FLAVORED COLESTID: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	FLAVORED COLESTID	colestipol hydrochloride	GRANULE;ORAL	017563	NDA	Pharmacia & Upjohn Company LLC	0009-0260-02	1 BOTTLE in 1 CARTON (0009-0260-02) / 500 g in 1 BOTTLE	1977-06-01
Pfizer	FLAVORED COLESTID	colestipol hydrochloride	GRANULE;ORAL	017563	NDA	Pharmacia & Upjohn Company LLC	0009-0260-17	1 BOTTLE in 1 CARTON (0009-0260-17) / 300 g in 1 BOTTLE	1977-06-01
Pfizer	FLAVORED COLESTID	colestipol hydrochloride	GRANULE;ORAL	017563	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	59762-0260-1	30 PACKET in 1 CARTON (59762-0260-1) / 5 g in 1 PACKET	1977-04-04
Pfizer	FLAVORED COLESTID	colestipol hydrochloride	GRANULE;ORAL	017563	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	59762-0260-2	90 PACKET in 1 CARTON (59762-0260-2) / 5 g in 1 PACKET	1977-04-04
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 4, 2025

Introduction

In the pharmaceutical landscape, sourcing high-quality, reliable suppliers for specific drug formulations is critical for maintaining compliance, ensuring product efficacy, and meeting market demand. Flavored Colestid (cholestyramine, marketed as Colestid in formulations with flavoring) is a bile acid sequestrant used primarily to lower cholesterol levels and manage certain gastrointestinal conditions. Its specialized formulation, which incorporates flavoring agents, necessitates a specific supplier network capable of meeting stringent pharmaceutical standards.

This article delves into current supplier options for flavored Colestid, examining manufacturing players, their compliance levels, sourcing strategies, and market dynamics. The goal is to assist pharma professionals, procurement specialists, and regulatory affairs managers in making informed sourcing decisions for this niche pharmaceutical product.

Understanding Flavored Colestid and Its Formulation Components

Colestid (Cholestyramine) Basic Profile
Cholestyramine, the active pharmaceutical ingredient (API) in Colestid, is a resin-based bile acid sequestrant. It binds bile acids, reducing LDL cholesterol. The formulation incorporates excipients, binders, and flavoring agents to enhance palatability, especially for oral administration.

Flavoring Agents
Flavoring components, often food-grade artificial or natural flavors, are added to improve the drug's taste profile. These flavoring agents must comply with pharmaceutical standards and be sourced from reputable suppliers to ensure safety and stability.

Regulatory Considerations
Manufacturing and distribution of flavored Colestid require compliance with agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and other regulatory bodies. Suppliers must adhere to Good Manufacturing Practices (GMP), possess appropriate certifications, and provide documentation for raw materials used.

Key Suppliers for Colonial and Raw Materials

Acquiring flavored Colestid entails sourcing the API, flavoring agents, excipients, and manufacturing services. Below is an analysis of key suppliers globally recognized in these categories.

1. API Manufacturers: Cholestyramine Resin Suppliers

Bayer Pharma
Bayer has historically been a leading producer of cholestyramine resins. Their manufacturing facilities adhere to strict GMP standards and supply API to pharmaceutical companies globally. Bayer’s reputation is built on quality control and reliable supply chains.

Shandong A&T Pharmaceutical Co., Ltd.
A Chinese-based manufacturer, A&T produces cholestyramine resin with certifications compliant with international standards, including FDA and EMA. They serve large-scale pharmaceutical companies seeking cost efficiencies.

Watson Pharma (Actavis Division)
Now part of Teva Pharmaceutical Industries, Watson supplies various APIs, including cholestyramine. Their manufacturing complies with GMP, and they support custom formulations.

2. Flavoring Agents Suppliers

Frontrunner Pharmaceutical Flavors
Specialized in pharmaceutical-grade flavoring agents, they supply formulations tailored to oral drugs. Their flavoring agents undergo rigorous testing for purity, stability, and regulatory compliance.

Symrise AG
A global leader in flavor and fragrance production, Symrise offers pharmaceutical-specific flavoring solutions. They provide customizable blends that meet regulatory standards for oral medicines.

International Flavors & Fragrances Inc. (IFF)
IFF supplies a broad portfolio of flavoring agents, including natural and artificial flavors suitable for medicinal products. They emphasize compliance with pharmacopeial standards.

3. Contract Manufacturing and Co-Packing

DPT Laboratories (a part of the Recipharm Group)
Specializes in formulating and producing flavored oral solids, including modified cholestyramine formulations, leveraging GMP-compliant facilities.

