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Suppliers and packagers for ery-tab
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ery-tab
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Pharmobedient | ERY-TAB | erythromycin | TABLET, DELAYED RELEASE;ORAL | 062298 | ANDA | Arbor Pharmaceuticals, Inc. | 24338-122-03 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (24338-122-03) | 2011-04-18 |
| Pharmobedient | ERY-TAB | erythromycin | TABLET, DELAYED RELEASE;ORAL | 062298 | ANDA | Arbor Pharmaceuticals, Inc. | 24338-122-13 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (24338-122-13) | 2011-04-18 |
| Pharmobedient | ERY-TAB | erythromycin | TABLET, DELAYED RELEASE;ORAL | 062298 | ANDA | Arbor Pharmaceuticals, Inc. | 24338-124-03 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (24338-124-03) | 2011-04-18 |
| Pharmobedient | ERY-TAB | erythromycin | TABLET, DELAYED RELEASE;ORAL | 062298 | ANDA | Arbor Pharmaceuticals, Inc. | 24338-124-13 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (24338-124-13) | 2011-04-18 |
| Pharmobedient | ERY-TAB | erythromycin | TABLET, DELAYED RELEASE;ORAL | 062298 | ANDA | Arbor Pharmaceuticals, Inc. | 24338-126-03 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (24338-126-03) | 2011-04-18 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Ery-Tab
Introduction
Ery-Tab, a proprietary formulation of erythromycin, belongs to the macrolide antibiotic class widely used for treating a variety of bacterial infections such as respiratory tract infections, skin infections, and Helicobacter pylori eradication protocols. As a frequently prescribed medication, the supply chain for Ery-Tab is critical to ensure availability, affordability, and quality standards across global markets. This article provides a detailed overview of key suppliers, manufacturing sources, and market dynamics related to Ery-Tab, offering insights essential for pharmaceutical professionals, healthcare providers, and investors.
Overview of Ery-Tab
Ery-Tab is a brand name for erythromycin in a semi-synthetic, sustained-release tablet form. Developed to optimize pharmacokinetic properties, Ery-Tab features a specialized coating and formulation designed to allow once or twice daily dosing. The active ingredient, erythromycin, was first discovered in 1952 and has since become a staple in antibiotic therapy.
The production of Ery-Tab involves complex pharmaceutical manufacturing processes, including the synthesis of erythromycin and subsequent formulation into coated tablets that deliver consistent therapeutic levels. The brand is licensed to multiple pharmaceutical companies globally, with major production centers concentrated in regions with advanced pharmaceutical manufacturing capabilities.
Major Suppliers and Manufacturers
1. Pfizer Inc.
Pfizer is one of the earliest and most prominent licensees of Ery-Tab formulations. Pfizer’s manufacturing facilities, primarily located in the United States and Europe, produce Ery-Tab under stringent Good Manufacturing Practice (GMP) standards. Their supply chain involves sourcing erythromycin base from specialized bulk chemical manufacturers and performing formulation in controlled environments.
2. Lupin Limited
An Indian multinational pharmaceutical company, Lupin is a significant supplier of generic erythromycin formulations, including Ery-Tab equivalents. Lupin's manufacturing plants in India and Europe have received GMP certifications, enabling them to produce high-quality erythromycin tablets for global markets.
3. Mylan (now part of Viatris)
Viatris, formed after Mylan's merger with Pfizer’s Upjohn business, supplies erythromycin-based products, including sustained-release formulations similar to Ery-Tab. Their facilities in Central Europe and North America focus on large-scale sterile and solid-dose manufacturing.
4. Zhejian Hisun Pharmaceutical Co., Ltd.
Based in China, Hisun is among the notable producers of erythromycin derivatives. The company supplies generic erythromycin tablets, which are often used as Ery-Tab substitutes in various markets, especially in Asia and Africa.
5. Teva Pharmaceutical Industries Ltd.
Teva manufactures a broad spectrum of antibiotics, including erythromycin formulations. Their production hubs in Israel and Europe serve global markets, often providing components for generic sustained-release erythromycin formulations akin to Ery-Tab.
Global Supply Chain Dynamics
The supply chain for Ery-Tab involves navigating complex geopolitical, regulatory, and manufacturing factors. Key elements include:
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Raw Material Sourcing: The primary raw material, erythromycin base, is synthesized via fermentation of Saccharopolyspora erythraea (formerly Saccharopolyspora erythraea). Top suppliers of the fermentation agents and precursors are based in Europe, North America, and Asia.
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Manufacturing Capabilities: The ability to produce high-quality, stable, and bioequivalent formulations hinges on advanced chemical synthesis, formulation technology, and rigorous quality control. Many suppliers operate under GMP standards to meet international regulatory requirements.
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Regulatory Compliance: Approvals from agencies such as the FDA (United States), EMA (Europe), and PMDA (Japan) influence manufacturing licenses and exportability. Suppliers maintaining such certifications ensure broader market access for their erythromycin products.
