Suppliers and packagers for primaxin

primaxin

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Merck	PRIMAXIN	cilastatin sodium; imipenem	POWDER;INTRAVENOUS	050587	NDA	Merck Sharp & Dohme LLC	0006-3516-59	25 VIAL, SINGLE-DOSE in 1 TRAY (0006-3516-59) / 100 mL in 1 VIAL, SINGLE-DOSE	1985-11-26

Suppliers for the Pharmaceutical Drug: Primaxin

Last updated: July 29, 2025

Introduction

Primaxin, the commercial name for the combination drug imipenem and cilastatin, is an injectable carbapenem antibiotic used extensively for treating severe bacterial infections, including hospital-acquired pneumonia, complicated intra-abdominal infections, and urinary tract infections. Its efficacy stems from imipenem’s broad-spectrum bactericidal activity, while cilastatin inhibits renal dehydropeptidase I, preventing imipenem's rapid degradation in the kidneys. Given its clinical importance, understanding the supply chain for primaxin is vital for healthcare providers, pharmaceutical companies, and stakeholders aiming to ensure consistent drug availability.

Manufacturers of Primaxin

Primaxin is primarily manufactured by Merck & Co., Inc., which develops and distributes the drug globally under the brand name Primaxin. As a leading multinational pharmaceutical company, Merck maintains control over the drug’s formulation, manufacturing standards, and quality assurance protocols, ensuring compliance with international regulatory bodies such as the FDA (United States), EMA (European Union), and other local agencies.

While Merck is the dominant producer, the global demand has prompted development of generic equivalents and biosimilars by other pharmaceutical entities, especially in regions with high infection rates and limited access to branded medications.

Key Suppliers and Producing Entities

1. Merck & Co., Inc.

As the originator and primary supplier, Merck operates manufacturing plants in various locations, including the United States, Europe, and Asia. These facilities adhere to strict Good Manufacturing Practices (GMP) standards mandated by regulatory agencies. Merck supplies primaxin through its global distribution network, partnering with wholesalers, hospital procurement programs, and government tenders.

2. Generic Manufacturers

The expiration of some patent protections has stimulated the entry of generic manufacturers, offering cost-effective alternatives, particularly in developing economies. Notable generic producers include:

• Sandoz (Novartis Group): Produces generic imipenem formulations in multiple markets, including Asia and Europe.
• Mylan (now part of Viatris): Offers generic equivalents of imipenem with cilastatin, supplying numerous countries.
• Pharmascience: A Canadian firm manufacturing generic imipenem products.
• Hikma Pharmaceuticals: Provides generic carbapenems to various global markets.

These entities often manufacture APIs (Active Pharmaceutical Ingredients) and finished dosage forms, subject to regulatory approvals and quality requirements.

3. API Suppliers

The core of primaxin's production is the supply of imipenem and cilastatin APIs. The primary API manufacturers include:

• Novartis (Sandoz): Produces high-quality imipenem APIs for both proprietary and generic formulations.
• Aspen Pharmacare: Supplies APIs with validated manufacturing processes.
• Uni-Bio Science: A South Korean biotech firm that produces APIs for antimicrobial agents.
• FAPI (Foreign API) Providers: Several firms in China and India are major API producers, exporting to both branded and generic drug manufacturers worldwide.

The API market is highly competitive, with manufacturing concentrated in countries with established pharmaceutical industries, notably India, China, and Switzerland.

Regulatory and Supply Chain Considerations

Global supply chains for primaxin and its APIs depend heavily on strict regulatory standards, raw material availability, and geopolitical stability. Disruptions in any link can impact drug availability. The COVID-19 pandemic exposed vulnerabilities, prompting diversification of production sources and increased stockpiles.

Certifications such as FDA Drug Master Files (DMFs) and EMA Common Technical Documents (CTDs) validate manufacturing quality and facilitate regulatory approvals. Manufacturers must maintain transparency and compliance with GMP to sustain supply relationships with healthcare providers and government agencies.

Market Dynamics and Trends

The growth of generic APIs and formulations signifies increased competition, driving down prices while expanding access globally. However, patent exclusivity periods and regulatory hurdles often influence market entry timelines. Merck maintains a competitive edge through continuous innovation, proprietary manufacturing processes, and strong marketing channels.

In regions where patent protection has lapsed, local manufacturers, particularly in India and China, have become primary suppliers of primaxin generics. These markets often rely on imported APIs that meet international standards, reinforcing the importance of robust API supply chains.

Challenges in Supply Chain Management

• Regulatory Approval: Ensuring generic products meet quality standards often involves lengthy approval processes, impacting timely availability.
• Raw Material Access: Political or trade disputes can hamper the procurement of raw materials, especially in regions heavily reliant on specific countries for APIs.
• Manufacturing Capacity: Capacity constraints could lead to shortages during surges in demand, such as during pandemic outbreaks or multi-drug resistant infection spikes.
• Quality Assurance: Stringent quality controls are essential to prevent substandard or falsified drugs entering the supply chain, a persistent concern globally.

Future Outlook

Advancements in biotechnological processes, such as enzyme synthesis for APIs, are expected to enhance manufacturing efficiency and reduce costs. Efforts to establish local API production facilities in emerging markets aim to mitigate supply chain vulnerabilities. Additionally, increasing regulations around antimicrobial stewardship emphasize the need for reliable, high-quality suppliers to combat antibiotic resistance.

Collaborations between multinational companies and regional manufacturers will likely intensify, facilitating the expansion of primaxin access worldwide. Strategic stockpiling and diversified sourcing are predicted to become standard practices for healthcare systems aiming to ensure uninterrupted supplies.

Key Takeaways

• Merck remains the principal manufacturer of primaxin, with global distribution rights and quality assurance oversight.
• Increased production of generic equivalents by companies like Sandoz, Mylan, and Hikma has broadened supply options.
• The APIs for imipenem and cilastatin are manufactured primarily in India, China, Switzerland, and South Korea, with multiple registered API suppliers.
• Regulatory compliance, raw material security, and manufacturing capacity are critical factors influencing supply chain stability.
• The growing global emphasis on antimicrobial stewardship and supply diversification will shape future supplier landscapes.

FAQs

1. Who currently manufactures primaxin?
   Primaxin is primarily produced by Merck & Co., with generic formulations supplied by several regional manufacturers including Sandoz, Mylan, and Pharmascience.

2. Where are primaxin APIs primarily sourced from?
   APIs are mainly sourced from India, China, Switzerland, and South Korea, where major pharmaceutical and biotech firms manufacture high-quality active ingredients.

3. Are generic primaxin products as reliable as branded versions?
   Yes, provided they meet regulatory standards such as FDA or EMA approvals, generic primaxin formulations are equivalent in safety, efficacy, and quality.

4. What are the main challenges in the supply chain for primaxin?
   Challenges include regulatory approval processes, raw material shortages, manufacturing capacity constraints, and geopolitical disruptions affecting trade.

5. How might future developments impact primaxin supply?
   Advances in API manufacturing technology, regional production initiatives, and diversification strategies aim to strengthen the global supply chain amidst rising antimicrobial resistance and regulatory pressures.

References

[1] U.S. Food and Drug Administration. Drug Master Files (DMFs).
[2] European Medicines Agency. Regulatory Requirements for Generic Medicines.
[3] GlobalData. Antimicrobial Market Report.
[4] Indian Pharmaceutical Alliance. API Production and Supply Chain Dynamics.
[5] Merck & Co. Official Website and Product Information.