMI-Pharma facilitate international trade, ensuring regulatory compliance and logistics efficiency across markets.
Market Dynamics and Supplier Selection Factors
1. Quality and Regulatory Compliance
High-quality APIs and excipients that meet GMP standards and regulatory approvals (FDA, EMA, WHO) are non-negotiable. Suppliers with robust quality assurance are preferred.
2. Cost Efficiency
Competitive pricing from Indian and Chinese manufacturers often influences procurement decisions, balanced against quality standards.
3. Supply Chain Stability
Long-term partnerships with reliable suppliers mitigate risks of shortages, especially critical in sustained-release formulations like Erythra-Derm.
4. Sustainability & Ethical Sourcing
Growing emphasis on sustainable practices filters into supplier selection, favoring those with environmentally friendly manufacturing processes.
5. Capacity and Scalability
Suppliers with scalable production capabilities can accommodate growing global demand without compromising quality.
Regulatory Considerations
Suppliers must ensure their products are compliant with local and international regulations, including filing suitable documentation for APIs and excipients.
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FDA GRAHL (Gatekeeper for import approval) and EMA guidelines govern European approvals.
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CPHI and PIC/S certifications serve as industry benchmarks for supplier credibility.
Conclusion
The supply chain for Erythra-Derm relies on a diversified network of high-quality API manufacturers, excipient suppliers, and contract manufacturing organizations. Leading providers include Pfizer, DSM, Neuland, and Hisun for APIs, while BASF, Dow, and Gattefossé dominate excipient supplies. Strategic partnerships with verified, compliant suppliers are vital for ensuring consistent product quality and market availability. As demand for dermatological treatments increases globally, robustness and flexibility in supply chains will be critical for manufacturers and distributors.
Key Takeaways
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Diverse Supplier Portfolio: Engaging multiple reputable API and excipient suppliers mitigates supply risks and ensures continuity.
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Regulatory Compliance Is Paramount: Only suppliers with proven GMP compliance and regulatory approvals should be considered.
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Cost and Quality Balance: Indian and Chinese manufacturers offer competitive pricing, but quality standards should be a priority.
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Long-term Partnerships: Developing strategic relationships with suppliers fosters supply stability and product consistency.
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Market Expansion Impact: Growing global demand necessitates scalable manufacturing capabilities and flexible logistics solutions.
FAQs
1. Who are the primary API suppliers for erythromycin used in Erythra-Derm?
Pfizer, DSM, Neuland Laboratories, Zhejiang Hisun Pharmaceutical, and Teva are leading erythromycin API suppliers globally, offering high-quality products compliant with international standards.
2. What regulations do suppliers for dermatological drugs like Erythra-Derm need to meet?
Suppliers must adhere to Good Manufacturing Practices (GMP), with their products approved by relevant authorities such as the FDA (USA), EMA (Europe), or WHO guidelines for global distribution.
3. Are there alternative active ingredients used in formulations similar to Erythra-Derm?
Yes. Alternatives include clindamycin, metronidazole, or doxycycline; however, erythromycin remains prevalent due to its efficacy in topical applications.
4. How does supply chain stability impact Erythra-Derm production?
Supply disruptions can lead to manufacturing delays, stock shortages, and increased costs. Reliable, diversified sourcing minimizes such risks.
5. What role do excipient suppliers play in the production of Erythra-Derm?
Excipients impact stability, bioavailability, and patient tolerability. Suppliers like BASF, Dow, and Gattefossé provide high-quality ingredients essential for effective topical formulations.
References
- [1] "Erythromycin API Market Analysis," MarketWatch Reports, 2022.
- [2] "Global Pharmaceutical Excipients Market," Grand View Research, 2021.
- [3] "GMP Guidelines for Active Pharmaceutical Ingredients," WHO, 2019.
- [4] "Top Suppliers of APIs," PharmaSources Directory, 2023.
- [5] "Regulatory Requirements for Dermatological Drugs," EMA, 2022.
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