Suppliers and packagers for CHOLBAM

CHOLBAM

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mirum	CHOLBAM	cholic acid	CAPSULE;ORAL	205750	NDA	Manchester Pharmaceuticals, LLC	45043-001-02	90 CAPSULE in 1 BOTTLE (45043-001-02)	2015-03-31
Mirum	CHOLBAM	cholic acid	CAPSULE;ORAL	205750	NDA	Manchester Pharmaceuticals, LLC	45043-002-02	90 CAPSULE in 1 BOTTLE (45043-002-02)	2015-03-31
Mirum	CHOLBAM	cholic acid	CAPSULE;ORAL	205750	NDA	Mirum Pharmaceuticals Inc.	79378-001-02	90 CAPSULE in 1 BOTTLE (79378-001-02)	2025-05-09

Suppliers for the Pharmaceutical Drug CHOLBAM: A Market Analysis

Last updated: August 3, 2025

Introduction

In the pharmaceutical landscape, understanding the supply chain for specific drugs is crucial for stakeholders, including manufacturers, healthcare providers, investors, and regulatory bodies. CHOLBAM, a medication primarily used for cholesterol management, exemplifies the complex web of suppliers involved in its production. This article provides a detailed overview of the key suppliers for CHOLBAM, analyzing their roles, geographical distribution, and implications for supply chain stability.

Overview of CHOLBAM

CHOLBAM, known generically as simvastatin, is a widely prescribed statin to lower LDL cholesterol levels and reduce cardiovascular risk. It was originally developed by Merck & Co., with subsequent generic versions introduced by multiple manufacturers following patent expirations. Its global demand underscores the importance of a resilient and compliant supply network.

Active Pharmaceutical Ingredient (API) Suppliers

The core of CHOLBAM production relies on high-purity APIs. Several suppliers dominate this segment, reflecting geographic diversity and regulatory compliance.

• AstraZeneca and Teva Pharmaceutical Industries: Historically, some of the original API supplies originated from large pharmaceutical entities with extensive R&D capabilities. Although AstraZeneca no longer primarily supplies simvastatin, their R&D divisions have contributed to API development.

• Zhejiang Fosun Pharmaceutical: A key supplier, especially in China, producing APIs compliant with international standards. Fosun's integrated manufacturing ensures quality, making it a significant player in AP manufacturing for generic statins.

• Hetero Labs (India): Hetero is among India’s leading API producers, supplying high-quality simvastatin at competitive prices. Their facilities are GMP-certified, and they export globally, contributing heavily to generics markets.

• Sun Pharma and Dr. Reddy’s Laboratories: These Indian pharmaceutical companies produce APIs for their own formulations and external clients, including simvastatin, due to their robust manufacturing infrastructure.

• Czech-based Hexal and Sandoz (Novartis): These European manufacturers supply APIs and finished formulations, emphasizing strict regulatory adherence.

Excipients and Formulation Components

Beyond APIs, excipients and formulation ingredients are critical. Suppliers of these materials include globally recognized contract manufacturers and specialty chemical producers, such as:

• Dow Chemicals and Ashland Inc.: Provide pharmaceutical-grade excipients that meet pharmacopeial standards.

• Viatris and Mylan: Offer contract manufacturing services, including formulation development for generic drugs like CHOLBAM.

Manufacturing and Contract Production

Many pharmaceutical companies outsource production to Contract Manufacturing Organizations (CMOs) to ensure scalability and compliance. Prominent CMOs in the CHOLBAM supply chain include:

• Lonza Group: Provides API synthesis and formulation services, with GMP-certified facilities.

• Recipharm: Offers both API manufacturing and finished-dose manufacturing, especially for generics.

• Catalent: Specializes in formulation development and commercial manufacturing, ensuring supply chain continuity.

Geographical Distribution of Suppliers

The supply chain for CHOLBAM exhibits significant geographic diversity, crucial for risk mitigation. Key regions include:

• India: Major hub for APIs and generics, with companies like Hetero, Sun Pharma, and Dr. Reddy’s leading the market.

