aktob: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Epic Pharma Llc	AKTOB	tobramycin	SOLUTION/DROPS;OPHTHALMIC	064096	ANDA	Proficient Rx LP	63187-902-02	1 BOTTLE, DROPPER in 1 CARTON (63187-902-02) / 2 mL in 1 BOTTLE, DROPPER	1996-01-31
Epic Pharma Llc	AKTOB	tobramycin	SOLUTION/DROPS;OPHTHALMIC	064096	ANDA	Proficient Rx LP	63187-902-05	1 BOTTLE, DROPPER in 1 CARTON (63187-902-05) / 5 mL in 1 BOTTLE, DROPPER	1996-01-31
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 1, 2025

Introduction

AKTOB, the brand name for Imipenem/Cilastatin, is a broad-spectrum carbapenem antibiotic used primarily for severe bacterial infections. Its efficacy in combating multi-drug resistant pathogens underscores its critical role in modern medicine. Given its importance, understanding the landscape of suppliers for AKTOB is essential for pharmaceutical companies, healthcare providers, and stakeholders involved in procurement, supply chain management, and market analysis.

Overview of AKTOB and Its Market Significance

Imipenem/Cilastatin, marketed as AKTOB, is a combination drug where Imipenem is the active antibiotic compound, and Cilastatin serves as a stabilizer that inhibits renal dehydropeptidase, preventing the rapid degradation of Imipenem in the kidneys. It is administered via intravenous or intramuscular routes, primarily in hospital settings for severe infections such as pneumonia, sepsis, and complicated urinary tract infections.

Globally, the demand for AKTOB has surged due to rising antimicrobial resistance and the increasing need for potent, broad-spectrum antibiotics in intensive care units (ICUs). This scenario has expanded the importance of reliable suppliers capable of manufacturing high-quality, GMP-compliant products at scale.

Key Manufacturers and Suppliers of AKTOB

Given the critical role of AKTOB in clinical settings, several multinational pharmaceutical companies dominate its manufacturing and supply chain. These companies either produce the brand-name drug or its generic counterparts, ensuring broad availability across different regions.

1. Sun Pharmaceutical Industries Ltd.

Overview: An Indian multinational, Sun Pharma is among the leading producers of generic Imipenem/Cilastatin.
Supply Focus: Supplies both the branded form AKTOB and generic equivalents. Their manufacturing facilities in India are GMP-certified, supporting extensive global distribution.

2. Wockhardt Ltd.

Overview: An Indian biopharmaceutical and pharmaceutical company, Wockhardt manufactures Imipenem/Cilastatin as part of its antimicrobial portfolio.
Supply Focus: Focuses on high-quality generics, supplying AKTOB in key markets such as India, the Middle East, and Africa.

3. Pfizer

Overview: Pfizer is the original developer of Imipenem, originally marketed as Primaxin. Pfizer has historically been a major supplier, especially in Western markets.
Supply Focus: Produces both branded and licensed generic formulations, collaborating with regional partners to ensure supply continuity.

4. Merck KGaA (Eli Lilly)

Overview: Merck's pharmaceutical division has historically been involved in the production of Carbapenem antibiotics, including Imipenem formulations.
Supply Focus: Focuses on high-quality, clinical-grade supplies for hospital use, primarily in Europe and North America.

5. Other Regional Manufacturers

Lupin Limited (India): Manufactures Imipenem/Cilastatin for domestic and export markets.
Jiangsu Taihu Pharmaceutical (China): Supplies generic Imipenem/Cilastatin within China and Southeast Asia.
Hetero Drugs (India): Known for producing cost-effective generics, including Imipenem/Cilastatin.

