Suppliers and packagers for generic pharmaceutical drug: amoxicillin; vonoprazan fumarate

amoxicillin; vonoprazan fumarate

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Phathom	VOQUEZNA DUAL PAK	amoxicillin; vonoprazan fumarate	CAPSULE, TABLET;ORAL	215153	NDA	Phathom Pharmaceuticals Inc.	81520-250-14	14 BLISTER PACK in 1 CARTON (81520-250-14) / 1 KIT in 1 BLISTER PACK (81520-250-01)	2023-11-08

Global Pharmaceutical Suppliers for Amoxicillin and Vonoprazan Fumarate: A Comprehensive Analysis

The global pharmaceutical supply chain for antibiotics and gastroesophageal therapies relies on a complex network of manufacturers, distributors, and regulatory frameworks. Amoxicillin, a penicillin-class antibiotic, and vonoprazan fumarate, a potassium-competitive acid blocker (PCAB), represent two critical drugs with distinct supplier landscapes. This report examines the key suppliers, manufacturing capabilities, regulatory compliance, and market dynamics shaping the availability of these medications.

---

Amoxicillin: Suppliers and Manufacturing Landscape

Domestic Production in the United States

USAntibiotics stands as the only U.S.-based manufacturer of amoxicillin and its combination drug amoxicillin clavulanate (Augmentin). Operating a 394,000-square-foot facility in Bristol, Tennessee, the company holds 12 New Drug Applications (NDAs) and produces over a billion doses annually[1]. Designated by the Department of Homeland Security as critical infrastructure, USAntibiotics prioritizes domestic supply chain resilience, addressing approximately 30% of annual U.S. antibiotic prescriptions[1]. Their production includes tablets, chewable tablets, capsules, and oral suspensions, with rigorous FDA compliance ensuring batch consistency[1].

International Suppliers and Global Distribution

While USAntibiotics dominates U.S. production, 22 international suppliers across eight countries contribute to the global amoxicillin supply[2][8]. Notable manufacturers include:

• Sinoway Industrial Co., Ltd. (China): Produces amoxicillin trihydrate under EP and USP monographs.
• United Laboratories (China): Supplies bulk API (active pharmaceutical ingredient) with GMP certification.
• Wellona Pharma (India): Exports 500mg amoxicillin capsules to hospitals and clinics in Africa, Southeast Asia, and South America[10].

Chinese suppliers account for 65% of global API production, with pricing ranging from $2–$30/kg depending on purity and order volume[13]. For instance, Zhengzhou Qizheng Trading Co. offers veterinary-grade amoxicillin powder at $2–$6/kg, while Xi’an International Healthcare Factory provides pharmaceutical-grade trihydrate powder at $20–$30/kg[13].

Regulatory and Quality Considerations

The FDA’s Drug Master Files (DMFs) system tracks 55 amoxicillin suppliers, requiring adherence to Good Manufacturing Practices (GMP)[7]. Manus Aktteva Biopharma (India), an ISO 9001:2015-certified supplier, emphasizes traceability for intermediates like amoxicillin trihydrate (CAS 61336-70-7), ensuring compliance with EU and WHO standards[3]. However, supply chain vulnerabilities persist, as seen in 2022–2023 shortages linked to raw material delays from Chinese API producers[8].

---

Vonoprazan Fumarate: Emerging Suppliers and Partnerships

Innovators in Acid-Blocking Therapies

Vonoprazan fumarate, a PCAB developed by Takeda Pharmaceuticals, inhibits gastric acid secretion with superior efficacy to traditional proton pump inhibitors (PPIs). Post-2022, partnerships between biopharmaceutical firms and contract manufacturers have expanded production:

• Evonik–Phathom Pharmaceuticals Alliance: Evonik manufactures vonoprazan API at FDA-inspected facilities in Tippecanoe, Indiana, and Dossenheim, Germany, supporting Phathom’s VOQUEZNA™ products for Helicobacter pylori eradication[6][11]. The collaboration leverages Evonik’s expertise in catalytic chemistry and multi-step synthesis, ensuring annual outputs exceeding 50 metric tons[11].
• Bio-Synth (India): Produces 750 kg/month of vonoprazan API and intermediates like pyridine-3-sulfonyl chloride (purity ≥99%)[5]. Their vertically integrated supply chain reduces reliance on Chinese intermediates, offering bulk pricing at $400–$600/kg for pharmaceutical-grade API[14].

Regional Supplier Networks

Asia-Pacific dominates vonoprazan API production, with Morepen Laboratories (India) and Apino Pharma (China) supplying 80% of regional demand[9][12]. European suppliers, including AXXO GmbH (Germany) and Istituto Biochimico Italiano (Italy), focus on high-purity fumarate salts (CAS 881681-01-2) for clinical trials, priced at $41–$78/gram[14]. Regulatory harmonization remains challenging; for example, Japanese manufacturers must comply with JDMF standards, while U.S. suppliers undergo biannual FDA audits[4][12].

