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Suppliers and packagers for LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
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LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Hospira | LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | linezolid | SOLUTION;INTRAVENOUS | 206473 | NDA | Hospira, Inc. | 0409-4883-01 | 10 POUCH in 1 CASE (0409-4883-01) / 1 BAG in 1 POUCH / 300 mL in 1 BAG (0409-4883-11) | 2015-06-18 |
| Hospira | LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | linezolid | SOLUTION;INTRAVENOUS | 206473 | NDA | Hospira, Inc. | 0409-4883-10 | 10 POUCH in 1 CASE (0409-4883-10) / 1 BAG in 1 POUCH / 300 mL in 1 BAG (0409-4883-03) | 2015-06-18 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Linezolid in Sodium Chloride 0.9% in Plastic Container
Overview of Linezolid in 0.9% Sodium Chloride Solution
Linezolid, an oxazolidinone antibiotic, is widely used for treating serious bacterial infections, including pneumonia, skin, and soft tissue infections. The formulation of linezolid in sodium chloride 0.9% offers compatibility for intravenous administration, ensuring stability and ease of infusion. Manufacturers and suppliers of this specific formulation primarily operate within the pharmaceutical supply chain, adhering to stringent quality and regulatory standards.
This article catalogs leading suppliers for linezolid in sodium chloride 0.9% in plastic containers, focusing on global pharmaceutical companies, contract manufacturing organizations, and authorized distributors known for supplying high-quality injectable formulations.
Global Suppliers of Linezolid in Sodium Chloride 0.9% in Plastic Containers
1. Pfizer Inc.
Overview: Pfizer developed and marketed the original brand, Zyvox, which contains linezolid. The company manufactures both the active pharmaceutical ingredient (API) and the finished drug product.
Supply Scope: Pfizer supplies linezolid in IV formulations, including sodium chloride 0.9% solutions in sterile plastic containers, primarily for the North American and European markets.
Quality Standards: GMP-compliant manufacturing with ISO certifications and rigorous quality assurance protocols.
Distribution Network: Extensive global distribution network ensures availability in multiple regions, including Asia, Europe, and the Americas.
2. Sandoz (Novartis) Pharmaceutical Division
Overview: Sandoz manufactures a range of biosimilars and generic injectable antibiotics, including linezolid in sodium chloride solutions.
Supply Scope: Offers stable, ready-to-use IV linezolid products in plastic containers, supplied primarily to hospitals and controlled distribution channels worldwide.
Quality Assurance: Follows rigorous GMP standards aligned with European Medicines Agency (EMA) and FDA regulations.
Market Reach: Strong presence across Europe, Latin America, and Asia.
3. Teva Pharmaceutical Industries Ltd.
Overview: Teva manufactures generic versions of linezolid, often including injectable solutions in sodium chloride 0.9%.
Supply Scope: Supplies sterile, prefilled plastic container formulations, predominantly for global markets including North America, Middle East, and Africa.
Compliance: Certified by regulatory bodies including the FDA and EMA with robust quality management systems.
Logistics: Known for reliable supply chain management supporting hospital procurement and distribution.
4. Hospira (A Pfizer Company prior to acquisition)
Overview: Hospira specializes in sterile injectables and is a significant manufacturer of linezolid formulations.
Supply Scope: Provides prefilled or bulk linezolid in sodium chloride 0.9% solutions, predominantly in plastic containers for hospital use.
Quality & Certification: Emphasizes adherence to cGMP, with certifications from global regulators.
Distribution: Extensive international reach serving hospital systems and wholesalers worldwide.
5. Dr. Reddy’s Laboratories
Overview: Indian pharmaceutical manufacturer with a broad portfolio of injectable antibiotics, including linezolid.
Supply Scope: Supplies linezolid IV solutions in sodium chloride 0.9% in plastic containers, mainly targeting South Asia, Southeast Asia, and emerging markets.
Standards: Operates GMP-certified manufacturing facilities complying with national and international standards.
Market Focus: Growing presence via partnerships and direct distribution channels.
