Suppliers and packagers for GLUCOTROL XL

GLUCOTROL XL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	GLUCOTROL XL	glipizide	TABLET, EXTENDED RELEASE;ORAL	020329	NDA	Roerig	0049-0174-02	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0049-0174-02)	2013-05-09
Pfizer	GLUCOTROL XL	glipizide	TABLET, EXTENDED RELEASE;ORAL	020329	NDA	Roerig	0049-0174-03	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0049-0174-03)	2013-05-09
Pfizer	GLUCOTROL XL	glipizide	TABLET, EXTENDED RELEASE;ORAL	020329	NDA	Roerig	0049-0178-07	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0049-0178-07)	2013-05-09

Suppliers for the Pharmaceutical Drug: GLUCOTROL XL

Last updated: August 6, 2025

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Introduction

GLUCOTROL XL, a formulation of glipizide extended-release tablets, is a widely prescribed medication used primarily to manage type 2 diabetes mellitus. As a prominent drug in the antidiabetic market, understanding its suppliers is essential for stakeholders such as pharmaceutical manufacturers, healthcare providers, and investors. The drug’s global distribution hinges on a complex network of ingredient suppliers, manufacturing entities, and distribution channels. This analysis synthesizes publicly available data to delineate key suppliers for GLUCOTROL XL, emphasizing raw material sources, manufacturing partnerships, and distribution networks.

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Active Pharmaceutical Ingredient (API) Suppliers

1. Glipizide API Manufacturing

The core component of GLUCOTROL XL is glipizide, a second-generation sulfonylurea. Its synthesis requires high-quality APIs adhering to stringent regulatory standards such as FDA and EMA guidelines. Major API suppliers for glipizide typically include:

• Hetero Labs Limited (India):
  Hetero is one of the leading API manufacturers with a robust portfolio of antidiabetic APIs, including glipizide [1]. Its facilities have received WHO-GMP certification, ensuring quality standards suitable for global markets.

• Mitsubishi Tanabe Pharma Corporation (Japan):
  Known for extensive pharmaceutical R&D, Mitsubishi Tanabe produces high-purity APIs, including glipizide, often supplied to their branded formulations and international partners [2].

• Lake Chemical Co. Ltd. (China):
  An emerging API producer, Lake Chemical supplies generic glipizide APIs to various markets. Their manufacturing complies with international quality standards, although less prominent than Indian or Japanese counterparts.

• Aurobindo Pharma (India):
  A key contract manufacturer specializing in generic APIs, including glipizide, catering to both domestic and export markets. Their facilities are WHO-GMP accredited [3].

2. API Source Reliability and Certification

Suppliers such as Hetero and Aurobindo maintain rigorous quality control processes and have received multiple international certifications, positioning them as the primary sources of glipizide API for GLUCOTROL XL’s manufacturing. The selection of API suppliers often depends on factors like cost, regulatory compliance, and supply stability.

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Formulation and Finished Dosage Form Suppliers

1. Mylan (Part of Viatris):
Mylan has historically been a significant manufacturer and distributor of generic prescriptions, including extended-release formulations of glipizide like GLUCOTROL XL. Mylan’s manufacturing facilities in the United States and India provide completed dosage forms that are labeled and distributed globally [4].

2. Pfizer Inc.:
Pfizer originally developed GLUCOTROL XL and holds various manufacturing rights through licensing agreements. The company oversees formulation, quality assurance, and distribution for markets around the world. Pfizer’s manufacturing plants are certified to international standards, ensuring consistency and regulatory compliance [5].

3. Local and Contract Manufacturers:
In addition to multinational corporations, several regional generic drug manufacturers produce GLUCOTROL XL, often under licensing agreements with patent holders or through their own formulation development. These include firms in India, China, and Latin America, contributing to the global availability of the drug.

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Distribution and Supply Chain Dynamics

1. Global Distribution Networks

Distribution of GLUCOTROL XL relies on complex logistics involving wholesalers, pharmacy chains, and healthcare providers. Manufacturers like Pfizer and Viatris (which acquired Mylan) maintain extensive distribution networks that ensure rapid supply in North America, Europe, and Asia.

