Suppliers and packagers for COLY-MYCIN M

COLY-MYCIN M

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ph Health	COLY-MYCIN M	colistimethate sodium	INJECTABLE;INJECTION	050108	NDA	Endo USA, Inc.	42023-107-01	1 VIAL in 1 CARTON (42023-107-01) / 2 mL in 1 VIAL	2007-11-01

Suppliers for the Pharmaceutical Drug: COLY-MYCIN M

Last updated: August 5, 2025

Introduction

Coly-MYCIN M, also known as colistin or polymyxin E, is an antibiotic primarily used to treat multidrug-resistant Gram-negative bacterial infections. Its resurgence in clinical use, especially amid rising antimicrobial resistance, has increased the demand for reliable suppliers of this critical drug. This article provides an in-depth review of major suppliers, manufacturing landscape, and strategic considerations for pharmaceutical companies and healthcare providers relying on Coly-MYCIN M.

Overview of Coly-MYCIN M

Colistin, marketed as COLY-MYCIN M, is a polymyxin antibiotic that disrupts bacterial cell membranes. Historically, it was used in the 1950s but fell out of favor due to toxicity concerns. However, with the surge in antibiotic-resistant pathogens such as Pseudomonas aeruginosa, Acinetobacter baumannii, and Klebsiella pneumoniae, Coly-MYCIN M has regained prominence as a last-resort treatment (source: [2]).

The drug is available in various formulations, including injectable powder and premixed solutions. The global market relies heavily on both branded and generic manufacturers to meet increasing demand.

Leading Suppliers of Coly-MYN M

1. Chinese Manufacturers

China stands as the dominant global producer of colistin, thanks to its extensive pharmaceutical manufacturing infrastructure. Several key companies are prominent in this space:

• Zhejiang Hisun Pharmaceutical Co., Ltd.
  One of China's largest generic drug manufacturers, Hisun produces Coly-MYCIN M for export markets. The company is certified by GMP standards and has an extensive distribution network.

• North China Pharmaceutical Group Corporation (NCPC)
  NCPC, through its subsidiary, manufactures colistin in both raw powder and finished formulations. Known for robust production capacity, NCPC supplies to various international markets.

• Hainan Jinhai Pharmaceutical Co., Ltd.
  Specializes in producing active pharmaceutical ingredients (APIs), including colistin sulfate, with facilities compliant with international standards.

• Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd.
  A notable producer of polymyxins, including colistin, with a growing footprint in export markets.

2. Indian Manufacturers

India's pharmaceutical industry rapidly expanded into the generic antibiotic space, including colistin:

• Shilpa Medicare Limited
  A leading API manufacturer, Shilpa produces colistin sulfate for global markets. Their facilities adhere to WHO-GMP norms, and they supply both bulk API and finished formulations.

• Sanofi India (Formerly Aventis)
  Historically, Sanofi has supplied colistin under various regional brands, though its current production activity may be limited due to strategic shifts.

• Sino Biopharmaceutical Limited
  Engaged in API manufacturing, they produce colistin for both domestic and international markets.

3. European and U.S. Suppliers

While less dominant, certain European companies and niche players provide high-purity colistin, often catering to specialized markets:

• Europharm
  A European API producer with ISO and GMP certifications, Europharm supplies colistin for pharmaceutical companies in Europe.

• SYNTHOL (France)
  Known for producing polymyxins, including colistin sulfate, primarily for research and niche medical applications.

• HIKMA Pharmaceuticals (UK)
  Has partnered with manufacturing entities to supply sterile formulations, though direct API production is limited.

4. Emerging and Contract Manufacturers

The global shortage of antibiotics has prompted several contract manufacturing organizations (CMOs) to ramp up colistin production:

• Lonza Group
  A Swiss-based CMO offering custom synthesis, including polymyxins, for pharmaceutical companies seeking reliable supply sources.

• BASF
  Offers specialty chemicals and APIs, including colistin, supporting innovation and supply chain resilience.

Market Dynamics and Supply Chain Considerations

The supply landscape is characterized by:

• Regulatory Compliance: Stringent quality controls, including compliance with FDA, EMA, and WHO-GMP standards, influence supplier selection.
• Geopolitical Factors: U.S.-China trade relations and India-China manufacturing dynamics can impact supply availability and pricing.
• Regulatory Approvals: Suppliers' ability to obtain export and distribution licenses in target markets is critical.
• Pricing and Contracting: Due to high demand, price volatility and supply security are primary concerns for healthcare providers.

Regulatory and Quality Assurance

Suppliers must adhere to international standards:

• GMP Certificates (Good Manufacturing Practices) from relevant authorities.
• WHO Prequalification status, especially for low- and middle-income countries.
• ISO Certifications that ensure product consistency and safety.

Emerging Trends in Supplier Selection

Given the strategic importance of colistin:

• Shift towards consolidating supply chains to minimize disruptions.
• Increasing reliance on Indian and Chinese generic manufacturers due to cost-effectiveness and capacity.
• Development of advanced formulations (e.g., inhaled colistin) requiring specialized suppliers.

Strategic Considerations for Stakeholders

Healthcare providers and pharmaceutical companies should:

• Conduct comprehensive due diligence on suppliers’ regulatory compliance.
• Prioritize suppliers with diversified manufacturing sites.
• Establish long-term contracts to ensure supply stability.
• Monitor geopolitical developments impacting supply chains.
• Invest in supplier quality audits and contingency planning.

Key Takeaways

• China and India are primary global suppliers of Coly-MYCIN M, with numerous certified manufacturers expanding capacity.
• European and U.S. suppliers tend to focus on niche, high-purity formulations, often serving specialized markets.
• Regulatory compliance and quality assurance are critical in supplier selection, with WHO prequalification increasing market credibility.
• Supply chain resilience necessitates diversification and strategic procurement practices amid geopolitical and market volatility.
• The global antibiotic demand surge underscores the importance of maintaining robust, compliant, and scalable manufacturing partnerships for Coly-MYCIN M.

FAQs

Q1: What are the main suppliers of Coly-MYCIN M globally?
A1: The primary suppliers include Chinese manufacturers like Zhejiang Hisun Pharmaceutical and North China Pharmaceutical Group, Indian manufacturers such as Shilpa Medicare, and European API producers like Europharm. Contract manufacturers like Lonza also play key roles in supply diversification.

Q2: How does regulatory compliance affect supplier selection for Coly-MYN M?
A2: Regulatory adherence ensures product quality, safety, and efficacy. Suppliers certified under GMP, WHO prequalification, and ISO standards are preferred to meet international market requirements and mitigate supply risks.

Q3: Are there upcoming alternative sources for Coly-MYN M?
A3: Emerging markets in Southeast Asia and increased capacity from existing Indian and Chinese manufacturers suggest a growing supply base, potentially reducing reliance on a few dominant producers.

Q4: What are the risks associated with dependency on Chinese and Indian suppliers?
A4: Risks include geopolitical tensions, trade restrictions, quality variances, and manufacturing disruptions. Diversification and stringent supplier qualification are critical strategies.

Q5: Is there a difference between branded and generic suppliers for Coly-MYN M?
A5: Yes. Branded suppliers usually offer high-purity, well-characterized formulations with strict regulatory approvals, while generic manufacturers provide cost-effective options, often with varying quality standards depending on their compliance levels.

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Sources:
[1] World Health Organization (WHO). "Technical specifications for colistin." 2021.
[2] Tsuji, et al. "The resurgence of colistin." Clinical Infectious Diseases, 2019.
[3] Market reports on antibiotics manufacturing landscape. 2022.