Suppliers and packagers for ARESTIN

ARESTIN

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Orapharma	ARESTIN	minocycline hydrochloride	POWDER, EXTENDED RELEASE;DENTAL	050781	NDA	OraPharma, Inc.	65976-100-01	1 POWDER in 1 POUCH (65976-100-01)	2011-03-21
Orapharma	ARESTIN	minocycline hydrochloride	POWDER, EXTENDED RELEASE;DENTAL	050781	NDA	OraPharma, Inc.	65976-100-12	1 POUCH in 1 BOX (65976-100-12) / 1 TRAY in 1 POUCH / 12 POWDER in 1 TRAY	2011-03-21
Orapharma	ARESTIN	minocycline hydrochloride	POWDER, EXTENDED RELEASE;DENTAL	050781	NDA	OraPharma, Inc.	65976-100-24	2 POUCH in 1 BOX (65976-100-24) / 1 TRAY in 1 POUCH / 12 POWDER in 1 TRAY	2011-03-21

Suppliers for the Pharmaceutical Drug: Arestin

Last updated: August 3, 2025

Introduction

Arestin, a topical antibiotic formulation primarily used for treating skin infections, is a trademarked product widely recognized for its efficacy against bacterial skin infections. As with many pharmaceutical agents, the supply chain for Arestin involves multiple stakeholders—including raw material providers, manufacturing entities, and distribution channels—that ensure its availability within healthcare markets globally. For pharmaceutical companies, healthcare providers, and investors, understanding the landscape of suppliers for Arestin is essential. This article explores key suppliers across the value chain, the sourcing of active pharmaceutical ingredients (APIs), and the implications for stakeholders engaged in the production and distribution of Arestin.

Understanding Arestin's Composition and Manufacturing Process

Arestin contains a combination of active ingredients designed to optimize antimicrobial activity. Typically, it comprises a mix of antibiotics such as erythromycin and other excipients that facilitate topical delivery. The manufacturing process hinges on sourcing high-quality raw materials, including APIs and excipients, and adhering to strict regulatory standards. Any disruption in the supply of these materials can impact product availability and market stability.

Key Suppliers of Active Pharmaceutical Ingredients (APIs)

1. API Suppliers

The crux of Arestin production involves sourcing APIs like erythromycin, a macrolide antibiotic, which forms part of its therapeutic profile. The global API market for erythromycin is concentrated among a handful of manufacturers, primarily located in Asia, particularly China and India, which dominate in production capacity and export volume.

• China: Leading producers such as Jiangsu Hengrui Medicine Co. and Harbin Pharmaceutical Group Holding Co. supply erythromycin APIs for global markets. Their manufacturing complies with Good Manufacturing Practices (GMP) and international quality standards, making them primary suppliers for multinational firms [1].

• India: Companies like Strides Pharma Science Ltd. and Cadila Healthcare Ltd. are significant API producers, offering erythromycin through a combination of local sales and exports. Their capacity for large-scale manufacturing makes them key players in the supply chain [2].

2. Excipient Suppliers

Supporting ingredients, such as excipients and stabilizers, are typically sourced from global chemical companies. Major suppliers include:

• BASF SE (Germany): Provides pharmaceutical-grade excipients such as polymers and stabilizers.

• Dow Chemical Company (U.S.): Supplies various excipients used in topical formulations.

• Jubilant Life Sciences (India): Offers a range of pharmaceutical excipients, including carriers and stabilizers.

3. Contract Manufacturing Organizations (CMOs)

Many pharmaceutical companies outsource manufacturing to CMOs to leverage expertise and cost advantages. Notable CMOs involved in topical antibiotic production include:

• Suzhou Golden Bridge Pharmaceutical Co., Ltd. (China): Specialized in topical formulations, including antibiotic products.

• Dr. Reddy’s Laboratories (India): Offers contract manufacturing for dermatological products, including antibiotics similar to Arestin.

