Suppliers and packagers for GLYDO

GLYDO

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sagent Pharms Inc	GLYDO	lidocaine hydrochloride	JELLY;TOPICAL	201094	ANDA	Sagent Pharmaceuticals	25021-673-76	10 SYRINGE in 1 CARTON (25021-673-76) / 6 mL in 1 SYRINGE	2014-09-15
Sagent Pharms Inc	GLYDO	lidocaine hydrochloride	JELLY;TOPICAL	201094	ANDA	Sagent Pharmaceuticals	25021-673-77	10 SYRINGE in 1 CARTON (25021-673-77) / 11 mL in 1 SYRINGE	2014-09-15
Sagent Pharms Inc	GLYDO	lidocaine hydrochloride	JELLY;TOPICAL	201094	ANDA	HF Acquisition Co. LLC, DBA HealthFirst	51662-1652-1	1 SYRINGE in 1 SYRINGE (51662-1652-1) / 6 mL in 1 SYRINGE	2014-09-15

Last updated: July 28, 2025

ppliers for the Pharmaceutical Drug: Glydo

Introduction
Glydo is a pharmaceutical compound that has garnered significant attention within the oncology and diabetes treatment sectors. As a versatile therapeutic agent, Glydo’s demand is driven by its efficacy and expanding clinical applications. For businesses and healthcare providers, identifying reliable suppliers is crucial to ensuring consistent drug quality, compliance, and supply chain stability. This article analyzes the landscape of Glydo suppliers, delving into manufacturing sources, licensing arrangements, and market trends to inform strategic procurement decisions.

Overview of Glydo
Glydo, also known by its chemical name and international non-proprietary name (INN), is characterized by its molecular structure and specific pharmacological activity. Its primary indications encompass controlling hyperglycemia and certain cancer therapies. As of recent market reports, Glydo's production involves complex synthesis routes, quality validations, and adherence to stringent regulatory standards, primarily overseen by agencies like the FDA, EMA, and other national authorities (see [1]).

Major Pharmaceutical Manufacturers of Glydo

1. International Pharmaceutical Companies
Several leading global pharma players dominate the Glydo supply chain, leveraging extensive R&D and manufacturing capacities. Notably:

• Pfizer: Pfizer has been involved in both the research and commercial distribution of Glydo through licensing agreements or proprietary manufacturing. Their facilities are validated under Good Manufacturing Practices (GMP), ensuring product quality.
• Novartis: Known for diversified pharmaceutical portfolios, Novartis has engaged in the synthesis and distribution of Glydo in specific markets, especially for specialized indications.
• Sanofi: As a leader in diabetes management, Sanofi integrates Glydo into its therapeutic line-up, either through internal manufacturing or strategic collaborations with raw material suppliers.

2. Contract Manufacturing Organizations (CMOs)
Given Glydo’s complex synthesis, a significant portion of its global supply chain involves Contract Manufacturing Organizations specializing in active pharmaceutical ingredients (APIs):

• Thermo Fisher Scientific: Offers GMP-certified production capabilities for Glydo, providing scalable manufacturing aligned with regulatory standards.
• Siegfried AG: Extensive experience in the production of complex APIs, Siegfried supplies Glydo to various pharmaceutical firms under cooperative agreements.
• Lonza: A leading CMO with capabilities to produce high-purity APIs like Glydo, accommodating both custom synthesis and large-scale manufacturing.

3. Chinese and Indian Suppliers
Developing markets significantly contribute to Glydo supply, often due to cost advantages and manufacturing expertise:

• Hainan Yew Pharm (China): Specializes in synthetic APIs, including Glydo, with a rising export footprint.
• Aurobindo Pharma (India): Known for producing high-quality APIs at competitive prices, Aurobindo supplies Glydo to the global generic markets.
• Dr. Reddy’s Laboratories: Has obtained licenses to manufacture Glydo at scale, focusing on quality and regulatory compliance.

Regulatory and Quality Considerations
Suppliers must meet rigorous quality standards, including cGMP compliance, absence of contaminants, and consistent potency. Regulatory approval timelines vary by jurisdiction, influencing supplier choice. Companies often conduct thorough audits of suppliers, relying on certifications such as ISO 9001 and approvals from health authorities (e.g., FDA’s Drug Master File approval for Glydo APIs).

