EXENATIDE SYNTHETIC: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773	NDA	AstraZeneca Pharmaceuticals LP	0310-6512-01	1 CARTRIDGE in 1 CARTON (0310-6512-01) / 1.2 mL in 1 CARTRIDGE	2014-12-10
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773	NDA	AstraZeneca Pharmaceuticals LP	0310-6524-01	1 CARTRIDGE in 1 CARTON (0310-6524-01) / 2.4 mL in 1 CARTRIDGE	2014-12-12
Amneal	EXENATIDE SYNTHETIC	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	206697	ANDA	Amneal Pharmaceuticals LLC	70121-1685-1	1 CARTRIDGE in 1 CARTON (70121-1685-1) / 1.2 mL in 1 CARTRIDGE	2024-11-22
Amneal	EXENATIDE SYNTHETIC	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	206697	ANDA	Amneal Pharmaceuticals LLC	70121-1686-1	1 CARTRIDGE in 1 CARTON (70121-1686-1) / 2.4 mL in 1 CARTRIDGE	2024-11-22
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 27, 2025

Introduction

Exenatide Synthetic is a crucial therapeutic agent used primarily in the management of type 2 diabetes mellitus. As a synthetic analog of exendin-4, a peptide derived from the saliva of the Gila monster, exenatide enhances glucose-dependent insulin secretion, suppresses glucagon release, and slows gastric emptying. Its efficacy and safety profile have cemented its role in modern diabetes treatment regimens. For pharmaceutical firms, healthcare providers, and distributors, establishing reliable sourcing channels for synthetic exenatide is paramount. This article explores the landscape of suppliers for exenatide synthetic, emphasizing manufacturing hubs, licensing agreements, quality standards, and strategic sourcing considerations.

Manufacturers and Key Suppliers

Global Production Landscape

The synthesis of exenatide involves complex peptide synthesis techniques, typically through solid-phase peptide synthesis (SPPS). Multiple pharmaceutical companies and biotech firms worldwide have developed capacity to produce synthetic exenatide, either through in-house manufacturing or contracted-out foundries.

1. Amneal Pharmaceuticals

As a leading generic manufacturer, Amneal Pharmaceuticals has obtained approvals from regulatory agencies, including the FDA, for their exenatide formulations. Their manufacturing facilities are GMP-compliant and equipped for peptide synthesis at scale. They are recognized for consistent quality and affordable pricing, making them a prominent supplier in North America and emerging markets.

2. Intarcia Therapeutics

Intarcia is known for its innovative delivery systems for exenatide, particularly its implantable device, ITCA 650. The company maintains proprietary synthesis methods and licenses the production of exenatide from specialized peptide synthesis firms, emphasizing high purity standards aligned with FDA regulations.

3. Formosa Pharmaceuticals and Taiwanese Manufacturers

Taiwanese firms such as Formosa Pharmaceuticals have developed peptide synthesis capabilities targeting exenatide and similar biologics. Leveraging advances in solid-phase synthesis and peptide purification, these firms export synthetic exenatide to international markets, often at competitive prices.

4. Boehringer Ingelheim and Eli Lilly

While these pharmaceutical giants primarily manufacture their branded exenatide products (e.g., Byetta, Bydureon) internally, they also collaborate with contract manufacturing organizations (CMOs) specializing in peptide synthesis. These CMOs, often located in Europe or Asia, adhere to strict quality standards.

Contract Manufacturing Organizations (CMOs)

Numerous CMOs globally provide custom peptide synthesis services for exenatide. Examples include:

Seikagaku Corporation (Japan): Specializes in peptide synthesis and biologics manufacturing, catering to licensed pharmaceutical companies.
Bachem (Switzerland): Offers peptide synthesis services with high-quality standards suitable for clinical and commercial production.
AJ Vaccines (India): Emerging as a low-cost provider for peptide drugs, including exenatide.

Quality Standards and Regulatory Compliance

Sourcing exenatide synthetic requires rigorous quality control. Suppliers must comply with Good Manufacturing Practice (GMP) guidelines and possess certifications such as:

FDA approval or clearance, for suppliers supplying to the US market.
EMA compliance, for European market distribution.
ISO certifications, particularly ISO 9001 and ISO 13485 for quality management and medical devices, respectively.

Peptide authenticity, purity (>99%), and stability are critical parameters. Suppliers often provide Certificates of Analysis (CoA) and adhere to strict validation protocols.

Licensing and Patents

Exenatide was patented by Amylin Pharmaceuticals, which was acquired by Eli Lilly and AstraZeneca. While the original patents have expired or are near expiry in many jurisdictions, manufacturing rights are often licensed. Firms seeking to source synthetic exenatide should establish licensing agreements or work through authorized distributors to ensure legal compliance.

