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Suppliers and packagers for CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%
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CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Hikma | CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% | clindamycin phosphate | INJECTABLE;INJECTION | 214401 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9267-01 | 1 VIAL in 1 CARTON (0143-9267-01) / 50 mL in 1 VIAL | 2024-06-12 |
| Hikma | CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% | clindamycin phosphate | INJECTABLE;INJECTION | 214401 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9268-01 | 1 VIAL in 1 CARTON (0143-9268-01) / 50 mL in 1 VIAL | 2024-06-12 |
| Hikma | CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% | clindamycin phosphate | INJECTABLE;INJECTION | 214401 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9269-01 | 1 VIAL in 1 CARTON (0143-9269-01) / 50 mL in 1 VIAL | 2024-06-12 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Clindamycin Phosphate in Dextrose 5%
Introduction
The pharmaceutical landscape for intravenous (IV) antibiotics incorporates various formulations designed to optimize patient outcomes, safety, and logistical efficiency. Clindamycin phosphate in dextrose 5% (D5%) is a widely used IV antibiotic, especially in hospital settings for bacterial infections resistant to other therapies. Identifying reliable suppliers for this formulation is critical for healthcare providers, procurement organizations, and regulatory bodies aiming to ensure drug availability, quality, and compliance with international standards.
Market Overview
Clindamycin phosphate in Dextrose 5% is classified as a sterile, injectable solution primarily indicated for serious bacterial infections. Its formulation in D5% makes it suitable for patients requiring parenteral therapy who cannot take oral medication. The manufacturing and supply of this formulation are governed by strict pharmacopeial standards, including USP, EP, and JP, ensuring safety and efficacy.
Several global pharmaceutical companies and regional manufacturers produce and distribute this formulation. These suppliers must adhere to stringent Good Manufacturing Practices (GMP), possess robust quality assurance measures, and sustain global supply chains to meet demand.
Major Suppliers of Clindamycin Phosphate in Dextrose 5%
1. Pfizer Inc.
Overview:
Pfizer is a leading global pharmaceutical company with a comprehensive portfolio that includes injectable antibiotics. The company's clindamycin phosphate solutions are produced with adherence to international standards, ensuring high purity and stability.
Product Availability:
Pfizer markets clindamycin phosphate in Dextrose 5% formulations through its global distribution network, primarily targeting hospitals and clinics worldwide. The company's manufacturing plants in the U.S., Europe, and Asia support large-scale supply.
Quality & Compliance:
Pfizer's products conform to cGMP guidelines, with extensive clinical and safety data to support regulatory approvals across numerous jurisdictions.
2. Hikma Pharmaceuticals
Overview:
Hikma Pharmaceuticals, headquartered in the UK, operates as a prominent generic injectable manufacturer. The company offers a generic version of clindamycin phosphate in D5% solutions, emphasizing affordability and high-quality standards.
Product Portfolio:
Hikma's formulations are available in multiple regions—including the Middle East, Europe, and North America—delivering consistent quality in accordance with regional pharmacopeial requirements.
Manufacturing and Certification:
Hikma maintains multiple GMP-certified facilities, with certifications from agencies such as EMA and the FDA.
3. Sagent Pharmaceuticals (now part of Hikma)
Overview:
Prior to acquisition by Hikma, Sagent specialized in sterile injectable products, including clindamycin phosphate in Dextrose 5%. Their focus on niche products and high-quality manufacturing positions them as a key supplier.
Product Focus:
Sagent's formulations are characterized by rigorous quality controls, with a focus on hospital and infusion center markets.
Availability:
Discussions with distributors and procurement channels indicate ongoing supply consistent with regional demand.
4. Sun Pharmaceutical Industries Ltd.
Overview:
An Indian multinational, Sun Pharma produces a broad portfolio of generic injectables, including clindamycin phosphate solutions.
Regional Reach:
Mainly serving Asian markets and expanding globally, Sun Pharma's quality commitments comply with WHO, USFDA, and other regulatory standards.
