Suppliers and packagers for generic pharmaceutical drug: cilastatin sodium; imipenem; relebactam

cilastatin sodium; imipenem; relebactam

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Msd Merck Co	RECARBRIO	cilastatin sodium; imipenem; relebactam	POWDER;INTRAVENOUS	212819	NDA	Merck Sharp & Dohme LLC	0006-3856-02	25 VIAL, SINGLE-DOSE in 1 CARTON (0006-3856-02) / 20 mL in 1 VIAL, SINGLE-DOSE (0006-3856-01)	2020-01-06

Suppliers for the Pharmaceutical Drugs: Cilastatin Sodium, Imipenem, Relebactam

Last updated: July 27, 2025

Introduction

The pharmaceutical industry depends heavily on reliable suppliers to ensure the timely and consistent availability of active pharmaceutical ingredients (APIs). For critical antibiotic combinations such as cilastatin sodium, imipenem, and relebactam, the choice of suppliers influences manufacturing quality, regulatory compliance, and market competitiveness. This article provides a comprehensive overview of prominent suppliers for these compounds, emphasizing their roles, market presence, and strategic importance.

Overview of the Drugs

• Imipenem: A carbapenem antibiotic effective against a broad spectrum of bacteria, classified as a β-lactam antibiotic. It is often used in combination with cilastatin sodium to inhibit renal dehydropeptidase and prevent degradation.

• Cilastatin Sodium: An inhibitor of renal dehydropeptidase I, administered concomitantly with imipenem to prolong its half-life and effectiveness.

• Relebactam: A novel β-lactamase inhibitor partnered with imipenem in certain formulations to combat resistant bacteria, including carbapenem-resistant Enterobacteriaceae.

Understanding the primary suppliers for these pharmaceuticals is crucial for industry stakeholders to mitigate supply chain risks, ensure regulatory compliance, and optimize procurement strategies.

Major Suppliers of Imipenem and Cilastatin Sodium

1. Biotechnology and Active Pharmaceutical Ingredient (API) Manufacturers

a. Pfizer Inc.

• Pfizer is historically a leading producer of imipenem-relebactam formulations, especially through its acquisition of certain assets and partnerships.
• The company manufactures both the API and finished formulations, with manufacturing facilities in the US, EU, and Asia.
• Their API manufacturing includes facilities compliant with Good Manufacturing Practice (GMP), ensuring high-quality standards.

b. Novartis AG

• Novartis supplies imipenem and cilastatin sodium through its robust API manufacturing operations.
• The company operates production sites in Europe and Asia, with proven expertise in β-lactam antibiotics.
• Novartis's API production is certified under international GMP standards, facilitating global distribution.

c. Lupin Limited

• Indian pharmaceutical company Lupin is a significant supplier of generic imipenem and cilastatin sodium.
• Their API manufacturing plants in India are certified by the WHO and other authorities.
• Lupin's export portfolio includes APIs for multiple global markets, including North America and Europe.

d. Hetero Drugs Ltd.

• Hetero, another Indian API manufacturer, produces imipenem and cilastatin sodium, primarily for the generics market.
• Their facilities adhere to the US FDA and EMA quality standards, boosting their credibility as reliable suppliers.

2. Chinese API Producers

a. Shanghai Highchem Co., Ltd.

• Specializes in the production of β-lactam APIs, including imipenem and cilastatin sodium.
• Offers competitive pricing, making them a popular choice among generics manufacturers targeting Asian and global markets.

b. Jiangsu Hengrui Medicine Co., Ltd.

• Hengrui supplies APIs for various antibiotics, including imipenem and related compounds.
• The company’s manufacturing sites are GMP-certified, with a focus on quality and international compliance.

3. Other Notable Suppliers

• Shandong Luk Pharmaceutical Co., Ltd. and Zhejiang Haizheng Pharmaceutical Co., Ltd. are emerging Chinese manufacturers producing imipenem and cilastatin sodium, expanding the global supplier base.

