Suppliers and packagers for generic pharmaceutical drug: exenatide synthetic

exenatide synthetic

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
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

Exenatide Synthetic: A Comprehensive Analysis of Global Suppliers and Market Dynamics

Exenatide synthetic, a glucagon-like peptide-1 (GLP-1) receptor agonist, has emerged as a critical therapeutic agent for managing type 2 diabetes. First approved by the FDA in 2005 under the brand name Byetta, this synthetic analog of exendin-4—a peptide isolated from the saliva of the Gila monster—works by enhancing insulin secretion, suppressing glucagon release, and delaying gastric emptying[1][3][7]. With the expiration of key patents and the introduction of generic formulations, the supply chain for exenatide synthetic has expanded globally, involving manufacturers across North America, Europe, and Asia. This report analyzes the current landscape of exenatide synthetic suppliers, regulatory challenges, pricing dynamics, and emerging trends shaping the market.

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Global Manufacturing Landscape of Exenatide Synthetic

Key Players in API Production

The production of exenatide synthetic active pharmaceutical ingredient (API) is dominated by a mix of established pharmaceutical giants and specialized peptide synthesis firms. LGM Pharma, a U.S.-based supplier, offers exenatide API with end-to-end regulatory support and a portfolio of over 2,000 APIs[1]. Hainan Shuangcheng Pharmaceuticals in China and Mallinckrodt in the U.S. are notable for their GMP-compliant manufacturing capabilities, though some suppliers, such as Polypeptide Labs and Sun Pharma, have shown reduced activity in recent years[1][9]. Indian manufacturers like Omgene Life Sciences and Biocon have also entered the market, leveraging cost-effective synthesis technologies to cater to global demand[9][12].

Regional Production Hubs

Asia-Pacific has become a focal point for exenatide synthetic production, with Chinese companies like Anhui Anke Biotechnology and Shanghai Wonder Pharmaceutical scaling output through advanced solid-phase peptide synthesis (SPPS) methods[6][11]. India’s Sun Pharmaceutical Industries and Shilpa Medicare Ltd. contribute significantly to API exports, supported by streamlined regulatory processes and competitive pricing[10][11]. In contrast, North American and European manufacturers, including Amylin Pharmaceuticals (now part of AstraZeneca) and Alkermes, focus on high-purity batches for branded formulations like Bydureon BCise[3][7].

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Regulatory Compliance and Quality Assurance

Adherence to International Standards

Suppliers must comply with stringent regulations, including the U.S. Drug Master File (USDMF) and European Certificate of Suitability (CEP). For instance, LGM Pharma holds USDMF certifications, ensuring its exenatide synthetic meets FDA standards for purity and potency[1][12]. Similarly, Hainan Shuangcheng adheres to China’s GMP guidelines, which align with ICH Q7 requirements for peptide synthesis[1][9]. The European Medicines Agency (EMA) mandates CEP certifications for suppliers like BCN Peptides, enabling seamless market access across the EU[12].

Challenges in Quality Control

The synthesis of exenatide synthetic involves a 39-amino-acid chain with a free N-terminus and amidated C-terminus, requiring precise control to avoid side reactions such as aspartimide formation or oxidation[6]. Purification via reverse-phase high-performance liquid chromatography (RP-HPLC) remains a bottleneck, with yields often reduced by 30–40% due to byproducts[6]. Suppliers like CPC Scientific have invested in orthogonal purification techniques to mitigate these losses, though scalability issues persist, particularly for smaller manufacturers[6].

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Supply Chain and Distribution Networks

Role of Distributors and Traders

Distributors such as Vital Overseas Private Limited (India) and Excel Pharma (Thrissur) bridge the gap between API producers and formulation developers. For example, Vital Overseas offers prefilled pens of Byetta (exenatide) at approximately ₹5,500 per box, targeting markets in South Africa and Southeast Asia[4]. Krishgen Biosystems provides ELISA kits for exenatide quantification, ensuring quality verification during intermediate storage[4].

Logistics and Cold Chain Management

Exenatide’s temperature-sensitive nature necessitates robust cold chain infrastructure. Suppliers like Biochemix Healthcare (Himachal Pradesh) utilize refrigerated transport for bulk API shipments, while AstraZeneca employs lyophilized formulations for Bydureon BCise to enhance stability[5][7]. However, the discontinuation of Bydureon BCise’s 2 mg/0.85 mL strength in 2025 has prompted distributors to prioritize liquid formulations with shorter shelf lives[5].

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Pricing Dynamics and Market Competition

Cost Drivers and Volatility

The average price of exenatide synthetic API fluctuates between $80–$800 per kilogram, influenced by raw material costs (e.g., Fmoc-protected amino acids) and regulatory updates[10][12]. For instance, the FDA’s 2024 approval of Amneal Pharmaceuticals’ generic exenatide triggered a 15% price drop, with 1.2 mL prefilled pens now priced at $300–$400 wholesale[8]. In contrast, branded products like Byetta retain higher premiums (over $5,000 per pen) in markets with limited generic penetration[4].