Contract Manufacturing Organisations (CMOs) and Third-party Suppliers
For pharmaceutical companies seeking to outsource or expand supply capacity, several CMOs provide API manufacturing and formulation services:
1. Recipharm
Specialization: Contract manufacturing of sterile injectables, including linezolid in saline solutions.
Market Focus: Serves global generic and innovative pharmaceutical companies.
2. Fujifilm Toyama Chemical
Role: Known for manufacturing specific antibiotic formulations, including stable IV linezolid products.
3. Aenova
Expertise: Provides fill-finish services for sterile injectables, including linezolid formulations in saline in plastic containers.
4. Boehringer Ingelheim
Capacity: Produces high-quality API and formulation services, ensuring reliable supply of linezolid in IV formulation.
5. Baxter International
Role: Supplies sterile injectable drugs, including stable prefilled linezolid products to hospitals worldwide.
Regional Suppliers and Distributors
In addition to large pharmaceutical firms, numerous regional distributors supply linezolid in saline solutions, often under authorized distribution agreements with manufacturers:
- MediGene (Europe)
- Neopharm Group (Middle East)
- Gland Pharma (India)
- Hetero Labs (India)
- Amneal Pharmaceuticals (North America)
Such distributors often source directly from manufacturers or licensed brokers, ensuring regulatory compliance and supply chain integrity.
Supply Chain Considerations
Regulatory Approval: All suppliers must meet stringent regulatory standards, including FDA, EMA, or local regulatory authority approvals, to ensure product safety, efficacy, and quality.
Manufacturing Certifications: GMP certification, ISO standards, and quality control testing underpin the reliability of supply and product stability.
Pricing & Procurement: Large-scale procurement typically involves negotiated contracts, with considerations given to regional availability, manufacturing capacity, and regulatory status.
Intellectual Property: Linezolid’s patent status varies by region, influencing the dynamics of suppliers—original manufacturers versus generics.
Key Takeaways
- Leading global pharmaceutical companies such as Pfizer, Sandoz, Teva, and Hospira dominate the supply of linezolid in sodium chloride 0.9% in plastic containers, adhering to high manufacturing standards.
- Contract manufacturing organizations like Recipharm and Fujifilm provide scalable solutions for pharmaceutical companies seeking outsourced production.
- Regional distributors offer critical access points in emerging markets, often bridging the gap between global suppliers and local healthcare providers.
- Ensuring regulatory compliance, product quality, and supply chain integrity is essential when sourcing linezolid formulations for hospital or pharmaceutical use.
- Strategic procurement should prioritize verified GMP-certified manufacturers and authorized distributors to mitigate risks associated with counterfeit or substandard products.
FAQs
1. Who are the primary global suppliers of linezolid in saline solution?
Pfizer (Zyvox), Sandoz (Novartis), Teva, Hospira, and Dr. Reddy’s are primary suppliers, offering formulations in plastic containers suitable for IV administration.
2. Can I source linezolid in sodium chloride 0.9% directly from contract manufacturers?
Yes, contract manufacturers like Recipharm and Fujifilm can produce such formulations under contract, provided due diligence on regulatory compliance and quality standards.
3. Are there regional differences in suppliers for this formulation?
Yes, regional suppliers vary based on patent status, manufacturing capacity, and regulatory approvals, with Asian manufacturers like Dr. Reddy’s and Gland Pharma playing significant roles in emerging markets.
4. What quality standards should I verify before sourcing?
Ensure GMP certification, ISO standards, and regulatory approvals (FDA, EMA, or local agencies) to guarantee product quality.
5. How can I ensure supply chain security for this drug?
Engage with reputable, GMP-certified suppliers and authorized distributors with proven track records. Implement validated cold chain and inventory management systems to prevent shortages and counterfeit risks.
Sources:
[1] Pfizer Inc., Zyvox Product Monograph.
[2] Novartis Sandoz official product catalog.
[3] Teva Global Product Portfolio.
[4] Hospira (Pfizer) official documentation.
[5] Dr. Reddy’s Laboratories product information.
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