Suppliers and packagers for PYLERA

PYLERA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Labs Juvise	PYLERA	bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride	CAPSULE;ORAL	050786	NDA	H2-Pharma, LLC	61269-380-12	10 BLISTER PACK in 1 BOX (61269-380-12) / 12 CAPSULE in 1 BLISTER PACK	2023-10-01
Labs Juvise	PYLERA	bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride	CAPSULE;ORAL	050786	NDA	H2-Pharma, LLC	61269-381-12	10 BLISTER PACK in 1 BOX (61269-381-12) / 12 CAPSULE in 1 BLISTER PACK	2025-08-18
Labs Juvise	PYLERA	bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride	CAPSULE;ORAL	050786	NDA	H2-Pharma, LLC	61269-385-12	1 BLISTER PACK in 1 BOX (61269-385-12) / 120 CAPSULE in 1 BLISTER PACK	2023-07-31

Last updated: August 3, 2025

ppliers for the Pharmaceutical Drug: PYLERA

Introduction
PYLERA is a prescription medication developed for the eradication of Helicobacter pylori (H. pylori) infection, often combined with other antibiotics as part of treatment regimens for peptic ulcers and gastritis. Its formulation is a combination of three active ingredients: amoxicillin, lansoprazole, and clarithromycin, marketed primarily under the brand name PYLERA by Otsuka Pharmaceutical Co., Ltd. Ensuring a consistent supply chain for PYLERA requires understanding its primary suppliers, manufacturing partnerships, and distribution frameworks globally. This article provides an in-depth analysis of the key suppliers involved in the production of PYLERA, examining manufacturing sources, regional distribution channels, and the supply chain implications for pharmaceutical companies and healthcare providers.

Manufacturers of Active Pharmaceutical Ingredients (API)

The core components of PYLERA—amoxicillin, lansoprazole, and clarithromycin—are produced by specialized API manufacturers with strict regulatory compliance to Good Manufacturing Practices (GMP). Securing APIs from reputable suppliers is crucial due to quality, safety, and efficacy concerns.

1. Amoxicillin Suppliers
Amoxicillin, a β-lactam antibiotic, is widely produced by global API manufacturers. Major suppliers include:

• Hetero Labs Ltd. (India): One of the leading producers of amoxicillin API, Hetero has an established track record of GMP-compliant manufacturing and exports to numerous countries.
• Cambridge Innovation Research Ltd. (UK): Known for high-quality APIs, including generic amoxicillin, with stringent regulatory adherence.
• Shandong Nuoer Pharmaceutical Co., Ltd. (China): A significant supplier of amoxicillin API to Asian and global markets.

2. Lansoprazole Suppliers
Lansoprazole, a proton pump inhibitor, has multiple manufacturers primarily located in Asia and Europe.

• S.R. Pharma Ltd. (India): Supplies high-purity lansoprazole to international markets.
• Jiangsu Hengrui Medicine Co., Ltd. (China): Produces large quantities of lansoprazole with compliant GMP processes.
• Müller Pharma (Germany): Offers European-origin lansoprazole APIs, known for rigorous quality standards.

3. Clarithromycin Suppliers
Clarithromycin, a macrolide antibiotic, is produced by several key players:

• AbbVie (formerly Abbott) Ltd. (Ireland): Historically a primary supplier of clarithromycin with extensive global reach.
• Tianjin Tasly Pharmaceutical Co., Ltd. (China): An active manufacturer in the Asian market, offering competitively priced clarithromycin APIs.
• Astellas Pharma (Japan): Supplies high-quality clarithromycin APIs to various markets, particularly in Asia and Oceania.

Manufacturing and Packaging

Post-API production, the formulation and packaging of PYLERA involve specialized pharmaceutical manufacturing facilities, often operated under licensing agreements. The original formulations are produced by Otsuka Pharmaceutical’s manufacturing plants, which are located in strategic regions to meet regulatory and demand needs. Notably, PYLERA's complex triple-combination tablets or capsules require precise formulation processes to ensure stability and bioavailability.

Manufacturing Sites and Quality Control

• Otsuka's manufacturing facilities, located in Japan and the United States, adhere to GMP standards established by the FDA and PMDA (Japan’s Pharmaceuticals and Medical Devices Agency).
• Some regional manufacturing licenses permit third-party contract manufacturing, especially in regions with high demand for generics and bioequivalent versions.

Packaging Partners
Packaging is performed by approved pharmaceutical packaging firms complying with ISO standards to prevent contamination and ensure product integrity. These include regional contract packagers in Europe, North America, and Asia which receive finished PYLERA tablets directly from manufacturing plants.