Relebactam Suppliers

1. Merck & Co., Inc.

• Relebactam was developed by Merck (known as MSD outside the US and Canada).
• Merck is the primary supplier of Relebactam, holding the patent rights and manufacturing facilities dedicated to this compound.
• The drug is marketed under the brand name Recarbrio (imipenem, cilastatin, and relebactam).

2. Contract Manufacturing Organizations (CMOs)

• Several CMOs collaborate with Merck to produce relebactam, ensuring supply chain robustness.
• These include specialized biotech firms with expertise in β-lactamase inhibitors manufacturing under strict quality standards.

Key Factors Influencing Supplier Selection

1. Regulatory Compliance: Suppliers must meet international standards such as US FDA, EMA, and WHO GMP certifications.
2. Manufacturing Capacity & Scalability: Capacity to meet demand fluctuations, particularly during shortages.
3. Quality Assurance & Proven Track Record: Long-term validation of consistent API quality.
4. Cost Competitiveness: Balancing quality with pricing, especially for large-volume procurement.
5. Geographical Presence & Logistics: Supplier proximity can influence lead times and shipping costs.

Market Dynamics & Trends

• The rising burden of antimicrobial resistance has increased demand for APIs like relebactam, prompting industry investments and new supplier entrants.
• Indian and Chinese manufacturers dominate the generic API market due to cost advantages and expanding capacity.
• Patent expirations and regulatory changes further influence supplier landscape, opening opportunities for biosimilars or generic API production.

Regulatory & Quality Considerations

• Suppliers must provide comprehensive documentation, stability data, and batch certifications aligning with client regulatory requirements.
• Continuous audits and compliance checks are essential to maintain supply chain integrity.

Conclusion

The supply chain for cilastatin sodium, imipenem, and relebactam comprises a mix of established multinational corporations and robust Asian API manufacturers. Pfizer and Merck hold prominent roles in manufacturing and marketing, particularly for specialized combinations involving relebactam. Indian and Chinese API producers are significant suppliers, driven by cost efficiencies and expanding capacities.

Securing reliable suppliers requires careful evaluation based on quality standards, compliance, capacity, and geopolitical considerations. Strategic partnerships, due diligence, and diversified sourcing strategies will underpin resilient supply chains for these critical antibiotics.

Key Takeaways

• Major global suppliers include Pfizer, Merck, Novartis, Lupin, and Hetero, among others.
• Indian and Chinese manufacturers dominate the API supply landscape due to cost and capacity advantages.
• Regulatory compliance and quality assurance remain paramount in supplier selection.
• The increasing prevalence of resistant bacteria fuels demand for relebactam, making supplier stability critical.
• Diversification of suppliers mitigates risks related to geopolitical, manufacturing, or regulatory disruptions.

FAQs

Q1. Which companies are the primary manufacturers of imipenem and cilastatin sodium?
A1. Pfizer, Novartis, Lupin, Hetero, and Chinese manufacturers like Shanghai Highchem and Jiangsu Hengrui are key producers.

Q2. Who is the main supplier of relebactam globally?
A2. Merck & Co. is the primary developer and supplier of relebactam, marketed under the brand Recarbrio.

Q3. What are the key considerations when choosing a supplier for these APIs?
A3. Regulatory compliance, manufacturing capacity, quality assurance, cost, and logistical considerations.

Q4. Are there risks associated with sourcing APIs from Chinese or Indian manufacturers?
A4. While cost advantages are significant, risks include regulatory differences, quality variation, and geopolitical considerations, necessitating rigorous qualification and audits.

Q5. How does the global supply landscape impact drug pricing and availability?
A5. Limited or concentrated supply chains can lead to price fluctuations and shortages; diversification and establishing multiple sourcing agreements mitigate these risks.

References

[1] FDA Drug Master Files, 2022.
[2] Global Data Report on Antibiotic API Market, 2023.
[3] Industry analysis reports from IQVIA, 2022.
[4] Company websites and public filings of Pfizer, Merck, Novartis, Lupin, and Hetero.