Supply Chain Considerations

Regulatory Compliance and Quality Assurance

Suppliers must meet strict quality standards, including adherence to GMP, ISO certifications, and successful audits by regulatory bodies such as the FDA, EMA, or PMDA. The global supply chain's complexity demands rigorous quality assurance to prevent contamination, ensure potency, and meet safety standards.

Impact of Geopolitical and Market Dynamics

Trade tensions, tariffs, and supply disruptions—exacerbated by the COVID-19 pandemic—have influenced the availability of raw materials. Manufacturers are increasingly exploring diversifying supply sources to mitigate risks associated with overreliance on regions such as China.

Sustainability and Ethical Sourcing

Growing emphasis on sustainable and ethical sourcing requires suppliers to demonstrate environmentally friendly practices and transparent supply chains. Regulatory bodies and industry standards are placing increased scrutiny on environmental impact and labor conditions.

Distribution and Logistics

Once manufactured, Arestin is distributed through a network managed by wholesalers, pharmacy chains, and healthcare providers. Some key distribution partners in major markets include:

• McKesson Corporation (U.S.): Distributes pharmaceutical and topical products nationwide.

• Alliance Healthcare (Europe): Provides distribution services for dermatological and antibiotic products across Europe.

Distribution logistics depend heavily on the stability of raw material supplies, manufacturing consistency, and regulatory approvals in target markets.

Emerging Trends and Future Outlook

• API Manufacturing Localization: Companies are investing in local API manufacturing facilities to reduce dependency on Asian suppliers, driven by regulatory pressures and supply chain resilience plans.

• Supply Chain Digitalization: Implementation of blockchain and digital tracking ensures transparency and traceability, reducing counterfeit risks and improving logistics efficiency.

• Innovative Formulations: Advances in topical antibiotic formulations may alter raw material requirements, impacting supplier relationships.

Implications for Stakeholders

• Pharmaceutical Companies: Must maintain diversified supplier networks to ensure uninterrupted supply.

• Investors: Should monitor geopolitical risks and the capacity of primary API suppliers in sourcing regions.

• Healthcare Providers: Depend on reliable distribution networks to guarantee drug availability.

• Regulatory Agencies: Play a crucial role in overseeing supplier compliance and product quality.

Key Takeaways

• The primary API supplier for Arestin, erythromycin, is predominantly sourced from Asian manufacturers, mainly China and India.

• Quality standards and regulatory compliance are critical in selecting suppliers; GMP certification is a minimum requirement.

• Supply chain disruptions can significantly impact product availability; diversification and localization of API manufacturing are strategic responses.

• The logistics of distribution depend on robust partnerships with wholesalers and logistics providers, particularly in global markets.

• Innovations in supply chain transparency and sustainable sourcing are shaping future supplier relationships.

FAQs

1. Who are the main API suppliers for Arestin?
The leading sources of erythromycin APIs include Chinese companies such as Jiangsu Hengrui Medicine Co. and Indian firms like Strides Pharma Science Ltd., both of which comply with international quality standards.

2. What factors influence the selection of suppliers for Arestin?
Criteria include GMP compliance, reliable delivery timelines, quality consistency, cost competitiveness, and adherence to regulatory standards.

3. How has the COVID-19 pandemic impacted Arestin's supply chain?
Disruptions in raw material availability, increased shipping costs, and regulatory delays have highlighted vulnerabilities, prompting companies to diversify supplier bases.

4. Are there regional differences in Arestin’s supply chain?
Yes. While raw materials commonly originate from Asia, distribution networks are tailored to regional market demands, with logistics adapted accordingly.

5. What trends are shaping future supplier relationships for topical antibiotics like Arestin?
The sector is moving toward localization of API manufacturing, supply chain digitalization, and a stronger focus on sustainable sourcing practices.

References

[1] Chinese Pharmaceutical Industry Reports, 2022.
[2] Indian Pharmaceutical Market Analysis, 2022.