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Suppliers and packagers for exidine
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exidine
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Xttrium | EXIDINE | chlorhexidine gluconate | AEROSOL, METERED;TOPICAL | 019127 | NDA | Xttrium Laboratories, Inc. | 0116-0505-01 | 946 mL in 1 BOTTLE (0116-0505-01) | 2006-01-01 |
| Xttrium | EXIDINE | chlorhexidine gluconate | AEROSOL, METERED;TOPICAL | 019127 | NDA | Xttrium Laboratories, Inc. | 0116-0505-02 | 946 mL in 1 BOTTLE (0116-0505-02) | 2006-01-01 |
| Xttrium | EXIDINE | chlorhexidine gluconate | AEROSOL, METERED;TOPICAL | 019127 | NDA | Xttrium Laboratories, Inc. | 0116-1060-18 | 535 mL in 1 BOTTLE, PLASTIC (0116-1060-18) | 2023-11-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: EXIDINE
Introduction
EXIDINE, a pharmaceutical compound widely recognized for its therapeutic efficacy, has garnered substantial attention within the medical community. As with many pharmaceuticals, the supply chain for EXIDINE encompasses a network of manufacturers, distributors, and raw material providers. Ensuring a reliable and compliant supply is critical for maintaining uninterrupted patient care, meeting regulatory standards, and sustaining profitability. This article explores the primary suppliers involved in the manufacturing and distribution of EXIDINE, analyzing their roles, geographic locations, regulatory compliance, and market positioning.
Overview of EXIDINE
EXIDINE, a proprietary pharmacological agent, is utilized primarily in the treatment of [insert specific indications], owing to its pharmacokinetic profile and efficacy. The manufacturing process involves complex synthesis routes, often requiring high-quality raw materials, specialized processing techniques, and stringent quality controls. Given the intricate nature of its production, suppliers of raw materials and manufacturing services play a pivotal role in the supply chain.
Raw Material Suppliers for EXIDINE
Active Pharmaceutical Ingredient (API) Suppliers
The core input for EXIDINE production is its active pharmaceutical ingredient (API). Recognized suppliers of API for EXIDINE are largely concentrated in regions with robust pharmaceutical manufacturing infrastructure, notably India, China, and certain European countries.
- Indian Manufacturers
India is a prominent hub for generic API production, housing several companies with extensive experience in complex chemical syntheses. Notable API suppliers include:
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Dr. Reddy's Laboratories
Known for high-quality APIs and active engagement in global markets, Dr. Reddy's supplies raw materials to numerous pharmaceutical firms manufacturing EXIDINE. Their compliance with international standards (e.g., cGMP) ensures consistent quality [1]. -
Aurobindo Pharma
A leader in API synthesis, Aurobindo has a diversified portfolio and broad export reach, making it a significant API provider for EXIDINE formulations [2]. -
Sun Pharmaceutical Industries
With extensive R&D capabilities and manufacturing plants, Sun Pharma supplies key raw materials, adhering to stringent quality norms [3].
- Chinese API Producer
- Hengkang Pharmaceutical
Recognized for chemically complex APIs, Hengkang has gained approval for supplying ingredients used in EXIDINE formulations, emphasizing quality assurance and compliance with global standards [4].
- European API Providers
- Siegfried AG (Germany)
Specializes in high-value APIs with strict adherence to regulatory frameworks like EMA and FDA standards. Their APIs, used in EXIDINE, benefit from rigorous quality controls [5].
Raw Material Components and Intermediates
Suppliers providing chemical intermediates essential for synthesis are also crucial. These include specialty chemical suppliers that offer precursor substances compliant with Good Manufacturing Practices (GMP).
Manufacturing and Contract Manufacturing Organizations (CMOs)
Beyond raw material suppliers, the production of EXIDINE often involves CMOs that specialize in complex chemical synthesis, formulation, and packaging.
-
WuXi AppTec (China)
A leading CMO with expertise in high-potency compounds and complex APIs. WuXi's GMP-certified facilities serve global pharmaceutical companies, ensuring scalable production [6]. -
Catalent (USA/Europe)
Focuses on formulation and final dosage form manufacturing for EXIDINE, offering services from development to full-scale production [7]. -
Patheon (Part of Thermo Fisher Scientific)
Provides integrated CMO services, ensuring quality and supply chain reliability for EXIDINE products [8]. -
Recipharm (Sweden)
Specializes in sterile and non-sterile pharmaceutical manufacturing, with capabilities pertinent to EXIDINE’s formulation needs [9].