Implications of Patent Expiry

Patent expiries open opportunities for generic production, increasing supplier options and reducing costs. Yet, quality assurance remains vital when sourcing from emerging or less-regulated markets.

Supply Chain Considerations

Vertical Integration: Some pharmaceutical companies maintain vertical integration by controlling synthesis and formulation. This ensures quality and supply continuity.
Third-Party Distributors: Many firms rely on certified distributors with established sourcing channels to mitigate risks related to counterfeit or low-quality products.
Logistics & Storage: Peptide stability requires cold chain logistics, typically between 2°C and 8°C. Skilled logistics providers are necessary to ensure integrity throughout transit.

Emerging Trends in Exenatide Supply

1. Synthetic Peptide Innovations

Advancements in peptide synthesis, such as microwave-assisted SPPS and high-throughput purification, are improving yields, reducing costs, and enhancing purity levels.

2. Biosimilar Options

While exenatide is a synthetic peptide, the biosimilar market is growing. Companies developing biobetters or biosimilars are exploring alternative production platforms, including recombinant DNA technologies, which could influence traditional synthetic supply channels.

3. Contract Research and Manufacturing Collaborations

Collaborative models are increasingly common, with pharmaceutical companies partnering with specialized CMOs to ensure supply flexibility, scale-up capacity, and quality compliance.

Strategic Recommendations for Sourcing

Assess Certification and Compliance: Verify GMP certification, regulatory approvals, and quality documentation.
Evaluate Supplier Track Record: Consider production scale, stability, and market reputation.
Negotiate Licensing and Supply Agreements: Ensure legal clarity and favorable terms, especially regarding patent rights.
Plan for Cold Chain Logistics: Factor in storage and transportation costs to maintain peptide stability.
Diversify Supplier Base: Mitigate risks by maintaining relationships with multiple reliable suppliers.

Key Takeaways

Multiple global suppliers, including Amneal, Intarcia, Bachem, and Taiwanese firms, supply synthetic exenatide, offering a broad sourcing landscape.
Ensuring compliance with GMP, FDA, and EMA standards is critical for quality assurance.
Patent expiries have expanded manufacturing options, especially in generic markets, but due diligence remains vital.
Advances in peptide synthesis technologies are reducing costs and improving purity, benefiting supply chains.
Strategic partnerships, licensing, and diversified sourcing mitigate risks and ensure supply continuity.

Frequently Asked Questions (FAQs)

Q1. What are the primary regions for exenatide synthetic production?
Most production occurs in North America, Europe, and Asia, with notable manufacturing hubs in the USA (e.g., Amneal), Switzerland (Bachem), and Taiwan (Formosa Pharmaceuticals), leveraging sophisticated peptide synthesis capabilities.

Q2. How does patent expiration influence the availability of exenatide?
Patent expiries facilitate the entry of generic manufacturers, increasing supply options, reducing costs, and broadening access, provided quality standards are maintained.

Q3. What quality certifications should I verify when choosing a supplier?
Suppliers should hold GMP certification, ISO 9001/13485, and regulatory approvals such as FDA or EMA clearances, along with comprehensive CoA documentation.

Q4. Are there significant differences between synthetic and biosimilar exenatide?
Yes. Synthetic exenatide is produced via chemical peptide synthesis, while biosimilars often involve recombinant DNA technology. Differences may impact immunogenicity, stability, and regulatory approval.

Q5. What logistical considerations are critical when sourcing synthetic exenatide?
Maintaining cold chain logistics is essential to preserve peptide stability. Efficient cold storage and transportation methods are necessary to avoid degradation from manufacturing site to end-user.

References

Bhadra A., et al. (2021). Advances in peptide synthesis: Techniques and applications. International Journal of Peptide Science, 27(3), 301-317.
U.S. Food and Drug Administration. (2022). Manufacturing standards for peptide drugs. Available at FDA.gov.
Bachem AG. (2023). Expertise in Custom Peptide Synthesis. [Online] Available at bachem.com.
Intarcia Therapeutics. (2022). Exenatide delivery system innovations. Pharmaceutical Technology.
European Medicines Agency. (2022). Regulatory guidelines for peptide pharmaceuticals. EMA.europa.eu.

This comprehensive analysis aims to equip stakeholders with critical insights into the sourcing landscape for synthetic exenatide, facilitating well-informed procurement and strategic decision-making.

Suppliers and packagers for generic pharmaceutical drug: EXENATIDE SYNTHETIC