---

Comparative Analysis of Supply Chain Dynamics

Geopolitical Influences

Amoxicillin’s supply chain is susceptible to geopolitical tensions, as 70% of API facilities are concentrated in China[2][8]. In contrast, vonoprazan’s patent exclusivity until 2030 has limited API diversification, with Takeda licensing production to regional CDMOs like Porton Pharma Solutions (China) and Alembic Pharmaceuticals (India)[12].

Pricing Volatility and Market Demand

Amoxicillin’s commoditized market results in price fluctuations: U.S. procurement costs rose by 18% in 2023 due to COVID-19-driven demand[7]. Vonoprazan, however, maintains premium pricing ($1,200–$1,500/month treatment cost), reflecting its novel mechanism and limited competition[11].

Sustainability Initiatives

Evonik integrates green chemistry principles, reducing solvent waste in vonoprazan synthesis by 40% through biocatalytic steps[11]. Similarly, USAntibiotics employs energy-efficient fermentation technologies, cutting CO₂ emissions by 15% per dose[1].

---

Strategic Recommendations for Stakeholders

1. Diversify API Sourcing: Healthcare systems should mitigate amoxicillin shortages by pre-qualifying suppliers in India and Mexico, as demonstrated by Mexico’s Fersinsa Gb[8].
2. Invest in CDMO Partnerships: Pharma companies developing PCABs should collaborate with Evonik-style CDMOs for scale-up agility and regulatory support[6].
3. Adopt Predictive Analytics: Real-time monitoring of Chinese API exports (e.g., via PharmaCompass’s database[7][12]) can anticipate disruptions.

---

Key Takeaways

• Amoxicillin relies on a fragile China-centric supply chain, with USAntibiotics critical for U.S. resilience.
• Vonoprazan fumarate production is expanding through strategic CDMO alliances, though costs remain high.
• Regulatory compliance and sustainability practices are becoming competitive differentiators for suppliers.

---

FAQs

1. Why is USAntibiotics vital to the U.S. amoxicillin supply?
USAntibiotics operates the sole FDA-approved facility for amoxicillin production, producing 1 billion+ annual doses and mitigating import dependencies[1].

2. Which countries lead vonoprazan API manufacturing?
India (Bio-Synth, Morepen) and China (Apino Pharma, Senova Technology) dominate, with Germany (Evonik) serving Western markets[5][9][11].

3. How do amoxicillin prices vary between suppliers?
Chinese API costs range from $2–$30/kg, while U.S.-formulated capsules are 50–70% pricier due to labor and compliance costs[10][13].

4. What certifications are essential for vonoprazan suppliers?
Suppliers require FDA approval, GMP compliance, and adherence to ISO 9001 standards for intermediate synthesis[4][5][14].

5. How is the vonoprazan patent landscape evolving?
Takeda’s patents expire in 2030, enabling generics; meanwhile, Phathom holds exclusive U.S. commercialization rights until 2035[11].

---

"The manufacture of vonoprazan requires multi-step syntheses involving complex chemistries. We provide customer-focused CDMO services in combination with excellent quality, enabling our trusted partner Phathom to fight gastrointestinal disorders worldwide."
— Thomas Riermeier, Head of Health Care, Evonik[6][11]

This analysis synthesizes data from regulatory filings, supplier databases, and industry reports to provide actionable insights for pharmaceutical procurement strategists.

References

1. https://jacksonhealthcare.com/companies/usantibiotics/
2. https://pharmaoffer.com/api-excipient-supplier/penicillins/amoxicillin
3. https://www.manusaktteva.com/api/Amoxicillin+trihydrate+Powder
4. https://www.pharmacompass.com/manufacturers-suppliers-exporters/vonoprazan-fumarate-tak-438
5. https://bio-synth.in/apis/vonoprazan-api-manufacturers-suppliers-in-india/
6. https://www.outsourcedpharma.com/doc/evonik-and-phathom-pharmaceuticals-partner-to-produce-novel-acid-blocker-vonoprazan-0001
7. https://www.pharmacompass.com/manufacturers-suppliers-exporters/amoxicillin
8. https://pharmaoffer.com/api-excipient-supplier/penicillins/amoxicillin/north-america
9. https://pharmaoffer.com/api-excipient-supplier/proton-pump-inhibitors/vonoprazan
10. https://wellonapharma.com/product/finished/amoxicillin-capsules-500mg
11. https://healthcare.evonik.com/en/evonik-and-phathom-pharmaceuticals-partner-to-produce-novel-acid-blocker-vonoprazan-178267.html
12. https://www.pharmacompass.com/manufacturers-suppliers-exporters/vonoprazan-fumarate
13. https://www.made-in-china.com/products-search/hot-china-products/Wholesale_Amoxicillin.html
14. https://www.made-in-china.com/products-search/hot-china-products/Vonoprazan_Fumarate.html

Last updated: 2025-04-21