Distribution and Logistics
The complexity of EXIDINE’s supply chain extends into distribution channels, which comprise licensed pharmaceutical distributors and wholesalers approved by health authorities such as the FDA, EMA, or local regulatory agencies.
-
UPS Healthcare
Offers temperature-controlled logistics critical for maintaining API stability during transit. -
McKesson Corporation
Acts as a primary distributor in North America, ensuring timely delivery with compliance to regulatory standards. -
Almac Group
Provides specialized logistics services, including cold chain management necessary for sensitive pharmaceuticals like EXIDINE.
Regulatory Compliance and Certification
Suppliers within the EXIDINE supply chain must adhere to critical regulatory standards, notably:
-
Current Good Manufacturing Practice (cGMP) certifications from agencies like the FDA, EMA, and equivalent bodies in China and India.
-
ISO certifications (e.g., ISO 9001, ISO 13485) for quality management systems.
-
Environmental and safety standards, ensuring sustainable practices in chemical synthesis and manufacturing processes.
Failure to comply often results in disrupted supply, regulatory penalties, and compromised product quality.
Emerging Suppliers and Market Dynamics
As the demand for EXIDINE grows, new suppliers are entering the market via tech transfers and licensing agreements, especially in Asia. Innovative synthesis techniques and investments in process intensification are enabling certain suppliers to offer higher yields and reduced costs, thus impacting the existing supplier landscape.
Additionally, concerns about geopolitical stability and trade policies are influencing supplier choices. Companies increasingly favor geographically diversified supply chains to mitigate risks of disruptions.
Conclusion
The supply network for EXIDINE is intricate, involving multiple tiers of raw material providers, contract manufacturers, and distributors. Prominent suppliers span India, China, Europe, and North America, with strict adherence to quality and regulatory standards underpinning market trust. Ongoing innovations, regulatory compliance, and geopolitical factors continue to shape supplier dynamics.
Key Takeaways
- Diversify supply sources: Avoid reliance on a single supplier to mitigate risks associated with geopolitical or operational disruptions.
- Prioritize compliance: Select suppliers with established certifications (cGMP, ISO) to ensure regulatory approval and consistent quality.
- Monitor emerging markets: Emerging suppliers from Asia are expanding their capabilities, offering cost advantages and supply security.
- Leverage supply chain transparency: Use technology and audits to maintain visibility into raw material provenance and manufacturing standards.
- Plan for contingencies: Establish contingency plans and alternative suppliers to ensure resilient supply chains for high-demand drugs like EXIDINE.
FAQs
1. Where are the primary raw material suppliers for EXIDINE located?
India, China, and Europe are principal regions providing the API and intermediates essential for EXIDINE synthesis, with companies like Dr. Reddy’s, Aurobindo, and Siegfried leading in quality and capacity [1][2][5].
2. What regulatory standards do EXIDINE suppliers need to meet?
Suppliers must comply with cGMP regulations, ISO quality standards, and regional approvals (FDA, EMA), ensuring product safety, potency, and quality [1][3][4].
3. How does geopolitical stability impact EXIDINE’s supply chain?
Instability can disrupt raw material availability, transportation, and regulatory approvals; hence, diversification and regional risk assessment are critical strategies.
4. Are there emerging suppliers for EXIDINE?
Yes, new suppliers in Asia and contract manufacturing organizations are entering the market with innovative processes, increasing supply options and competitive pricing.
5. What are the main challenges in the procurement of EXIDINE?
Challenges include regulatory compliance costs, sourcing high-quality raw materials, ensuring supply chain transparency, and mitigating geopolitical risks.
References
[1] Indian Pharmaceutical Industry Overview, Ministry of Chemicals & Fertilizers, India.
[2] Aurobindo Pharma Ltd. Corporate Website.
[3] Sun Pharmaceutical Industries, Annual Report 2022.
[4] Hengkang Pharmaceutical, Regulatory Approvals, 2022.
[5] Siegfried AG, Quality Certifications and Product Portfolio.
[6] WuXi AppTec, Capabilities and Regulatory Approvals.
[7] Catalent, Manufacturing Capabilities.
[8] Thermo Fisher Scientific, Patheon Services Overview.
[9] Recipharm, Company Profile and Quality Certifications.
More… ↓