Manufacturing Capabilities:
Their sterile manufacturing units are certified under global standards, ensuring product consistency.
5. Teva Pharmaceuticals
Overview:
As one of the world’s largest generic pharmaceutical companies, Teva supplies clindamycin phosphate IV formulations, including Dextrose 5%, especially across North America and Europe.
Supply Chain and Certifications:
Teva's manufacturing facilities are accredited by multiple regulators, positioning them as a reliable provider capable of large-volume distribution.
Regional and Specialty Suppliers
In addition to multinational pharma giants, regional manufacturers and compounding pharmacies may supply clindamycin phosphate in Dextrose 5% formulations, often tailored to specific institutional needs. These suppliers may operate under regional GMP standards and are subject to local regulatory oversight, which can influence compliance and product quality.
Note: Many hospitals and clinics rely on contracted compounding pharmacies for customized formulations where commercial availability is limited.
Supply Challenges and Considerations
- Regulatory Approvals: Suppliers must meet stringent regulatory requirements—FDA, EMA, WHO—to distribute internationally.
- Manufacturing Capacity: Increased demand in pandemic or outbreak scenarios may strain supply, prompting reliance on multiple suppliers.
- Quality Assurance: Ensuring consistent sterility, stability, and absence of particulates remains paramount.
- Pricing and Procurement Logistics: Globally, pricing varies based on manufacturing location, certification, and distribution agreements.
Conclusion
The supply landscape for clindamycin phosphate in dextrose 5% is characterized by several reputable global manufacturers, including Pfizer, Hikma, Sun Pharma, and Teva. These companies uphold rigorous quality and compliance standards, ensuring a reliable supply chain for healthcare providers. Procurement professionals must consider regional availability, regulatory status, and hospital-specific requirements when selecting suppliers to maintain continuous, high-quality patient care.
Key Takeaways
- Major global suppliers of clindamycin phosphate in Dextrose 5% include Pfizer, Hikma Pharmaceuticals, Sun Pharma, and Teva, among others.
- Supplier selection should prioritize regulatory compliance, manufacturing quality, and regional distribution capabilities.
- Supply chain robustness is vital, especially amid global disruptions; diversified sourcing mitigates risk.
- Regional and compounding pharmacies can serve niche or urgent needs but require strict quality oversight.
- Staying updated on regulatory changes and manufacturing capacities ensures uninterrupted access to this critical medication.
Frequently Asked Questions (FAQs)
1. Is clindamycin phosphate in Dextrose 5% available in generic forms?
Yes, multiple generic manufacturers like Hikma, Sun Pharma, and Teva produce generic versions, offering cost-effective alternatives to brand-name products.
2. What standards do suppliers of clindamycin phosphate in Dextrose 5% need to meet?
Suppliers must comply with Good Manufacturing Practices (GMP) and obtain certification from regulatory agencies such as the USFDA, EMA, or WHO to ensure product safety and efficacy.
3. Are there regional differences in the formulation of clindamycin phosphate in Dextrose 5%?
Yes, formulations may vary slightly based on regional regulatory requirements, but core standards for sterility, stability, and safety are maintained globally.
4. How can healthcare providers verify the legitimacy of a supplier?
Providers should verify supplier accreditation, certifications (GMP, ISO), and regulatory approvals through official channels and supplier documentation.
5. What are the potential supply chain disruptions for this medication?
Disruptions can result from manufacturing halts, regulatory issues, import/export restrictions, pandemics, or raw material shortages. Diversified sourcing reduces vulnerability.
References
- United States Pharmacopeia (USP). Clindamycin phosphate injections. USP monograph.
- European Pharmacopoeia (EP). Clindamycin phosphate specifications.
- Hikma Pharmaceuticals. Product datasheets and certifications.
- FDA. Approved Drug Applications for clindamycin formulations.
- WHO. Guidelines for sterile injectable manufacture.
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