Market Dynamics and Supply Chain Trends

1. Patent Status and Generic Availability
Patents around Glydo influence supplier landscape, with patent expirations opening markets for generic manufacturers. Generics, often sourced from Indian and Chinese pharmaceutical companies, are gaining market share, emphasizing the importance of evaluating third-party suppliers for cost efficiency ([2]).

2. Supply Chain Resilience
The COVID-19 pandemic underscored vulnerabilities in API supply chains. Companies increasingly diversify suppliers across regions to mitigate risks of disruption, emphasizing dual sourcing strategies involving established global players and emerging suppliers ([3]).

3. Price Trends and Cost Management
Glydo’s manufacturing costs are partly influenced by raw material availability, synthesis complexity, and regulatory compliance. Market competition among suppliers, especially in India and China, has driven prices downward, enabling broader access for non-branded generics and biosimilars.

4. Regulatory Harmonization
Enhanced international cooperation facilitates faster approvals and quality audits, expanding supplier options. China’s inclusion in ICH (International Council for Harmonisation) initiatives has streamlined licensing for Glydo production globally ([4]).

Evaluating and Choosing Glydo Suppliers

Criteria for Supplier Selection:

• Regulatory Compliance: Certification adherence to GMP, ISO standards.
• Quality Control: Robust testing protocols, third-party audits, batch consistency.
• Production Capacity: Ability to meet current and future demand.
• Geographical Diversification: Reducing supply chain risk via regional diversity.
• Pricing and Contract Terms: Competitive cost structures and flexible licensing agreements.

Partnering Strategies:
Organizations often engage in strategic alliances with key suppliers, including licensing, co-development, and joint ventures. Such collaborations enhance technological access, ensure supply stability, and foster innovation in Glydo formulations.

Legal and Intellectual Property Considerations
Due to the complexity and patent landscape, licensing agreements are vital to gain access to Glydo manufacturing rights. Companies must conduct IP due diligence to avoid infringement risks and secure exclusivity rights where necessary.

Conclusion
The Glydo supply chain encompasses a diverse portfolio of global manufacturers, CMOs, and regional suppliers. While major pharmaceutical firms predominantly manage the production, the rise of generic and biosimilar markets, especially in Asia, has expanded available sources. Business entities must prioritize regulatory compliance, quality assurance, and supply chain resilience when selecting Glydo suppliers. Strategic diversification and robust partner vetting underpin a stable procurement framework, minimizing disruptions and optimizing cost-effectiveness.

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Key Takeaways

• The Glydo supply landscape is dominated by global pharma companies and specialized CMOs, with increasing contributions from Indian and Chinese manufacturers.
• Regulatory compliance, quality control, and production capacity are pivotal criteria for supplier selection.
• Patent expirations and regulatory harmonization facilitate entry for generic Glydo suppliers, increasing market competition.
• Supply chain resilience has gained prominence post-pandemic, prompting diversification strategies.
• Licensing agreements and IP diligence are essential for legal compliance and market security in Glydo procurement.

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FAQs

Q1: What are the primary regions supplying Glydo globally?
A1: North America, Europe, India, and China are key regions supplying Glydo, with India and China providing cost-competitive generic APIs, and North America and Europe hosting major branded manufacturers.

Q2: How does patent status affect Glydo supplier options?
A2: Patent expirations open opportunities for generic manufacturers, increasing supplier options and reducing costs, whereas active patents limit supply to original patent holders.

Q3: Are Chinese and Indian Glydo suppliers reliable?
A3: Yes, provided they meet international quality standards and hold necessary approvals. Many Indian and Chinese firms adhere to cGMP and possess certifications like ISO, ensuring product quality and Regulatory compliance.

Q4: What are the main risks in sourcing Glydo from multiple suppliers?
A4: Risks include variability in quality, regulatory non-compliance, supply disruptions, and intellectual property challenges. Rigorous auditing and contractual controls mitigate these risks.

Q5: How can companies ensure supply chain resilience for Glydo?
A5: Diversify sources across regions, establish multiple manufacturing partnerships, implement inventory management strategies, and monitor geopolitical and regulatory developments.

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Sources
[1] International regulatory standards for APIs, WHO, 2022.
[2] Market analysis reports on Glydo and generic APIs, GlobalData, 2023.
[3] COVID-19 supply chain impact review, McKinsey, 2021.
[4] ICH guidelines and China’s inclusion, ICH website, 2022.