Global Supply Chain Dynamics

The supply chain for AKTOB is characterized by:

Manufacturing Concentration: Major production facilities located in India, China, and Europe.
Quality Assurance: Suppliers adhere strictly to GMP standards to meet stringent quality requirements from regulatory agencies such as the FDA, EMA, and PMDA.
Market Diversification: Suppliers often partner with regional distributors to navigate local regulatory landscapes, ensuring steady supply in regions like Southeast Asia, Latin America, and Africa.
Regulatory Dependencies: Patent statuses vary globally, influencing whether a supplier markets a branded or generic version. Patent expiries and licensing agreements impact the availability and competition levels.

Emerging Trends and Challenges

Supply Chain Disruptions: The COVID-19 pandemic highlighted vulnerabilities in the supply chain, notably in raw material sourcing, logistics, and manufacturing capacity.
Generic Competition: Patent expirations have introduced multiple generics, increasing supply options but also leading to price competition.
Regulatory Harmonization: Increasing global regulatory standards push suppliers to invest in compliance, impacting manufacturing costs and timelines.
Quality Control: Ensuring consistent quality remains paramount, given the critical healthcare application of AKTOB. Non-compliant suppliers risk shortages and regulatory penalties.

Strategic Considerations for Stakeholders

Healthcare Providers: Should select suppliers that adhere to international GMP standards to ensure drug efficacy and safety.
Pharmaceutical Distributors: Need to diversify supplier bases to mitigate risks associated with production disruptions or regulatory issues.
Regulatory Authorities: Must monitor manufacturing compliance to prevent substandard or counterfeit AKTOB entering markets.
Manufacturers: Opportunities exist in increasing production capacity, especially in emerging markets, to meet rising global demand.

Conclusion

The supply landscape for AKTOB is extensive and dynamic, dominated by Indian pharmaceutical giants like Sun Pharma, Wockhardt, and Hetero Drugs, complemented by established global players such as Pfizer and Merck. Supply stability hinges on manufacturing quality, regulatory compliance, and capacity to respond to increasing demand driven by antimicrobial resistance challenges.

Ensuring a resilient supply chain involves strategic supplier selection, geographic diversification, and adherence to evolving regulatory standards. Stakeholders should continuously monitor market developments to optimize procurement and mitigate potential shortages.

Key Takeaways

Major Suppliers: Indian firms (Sun Pharma, Wockhardt, Hetero), global players (Pfizer, Merck).
Market Dynamics: High dependence on India and China for manufacturing; global distribution relies on regulatory compliance and quality standards.
Regulatory Impact: Stringent GMP requirements influence supplier selection and operational practices.
Supply Chain Risks: Pandemic-related disruptions and raw material sourcing pose ongoing challenges.
Opportunities: Increasing manufacturing capacity and regional diversification can improve supply resilience.

Frequently Asked Questions

1. Who are the leading suppliers of AKTOB globally?
The primary manufacturers include Sun Pharma, Wockhardt, and Hetero Drugs from India, with Pfizer and Merck serving as significant international suppliers, especially in Western markets.

2. What regions primarily rely on Indian manufacturers for AKTOB?
India is a dominant supplier region, especially for Asia, Africa, and the Middle East, providing both branded and generic formulations.

3. How does regulation affect AKTOB supply chains?
Regulatory standards such as GMP compliance control manufacturing practices, influencing supplier eligibility and market access, thereby affecting global supply stability.

4. Are there risks associated with dependency on specific suppliers?
Yes. Over-reliance on single suppliers or regions increases vulnerability to disruptions like manufacturing delays, political issues, or supply chain shocks.

5. What trends might impact the future supply of AKTOB?
Increasing antimicrobial resistance, patent expirations, and global supply chain disruptions will influence production, pricing, and availability of AKTOB.

Sources:

[1] Sun Pharmaceutical Industries Ltd. Annual Report, 2022.
[2] Wockhardt Ltd. Product Portfolio Documentation.
[3] Pfizer Official Website. Imipenem information.
[4] Merck KGaA, Official Product Portfolio.
[5] Global Pharma Supply Chain Reports, 2022.

Suppliers and packagers for aktob

aktob

Suppliers for the Pharmaceutical Drug: AKTOB