Impact of Patent Expirations

The expiration of AstraZeneca’s exclusivity for Bydureon BCise in 2025 has enabled entry by biosimilar manufacturers, though regulatory hurdles in the EU and Japan delay widespread adoption[5][8]. Meanwhile, Amgen and Novo Nordisk are exploring oral GLP-1 agonists, which could divert demand from injectable exenatide products[7].

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Synthesis Challenges and Technological Innovations

SPPS and Environmental Concerns

Conventional SPPS methods, while reliable, generate significant solvent waste (e.g., dimethylformamide)[6]. Suppliers like PolyPeptide Group are piloting green chemistry alternatives, such as microwave-assisted synthesis, to reduce dichloromethane use by 40%[6]. Chinese manufacturers are adopting continuous flow systems to enhance reaction efficiency, though peptide aggregation remains a technical barrier[6][11].

Advances in Purification

CPC Scientific has pioneered mixed-mode chromatography for exenatide purification, achieving >99.5% purity with fewer steps compared to traditional RP-HPLC[6]. These innovations are critical as regulators tighten impurity thresholds; the FDA’s 2024 guidelines now require控制在 0.1% for known degradation byproducts[12].

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Clinical and Commercial Implications

Supplier Influence on Drug Accessibility

The proliferation of API suppliers in India and China has reduced exenatide’s global median price by 22% since 2020, enhancing accessibility in low-income countries[9][12]. However, intermittent shortages—such as Mallinckrodt’s 2023 production halt due to facility audits—highlight vulnerabilities in decentralized supply chains[1][9].

Strategic Partnerships

Collaborations between API producers and formulation developers are reshaping the market. For example, Amylin Pharmaceuticals’ alliance with Eli Lilly accelerated the commercialization of Bydureon, while Amneal’s partnership with Aurobindo Pharma streamlined generic distribution[3][8].

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Future Outlook and Emerging Suppliers

Growth in Asian Markets

New entrants like Kyungdong Pharmaceutical (South Korea) and Shree Sidhhanath Industries (India) are expanding capacity, with projections indicating a 7% CAGR for exenatide API production through 2030[11]. BrightGene Bio-Medical Technology (China) plans to launch a high-throughput synthesis facility in 2026, aiming to cut production costs by 25%[11].

Biotechnological Disruptions

Gene synthesis firms, including Fishfa BioGenics, are exploring recombinant DNA techniques for exenatide production, potentially bypassing traditional SPPS limitations[11]. While still in preclinical stages, this approach could redefine manufacturing paradigms by 2030.

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Key Takeaways

1. Exenatide synthetic’s global supply chain is highly fragmented, with over 30 active suppliers across five continents.
2. Regulatory compliance (e.g., USDMF, CEP) remains a critical barrier for new market entrants.
3. Generic competition and patent expirations are driving price reductions, though logistical challenges persist.
4. Innovations in synthesis and purification technologies are essential to addressing yield and environmental concerns.

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FAQs

1. How can I verify a supplier’s GMP compliance?
Request audit reports and cross-check certifications with regulatory databases like the FDA’s Drug Establishments Current Registration Site[1][12].

2. Which regions dominate exenatide synthetic production?
China and India account for 60% of global API output, driven by cost-effective labor and advanced synthesis infrastructure[9][11].

3. Are there approved generic versions of Bydureon BCise?
No. The 2 mg/0.85 mL formulation was discontinued in 2025, though generics for Byetta (exenatide) are available since 2024[5][8].

4. What are the main challenges in exenatide synthesis?
Aspartimide formation and oxidative degradation during SPPS necessitate rigorous purification, often reducing yields[6][10].

5. Which companies are expected to enter the market by 2026?
Turtle Pharma (India) and HEC Pharm (China) have announced plans to commence exenatide API production in 2026[11].

References

1. https://pharmaoffer.com/api-excipient-supplier/glp1-agonists/exenatide
2. https://www.pharmacompass.com/manufacturers-suppliers-exporters/exenatide
3. https://www.clinicaltrialsarena.com/marketdata/exenatide/
4. https://dir.indiamart.com/impcat/exenatide-injection.html
5. https://www.drugs.com/availability/generic-bydureon-bcise.html
6. https://cpcscientific.com/exenatide/
7. https://pmc.ncbi.nlm.nih.gov/articles/PMC3351874/
8. https://www.drugs.com/availability/generic-byetta.html
9. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/exenatide
10. https://www.chemicalbook.com/Manufacturers-india/exenatide-acetate.htm
11. https://www.apisourcing.net/statistics/new-listed-api-manufacturers/
12. https://www.pharmacompass.com/active-pharmaceutical-ingredients/exenatide

Last updated: 2025-04-21