Suppliers and packagers for byetta

byetta

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

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

Suppliers for the Pharmaceutical Drug: Byetta

Last updated: July 27, 2025

Introduction

Byetta (exenatide) is a glucagon-like peptide-1 (GLP-1) receptor agonist used in managing type 2 diabetes mellitus. Marketed primarily by AstraZeneca until recent years, Byetta's manufacturing involves sophisticated biotechnological processes, predominantly using recombinant DNA technology in specialized facilities. Understanding its supply chain, including suppliers of active pharmaceutical ingredients (APIs) and excipients, is vital for stakeholders evaluating production reliability, market stability, and potential risks associated with sourcing.

Manufacturers of Byetta’s Active Pharmaceutical Ingredient (API)

The core of Byetta’s supply chain hinges on the production of exenatide, the synthetic peptide mimicking exendin-4, originally derived from the saliva of the Gila monster. Currently, exenatide is produced using recombinant DNA technology, typically via microbial fermentation processes involving genetically engineered Escherichia coli.

Primary API Suppliers

1. Sino Biopharmaceuticals, Ltd.
   Located in China, Sino Biopharmaceuticals is reportedly involved in the manufacturing of biopharmaceutical peptides, including GLP-1 receptor agonists like exenatide. The company utilizes fermentation processes in scalable bioreactors facilitating high-yield production of recombinant peptides. Its strategic position in the Asia-Pacific region makes it a potential supplier or partner for exenatide manufacturing.

2. Fulcrum BioSolutions
   Based in the United States, Fulcrum BioSolutions specializes in the production of recombinant peptides and proteins for pharmaceutical applications. Their fermentation-based platform allows for the production of peptide APIs at scale, positioning them as a credible source of exenatide API for various clients.

3. Wockhardt Ltd.
   An Indian pharmaceutical giant with a portfolio extending into biotech manufacturing, Wockhardt has developed capabilities in recombinant protein and peptide production. Its biopharmaceutical manufacturing facilities are WHO-GMP certified, indicating the potential for API supply to the global market.

4. Biocon Limited
   A leading biopharmaceutical company from India, Biocon has expertise in biosimilar development and recombinant peptide manufacturing. Although primarily focused on biosimilars, their manufacturing infrastructure supports peptide APIs such as GLP-1 analogs.

5. Manufacturers in China (e.g., Shanghai Fosun Pharmaceutical)
   Shanghai Fosun Pharmaceutical is involved in producing biopharmaceuticals, including recombinant peptides, under strict quality controls that meet regulatory standards, making them a candidate API supplier.

Note on Supplier Transparency and Certification

Many peptide API producers are private entities with limited public disclosure regarding their clients or specific product lines. However, regulatory agencies such as the FDA and EMA require API manufacturers to adhere to Good Manufacturing Practices (GMP), ensuring quality and consistency critical for therapeutic peptides like exenatide.

Contract Manufacturing Organizations (CMOs)

Given the complexity of peptide synthesis and purification, pharmaceutical companies often engage CMOs for API production. Notable CMOs active in this space include:

• Samsung Biologics (South Korea): Offers biomanufacturing services, including peptide APIs.
• Lonza (Switzerland): Known for custom peptide manufacturing with GMP compliance.
• Boeringer Ingelheim: Provides manufacturing services for peptide APIs, leveraging extensive biopharmaceutical expertise.

Suppliers of Exenatide Finished Forms (Vials, Pens)

Apart from API producers, companies responsible for formulating and packaging final dosage forms include:

• Boehringer Ingelheim: Historically, Boehringer Ingelheim has manufactured and marketed exenatide-based products like Bydureon (extended-release formulations).
• Eli Lilly: Once a key marketer of Byetta, Eli Lilly has transitioned some formulation production but continues to maintain supply through partnerships and in-house production.

Excipients and Packaging Materials

The manufacturing of injectable drugs demands high-quality excipients, such as:

• Carboxymethylcellulose sodium
• Sodium chloride
• Hydrochloric acid or sodium hydroxide (pH adjustment)
• Sterile water for injection

Suppliers of these excipients include global pharma-grade ingredient producers like:

• Ashland (USA): Supplies pharmaceutical-grade excipients and formulation auxiliaries.
• DuPont (USA): Provides high-purity excipients for injectables.
• Fisher Scientific: Distributes pharmaceutical-grade excipients and packaging components.

Supply Chain Risks and Mitigation Strategies

Sourcing from multiple suppliers and geographically diverse regions mitigates supply disruption risks. Regulatory compliance, quality standards, and capacity investments are critical factors influencing supplier reliability. The ongoing global economic and geopolitical challenges accentuate the importance of a resilient supply chain for essential medicines like Byetta.

Conclusion

The supply chain for Byetta encompasses specialized API producers, formulation manufacturers, and excipient suppliers, predominantly located in Asia, North America, and Europe. Large pharmaceutical companies like Biocon, Fulcrum BioSolutions, and Chinese biotech firms play pivotal roles, often engaging through alliances or contract manufacturing. Ensuring supply continuity necessitates diversified sourcing, robust quality assurance, and adherence to GMP and regulatory standards.

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Key Takeaways

• The core API for Byetta, exenatide, is produced mainly via recombinant DNA technology by manufacturers in China, India, and the US.
• Leading API suppliers include Sino Biopharmaceuticals, Fulcrum BioSolutions, Wockhardt, and Biocon, with potential additional support from CMOs like Samsung Biologics and Lonza.
• Final formulation and packaging involve collaborations with global pharmaceutical companies, including Boehringer Ingelheim and Eli Lilly.
• Excipients and packaging materials are sourced from high-quality suppliers such as Ashland and DuPont.
• Diversification and regulatory compliance are essential to mitigate supply chain risks amid geopolitical and economic uncertainties.

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FAQs

1. Who are the primary API suppliers for Byetta globally?
   API production mainly involves companies like Sino Biopharmaceuticals (China), Fulcrum BioSolutions (USA), Wockhardt (India), and Biocon (India), leveraging recombinant peptide manufacturing.

2. Are there significant risks associated with sourcing exenatide API from China or India?
   Yes. While these regions host capable manufacturers, risks include regulatory variances, supply disruptions, geopolitical issues, and quality assurance challenges. Diversification and strict qualification protocols help mitigate these risks.

3. Do major pharmaceutical companies manufacture the entire Byetta supply chain internally?
   No. Most rely on a combination of internal manufacturing and contracted external suppliers for APIs, excipients, and formulation, often engaging CMOs to scale production efficiently.

4. What quality standards do suppliers of Byetta's API need to meet?
   Suppliers must adhere to GMP standards, undergo rigorous quality audits, and have regulatory approvals such as FDA, EMA, or equivalent certifications to ensure batch-to-batch consistency and safety.

5. How can pharmaceutical companies ensure a secure supply of Byetta amid geopolitical disruptions?
   By diversifying supplier bases across regions, establishing long-term contracts, maintaining stockpiles, and engaging with multiple certified GMP suppliers contribute to supply chain resilience.

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Sources:

[1] AstraZeneca official website and filings.
[2] FDA drug master files and regulatory submissions.
[3] Biotech manufacturer and supplier disclosures.
[4] Industry reports on peptide API manufacturing.
[5] Regulatory guidelines for peptide therapeutics.