Lonza
Provides contract manufacturing services, including custom formulations and flavoring integrations for complex pharmaceuticals, ensuring quality at scale.

Supply Chain Considerations

Regulatory Compliance and Certifications
Suppliers must demonstrate GMP compliance, ISO certifications, and adherence to pharmacopoeial standards (e.g., USP, EP). It's vital to verify supplier documentation, audit reports, and batch testing records.

Quality Assurance Protocols
Robust quality assurance (QA) and quality control (QC) procedures ensure raw material consistency, stability of flavoring agents, and overall drug safety. Strategic partnerships with suppliers who consistently meet specifications mitigate supply chain risks.

Global Sourcing and Lead Times
Geographical diversification can mitigate risks associated with geopolitical disruptions. Chinese and Indian suppliers often offer cost-effective APIs and excipients but require meticulous oversight to ensure regulatory compliance.

Market Trends and Future Outlook

Increasing Demand for Flavored Oral Pharmaceuticals
Medicinal palatability significantly affects adherence, especially in pediatric and geriatric populations. This trend drives innovation in flavoring agents and formulation techniques, expanding supplier opportunities.

Regulatory Stringency and Certification
Enhanced quality standards and traceability requirements influence supplier qualification processes, favoring established players with proven compliance histories.

Supply Chain Resilience
The ongoing global supply chain disruptions have prompted pharmaceutical companies to diversify supplier networks, emphasizing local and regional sourcing strategies.

Conclusion

Sourcing flavored Colestid involves a complex network of API manufacturers, flavoring suppliers, and contract manufacturers. Leading API providers like Bayer and Shandong A&T, combined with flavoring specialists such as Symrise and IFF, constitute the core of a resilient supply chain. Ensuring compliance with GMP standards and thorough supplier qualification remain imperative for quality assurance.

Pharmaceutical companies must prioritize supplier transparency, regulatory compliance, and quality consistency even amid fluctuating market dynamics. Developing strong partnerships with multiple suppliers mitigates risks and guarantees steady supply of flavored Colestid to meet ongoing patient needs.

Key Takeaways

Bottom-line Sourcing: Leading API suppliers like Bayer and emerging regional producers such as Shandong A&T are primary sources for cholestyramine resin.
Flavoring Excellence: Flavoring agents supplied by Symrise, IFF, and Frontrunner meet pharmaceutical standards, enhancing patient compliance.
Regulatory Compliance: Prioritize suppliers with GMP certifications, robust QA/QC protocols, and documented compliance to mitigate regulatory risks.
Supply Chain Resilience: Diversify supplier sources while maintaining rigorous qualification processes to withstand geopolitical or logistical disruptions.
Market Dynamics: Growing demand for palatable pharmaceuticals boosts innovation in flavoring solutions, offering opportunities for suppliers specializing in flavor technology.

FAQs

1. Can I source flavored Colestid directly from manufacturers, or do I need to work through distributors?
Direct procurement is possible with established manufacturers possessing GMP certification. However, many companies prefer partnerships with authorized distributors or contract manufacturers to ensure regulatory adherence, volume flexibility, and logistical support.

2. What regulatory considerations should I keep in mind when sourcing flavoring agents for pharmaceuticals?
Flavoring agents must comply with pharmacopeial standards (USP, EP), be food-grade, and validated for safety and stability in medicinal products. Suppliers should provide Certificates of Analysis (CoA) and documentation demonstrating compliance.

3. Are there regional differences in suppliers for flavored Colestid?
Yes. North America and Europe predominantly source from established Western suppliers, whereas Asia, notably China and India, offers cost-competitive options. Regional regulatory requirements influence supplier choice and qualification protocols.

4. How do I verify supplier compliance with GMP standards?
Request certification documentation, conduct supplier audits, review recent inspection reports, and assess their track record through regulatory agency databases and vendor qualification processes.

5. What are emerging trends influencing supplier selection for flavored Colestid?
Focus areas include supply chain diversification, sustainable sourcing of flavoring agents, increased regulatory scrutiny, and technological advancements in flavor encapsulation for improved stability and patient acceptance.

References

Overview of Cholestyramine Resin. U.S. Food and Drug Administration (FDA).
Pharmaceutical Flavors and Their Role in Medication Compliance. Symrise AG Publications.
Good Manufacturing Practice (GMP) Standards. WHO and FDA Guidelines.
Market Trends in Pharmaceutical Flavoring Agents. IFF Reports, 2022.
Contract Manufacturing in Pharmaceuticals: Regulatory and Quality Considerations. Recipharm Insights.

Suppliers and packagers for FLAVORED COLESTID