2. Supply Chain Challenges

The pharmaceutical supply chain for GLUCOTROL XL has faced disruptions during global crises such as COVID-19, impacting the availability of API sources and finished products. Organic API producers in India and China have occasionally experienced regulatory delays, which ripple through the supply chain. Diversification of API sources and manufacturing consolidation help mitigate these risks.

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Regulatory and Quality Assurance

The suppliers involved in GLUCOTROL XL uphold Good Manufacturing Practices (GMP) and are subject to regulatory audits from agencies like the FDA, EMA, and WHO. Certification status influences supplier selection, especially for markets with strict regulatory requirements. Transparency about supplier relationships is often limited due to business confidentiality, but top-tier suppliers commonly publish their certifications and compliance standards publicly.

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Market Trends and Future Supply Considerations

The demand for GLUCOTROL XL continues to grow, particularly in developing countries. Suppliers are expanding capacities, especially in India and China, leveraging cost advantages and regulatory approvals. Innovation in formulation and API synthesis techniques, including sustainable manufacturing practices, may influence future supplier dynamics. Additionally, patent expirations and generic competition are expected to diversify the supply landscape further.

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Conclusion

The supply network for GLUCOTROL XL encompasses a broad spectrum of APIs and finished formulations, predominantly led by Indian manufacturers such as Hetero and Aurobindo, Japanese firms like Mitsubishi Tanabe, and multinational giants such as Pfizer and Mylan (Viatris). These suppliers operate under strict regulatory oversight to ensure safety, efficacy, and quality, underpinning the drug’s global accessibility. Despite supply chain vulnerabilities, diversified sourcing and robust manufacturing standards safeguard the continued availability of GLUCOTROL XL.

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Key Takeaways

• Major API suppliers include India’s Hetero Labs, Aurobindo Pharma, Japan’s Mitsubishi Tanabe, and Chinese manufacturers like Lake Chemical, each holding GMP certifications.
• Formulation manufacturing is primarily conducted by Pfizer, Viatris (Mylan), and regional generic producers, ensuring broad distribution.
• Supply chain stability is increasingly vital amid geopolitical and pandemic-related disruptions; diversification in sourcing mitigates risks.
• Regulatory compliance remains a prerogative, with suppliers maintaining GMP certification and adherence to international standards to access global markets.
• Future trends indicate capacity expansion and technological innovation, which will further shape the supplier landscape for GLUCOTROL XL.

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FAQs

Q1: Who are the primary API suppliers for glipizide used in GLUCOTROL XL?
A: Leading API suppliers include Hetero Labs (India), Mitsubishi Tanabe Pharma (Japan), Lake Chemical (China), and Aurobindo Pharma (India), all adhering to global quality standards.

Q2: Which companies manufacture the finished GLUCOTROL XL formulation?
A: Pfizer holds a significant role as the original developer, with other generic manufacturers like Mylan (Viatris) producing and distributing the medication worldwide.

Q3: How does the supply chain for GLUCOTROL XL ensure quality and regulatory compliance?
A: Suppliers operate under GMP certifications from agencies like FDA and EMA, and undergo regular audits to maintain quality standards necessary for global distribution.

Q4: Are there risks associated with GLUCOTROL XL’s supply chain?
A: Yes, disruptions in raw material sourcing from China or India, geopolitical issues, and pandemic-related delays pose risks, mitigated through diversification and inventory management.

Q5: What are future trends affecting suppliers of GLUCOTROL XL?
A: Capacity expansions in emerging markets, technological advances in API synthesis, and increased regulatory scrutiny are shaping future supply dynamics.

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References

1. Hetero Labs Ltd. Official Website
2. Mitsubishi Tanabe Pharma Corporation, Corporate Brochure, 2022.
3. Aurobindo Pharma Annual Report, 2022.
4. Viatris (formerly Mylan) Official Website.
5. Pfizer Corporate Communications, 2022.