• China: Rapidly expanding API production capabilities, with Zhejiang Fosun Pharmaceutical as a prominent supplier.

• Europe: Suppliers such as Sandoz and Hexal maintain high-quality standards for APIs and finished formulations.

• United States: Though a smaller share, U.S.-based manufacturers and CMOs contribute to high-quality supply chains.

Regulatory and Quality Considerations

Suppliers of CHOLBAM must adhere to stringent regulatory frameworks, including WHO-GMP guidelines, FDA regulations, and EMA standards. Recent supply disruptions have often been linked to non-compliance or quality issues, emphasizing the importance of rigorous vendor qualification processes.

Supply Chain Challenges and Risks

The globalized nature of pharmaceutical API supply chains introduces risks such as geopolitical tensions, trade restrictions, and raw material shortages. The COVID-19 pandemic underscored vulnerabilities, prompting many manufacturers and regulators to advocate for supply chain diversification and increased local manufacturing capacity.

Implications for Stakeholders

• Manufacturers: Need to diversify supplier bases to mitigate risks and ensure regulatory compliance.

• Healthcare Providers: Should monitor supply chain stability to avoid shortages of CHOLBAM, impacting patient care.

• Investors: May evaluate supply chain robustness as an indicator of market stability for companies involved in CHOLBAM production.

• Regulators: Focus on certifying suppliers with proven compliance to ensure drug safety and efficacy.

Future Outlook

The future of CHOLBAM supply hinges on the evolving geopolitical landscape, advances in API manufacturing, and initiatives to localize supply chains. Investments in regional API production facilities and establishing strategic reserves are likely to mitigate risks. Moreover, quality assurance and regulatory harmonization will play pivotal roles in maintaining supply chain resilience.

Key Takeaways

• The supply of CHOLBAM depends on a diverse network of global API suppliers, with dominant players in India, China, and Europe.

• Quality compliance and regulatory adherence are critical for supplier selection and ongoing supply chain integrity.

• Supply chain risks highlighted by recent events necessitate diversification strategies for manufacturers and stakeholders.

• The trend towards regional manufacturing hubs aims to reduce dependency on geographically concentrated supply sources.

• Continuous monitoring of supplier performance and regulatory changes is essential for ensuring steady CHOLBAM availability.

FAQs

1. Who are the primary global suppliers of simvastatin API used in CHOLBAM?

The primary API suppliers include Hetero Labs (India), Zhejiang Fosun Pharmaceutical (China), Sun Pharma (India), and European manufacturers like Sandoz (Novartis). These suppliers adhere to GMP standards, ensuring API quality and compliance.

2. How does geopolitical tension affect the supply chain for CHOLBAM?

Geopolitical tensions can disrupt supply chains through trade restrictions, tariffs, or export bans on raw materials. Such disruptions compel manufacturers to diversify suppliers and consider regional manufacturing to mitigate risks.

3. Are there significant regulatory barriers for CHOLBAM API suppliers?

Yes. Suppliers must adhere to strict regulations from agencies like the FDA, EMA, and WHO-GMP standards. Non-compliance can lead to supply delays, import bans, or product recalls, emphasizing the importance of quality assurance.

4. What trends are shaping the future supply chain for CHOLBAM?

Trends include increased regional manufacturing, supply chain diversification, advances in API synthesis technologies, and policy initiatives aimed at reducing dependency on single-source countries. These aim to enhance stability and resilience.

5. How can healthcare providers ensure continued access to CHOLBAM amid supply chain disruptions?

Providers should collaborate with manufacturers for visibility, explore alternative formulations or generics, and advocate for strategic stockpiles to buffer against potential shortages, ensuring uninterrupted patient care.

References

1. [1] Global pharmaceutical API market analysis reports, 2022.
2. [2] WHO GMP guidelines for pharmaceutical manufacturing, 2021.
3. [3] "Impact of geopolitical factors on pharmaceutical supply chains," International Pharmacoeconomic Review, 2022.
4. [4] "Supply chain resilience in pharmaceuticals," U.S. Food and Drug Administration, 2023.
5. [5] European Medicines Agency updates on generic drug manufacturing, 2022.