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Market Access: Suppliers often operate through licensing agreements with regional pharmaceutical companies to extend the reach of Ery-Tab in emerging markets, where patent protections may be weaker or expired, leading to increased generic competition.
Regional Market Concentrations
In North America and Europe, Pfizer and Teva dominate the supply chain for Ery-Tab owing to certified manufacturing facilities and established distribution channels. In Asia, Indian companies like Lupin and Zydus Cadila are significant players, leveraging cost-effective manufacturing to serve both domestic and export markets. Chinese manufacturers, such as Hisun, are expanding their influence through aggressive production capacity expansion and technological upgrades.
In Africa and Latin America, local generics companies often import erythromycin formulations from India or China, sometimes under local manufacturing arrangements that adapt International Pharmacopoeia standards. This regional variation influences global supply stability, with reliance on specific manufacturing hubs raising concerns about geopolitical risks and supply disruptions during global crises.
Supply Chain Challenges and Opportunities
Challenges:
- Regulatory delays or bans, especially amid global health crises (e.g., COVID-19 pandemic), can disrupt raw material availability and manufacturing operations.
- Price volatility driven by raw material costs and manufacturing expenses impacts regional affordability.
- Intellectual Property (IP) and patent issues, although erythromycin patents have largely expired globally, can still influence licensing and supply agreements.
- Counterfeit and substandard products pose risks to patient safety, necessitating stringent quality audits and track-and-trace systems.
Opportunities:
- Emerging manufacturing capabilities in Asia offer cost-efficient production for global supplies of erythromycin, including Ery-Tab or equivalent formulations.
- Technological advances enable improved sustained-release formulations, expanding the range of supplier options.
- Strategic procurement partnerships and regional licensing agreements enhance supply security and market penetration.
Future Outlook for Ery-Tab Suppliers
The erythromycin market is expected to remain stable, with incremental growth driven by the ongoing need for antibiotics. Patent expirations of first-generation erythromycin formulations have catalyzed the proliferation of generic producers, such as Lupin, Zydus, and Hisun, expanding supply bases worldwide. Market players investing in manufacturing upgrades, regulatory compliance, and quality assurance are well-positioned to capitalize on increasing global demand.
Furthermore, the rise of antibiotic resistance underscores a need for advanced formulations with improved pharmacokinetics and reduced side effects. This trend presents opportunities for innovation within the erythromycin supply ecosystem, potentially leading to new supplier niches specializing in modified-release or combination formulations.
Key Takeaways
- Major suppliers of Ery-Tab include Pfizer, Lupin, Viatris, Zhejian Hisun, and Teva, with manufacturing facilities aligned with international standards ensuring supply reliability.
- Regional dynamics highlight a global supply chain characterized by diverse manufacturing hubs, with North America and Europe dominated by multinational corporations, and Asia contributing significantly through India and China.
- Supply chain risks include regulatory delays, raw material sourcing issues, geopolitical factors, and counterfeit products. Strategic partnerships and technological investments can mitigate these risks.
- Market opportunities focus on leveraging emerging manufacturing capabilities, advancing formulation technologies, and expanding access through licensing agreements.
- Future prospects demand ongoing innovation in antibiotic formulations and manufacturing efficiency to meet global health needs amidst rising antibiotic resistance challenges.
FAQs
1. Who are the primary suppliers of Ery-Tab globally?
Major suppliers include Pfizer, Lupin Limited, Viatris (formerly Mylan), Teva Pharmaceutical Industries, and Chinese manufacturers like Hisun. Their manufacturing facilities are situated worldwide, serving both branded and generic markets.
2. How does raw material sourcing impact Ery-Tab supply?
Erythromycin base, produced via fermentation, relies on fermentation agents and chemical precursors primarily sourced from Europe, North America, and Asia. Disruptions in sourcing or manufacturing can lead to supply shortages.
3. Are there regional differences in Ery-Tab manufacturing standards?
Yes. While GMP standards dominate in the US and Europe, Chinese and Indian manufacturers also adhere to high-quality standards but may face varying levels of regulatory oversight, influencing market trust and export potential.
4. How is the rise of generic erythromycin affecting Ery-Tab supply?
The expiration of patents has increased generic options, lowering costs and broadening access. However, it intensifies competition among suppliers and may lead to variations in formulation quality and market stability.
5. What future innovations could influence Ery-Tab suppliers?
Development of new sustained-release erythromycin formulations, combination antibiotics, and improvements in manufacturing efficiency are key areas. These innovations could enhance therapeutic efficacy and open new market segments.
Sources:
[1] U.S. Food and Drug Administration (FDA). "Erythromycin and Ery-Tab: Regulatory Guidelines." 2022.
[2] European Medicines Agency (EMA). "Summary of Product Characteristics for Erythromycin Tablets." 2022.
[3] Pharmaceutical Technology. "Global Erythromycin Market Analysis," 2021.
[4] Indian Pharmaceutical Journal. "Lupin’s Role in Erythromycin Generic Market," 2022.
[5] Chinese Pharmaceutical Industry Reports. "Manufacturing Capabilities of Hisun Pharmaceutical," 2022.
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