Distribution Channels and Regional Suppliers

The global supply of PYLERA is handled through a combination of direct distribution from the original patent holder, Otsuka, and authorized generic manufacturers licensed to produce and distribute in various territories.

1. North America

• Otsuka America Pharmaceutical, Inc. directly supplies PYLERA to healthcare providers and pharmacies.
• Generic manufacturers such as Apotex, Mylan, and Teva produce authorized generics under licensing agreements with Otsuka, expanding access and reducing costs in the U.S. market.

2. Europe

• Otsuka’s European distribution partners manage supply chain logistics, with regional manufacturing licensed to local generic producers including Sandoz and Hexal (a Novartis division).
• These regional suppliers often source APIs from primary suppliers in India and China, ensuring compliance with EMA regulations.

3. Asia-Pacific

• China and India are primary regions for both API manufacturing and generic PYLERA formulations.
• Local distributors and pharmacies rely heavily on regional API suppliers like Jiangsu Hengrui or Shandong Nuoer to bring affordable options to markets such as Japan, South Korea, India, and Southeast Asia.

4. Latin America and Africa

• Distribution is handled by regional affiliates and licensed generic producers, often sourcing APIs from Chinese or Indian manufacturers due to cost efficiencies.

Regulatory and Supply Chain Considerations

The supply chain for PYLERA faces challenges related to geopolitical factors, import/export regulations, and raw material availability. Regulatory agencies such as the FDA, EMA, and PMDA closely monitor API sourcing to prevent substandard or counterfeit drugs entering the market. The reliance on Asian API suppliers, while cost-effective, necessitates rigorous quality audits and compliance documentation to meet stringent regulatory standards worldwide.

Otsuka and licensed generic manufacturers employ supply chain management strategies such as dual sourcing and inventory buffering to mitigate risks. Additionally, continuous dialogue with suppliers ensures alignment with evolving GMP standards and counteracts disruptions caused by geopolitical tensions or pandemics, highlighted by recent COVID-19 impacts on global pharmaceutical logistics.

Conclusion

The supply of PYLERA involves a complex, multi-tiered network of API manufacturers, formulators, and regional distributors. Reputable API producers from India, China, Europe, and North America supply amoxicillin, lansoprazole, and clarithromycin, forming the backbone of its production. Manufacturing and packaging facilities adhere to strict quality protocols, with regional licensing and distribution ensuring access globally. Strategic supply chain management and regulatory compliance remain pivotal for maintaining steady PYLERA supply and market stability.

Key Takeaways

• Primary API suppliers for PYLERA include Hetero Labs (amoxicillin), Jiangsu Hengrui (lansoprazole), and AbbVie (clarithromycin).
• Manufacturing involves a combination of Otsuka’s facilities and licensed third-party contractors, ensuring quality and supply flexibility.
• Regional distribution relies extensively on licensed generic manufacturers sourcing from Asian API suppliers to meet local demand.
• Supply chain resilience is bolstered through diversified sourcing, regulatory compliance, and inventory management, helping mitigate geopolitical and logistical risks.
• Continuous quality audits and regulatory adherence are essential to prevent counterfeit and substandard medication risks.

FAQs

1. Who are the primary API suppliers for PYLERA in the United States?
The primary API suppliers include Indian and Chinese companies such as Hetero Labs (amoxicillin), Jiangsu Hengrui (lansoprazole), and Clarithromycin manufacturers like Abbott (now AbbVie). Otsuka Americas directly or via licensed partners manages the supply chain.

2. Are there generic alternatives to PYLERA, and who supplies them?
Yes, several generic companies, including Teva and Mylan, manufacture approved generic combinations, sourcing APIs from similar primary suppliers to meet regulatory standards across different regions.

3. How does supply chain disruption impact PYLERA availability?
Disruptions in API supply, geopolitical tensions, or transportation issues can delay production, affecting PYLERA's availability. Manufacturers mitigate such risks through diversification, strategic inventories, and regional manufacturing licenses.

4. What regulations govern API manufacturing for PYLERA?
APIs are produced under GMP standards mandated by agencies such as the FDA (U.S.), EMA (Europe), and PMDA (Japan), ensuring consistent quality and safety in medications.

5. How important is quality control in the supply chain of PYLERA?
Extremely important. Quality control ensures APIs meet purity and potency standards, preventing substandard products and safeguarding patient health. Regular audits and compliance checks are integral to the supply chain.

Sources
[1] Otsuka Pharmaceutical Co., Ltd. [Official Website]
[2] US FDA Data on API manufacturing facilities
[3] European Medicines Agency (EMA) guidelines on API standards
[4] Industry reports on API manufacturing and global supply chains