Suppliers and packagers for amoxil

amoxil

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Us Antibiotics	AMOXIL	amoxicillin	CAPSULE;ORAL	062216	ANDA	Redpharm Drug	67296-1914-3	30 CAPSULE in 1 BOTTLE (67296-1914-3)	2022-09-15
Us Antibiotics	AMOXIL	amoxicillin	CAPSULE;ORAL	062216	ANDA	Redpharm Drug	67296-1914-4	40 CAPSULE in 1 BOTTLE (67296-1914-4)	2022-09-15
Us Antibiotics	AMOXIL	amoxicillin	CAPSULE;ORAL	062216	ANDA	Redpharm Drug	67296-1914-6	60 CAPSULE in 1 BOTTLE (67296-1914-6)	2022-09-15

Suppliers for the Pharmaceutical Drug: AMOXIL

Introduction
Amoxicillin, marketed under the brand name AMOXIL among others, is a widely prescribed antibiotic belonging to the penicillin class. It is utilized primarily to treat bacterial infections including respiratory tract infections, urinary tract infections, and skin infections. Given its pervasive use, a complex global supply chain supports its manufacturing and distribution. This article provides a comprehensive overview of the key suppliers involved in the production of AMOXIL, examining manufacturing giants, active pharmaceutical ingredient (API) suppliers, and finished dosage form manufacturers.

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Manufacturers of AMOXIL

Global pharmaceutical companies hold patents and licenses for AMOXIL, with production distributed across regions to meet demand efficiently. Notably, the original patent holder, GlaxoSmithKline (GSK), developed the drug in the 1970s. Over time, patent expiration, generic entry, and licensing agreements have diversified supplier bases.

1. GlaxoSmithKline (GSK)
GSK remains a significant name associated with AMOXIL. Although many patents expired, the company's ongoing manufacturing facilities continue to supply the drug, especially in regions where GSK maintains licensing agreements or regional marketing rights. GSK’s manufacturing plants, primarily in Europe and North America, produce both APIs and finished pharmaceuticals.

2. Sandoz (Novartis)
Sandoz, Novartis's generics division, is a major supplier of amoxicillin. They manufacture both raw APIs and finished products, especially in markets where generics dominate. Sandoz’s extensive global manufacturing footprint enhances their ability to supply AMOXIL efficiently across multiple regions.

3. Teva Pharmaceutical Industries
Teva, a leading generic pharmaceuticals manufacturer, supplies amoxicillin in various formulations. Teva’s integration of API production and finished drug manufacture provides a vertically integrated supply chain, ensuring quality and consistent availability. Their manufacturing facilities span North America, Europe, and Asia.

4. Sun Pharmaceutical Industries
As India's largest pharmaceutical company and a global player, Sun Pharma produces amoxicillin API and finished formulations for multiple markets. It leverages substantial manufacturing capacity in India and facilities worldwide, impacting the supply landscape significantly.

5. Lupin Limited
Another significant Indian generics manufacturer, Lupin produces amoxicillin in API form and finished tablets, supplying various regional markets and contributing to global supply chains.

6. Aurobindo Pharma
Aurobindo is prominent in the production of penicillin-class antibiotics, including amoxicillin. Its manufacturing facilities in India support global generic markets, catering to both API and finished formulations.

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Active Pharmaceutical Ingredient (API) Suppliers

The primary raw material for AMOXIL is amoxicillin trihydrate, the active pharmaceutical ingredient. Many of the aforementioned manufacturers also serve as API producers.

Key API Suppliers Include:

• Xinhua Pharmaceutical (China)
• Hainan Haiyan Pharmaceutical (China)
• Cambridge Laboratories (India)
• Dr. Reddy’s Laboratories (India)
• Cipla (India)
• Mead Johnson (USA, for some markets)

These API suppliers typically operate cGMP-compliant facilities, ensuring the purity and potency of amoxicillin for pharmaceutical manufacturing.

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Regional and Contract Manufacturing

Last updated: August 2, 2025

Manufacturers often utilize Contract Manufacturing Organizations (CMOs) to meet regional demand, especially in Asian markets. CMOs such as Hikvision Pharma, Famar, and Laptan facilitate the production of formulations, further diversifying supply sources.

Supply Chain Challenges and Dynamics

• Regulatory Compliance: API suppliers and manufacturers must adhere to stringent cGMP standards, with inspections and certifications crucial for market access. Disruptions in regulatory approval timelines can affect supplies.
• Raw Material Sourcing: The manufacturing of amoxicillin involves complex chemical synthesis that relies on specific precursors, which are sourced globally. Supply chain disruptions, geopolitical tensions, or raw material shortages can impact production.
• Geopolitical Factors: China and India dominate the API manufacturing sector for penicillins, including amoxicillin. Export restrictions, tariffs, or trade policies influence global availability.

Distribution and Supply Chain Distributors

Large pharmaceutical distributors such as McKesson, Cardinal Health, and local regional distributors serve as intermediaries, ensuring AMOXIL reaches pharmacies and hospitals efficiently. Their networks aggregate supply from multiple manufacturers, providing continuity amid manufacturing fluctuations.

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Emerging Trends and Future Outlook

• Generic Market Expansion: The expiration of patents and increased manufacturing capacity in India and China have led to a surge in generic amoxicillin supplies, broadening access worldwide.
• Supply Chain Resilience: Companies are investing in diversified manufacturing sites and supply chain transparency initiatives to mitigate risks associated with pandemics or geopolitical conflicts.
• Regulatory Alignment: Harmonizing international standards ensures smoother approval and distribution processes, supporting global supply continuity.

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Key Takeaways

• Leading global pharmaceutical firms including GSK, Sandoz, Teva, Sun Pharma, Lupin, and Aurobindo are primary suppliers of AMOXIL, handling both API production and finished formulations.
• API manufacturing is concentrated largely in China and India, with key suppliers exporting to regional markets and global manufacturers.
• Supply chain integrity hinges on strict regulatory compliance, raw material sourcing, and geopolitical stability.
• Contract manufacturing organizations play a vital role in boosting production capacity and flexibility.
• Expanding generic markets and supply chain resilience strategies will influence the availability and pricing of AMOXIL worldwide.

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FAQs

1. Are there significant differences in quality among suppliers of AMOXIL?
All reputable API and finished product manufacturers comply with international cGMP standards. Regulatory audits by agencies like the FDA or EMA ensure quality consistency, regardless of supplier origin.

2. How do patent expirations influence the supplier landscape for AMOXIL?
Patent expirations allow multiple generic manufacturers to produce AMOXIL, increasing supply diversity and reducing costs, which subsequently broadens the supplier base globally.

3. What regions are most reliant on Chinese and Indian suppliers for amoxicillin?
North America, Europe, and Africa heavily depend on Chinese and Indian API producers due to affordability and manufacturing capacity. This reliance heightens the importance of supply chain diversification.

4. How does supply chain disruption impact AMOXIL availability?
Disruptions such as raw material shortages, manufacturing delays, or geopolitical tensions can lead to shortages or increased prices, emphasizing the need for supply chain resilience measures.

5. Are there any recent regulatory changes affecting AMOXIL suppliers?
Regulatory adaptations, particularly during the COVID-19 pandemic, have temporarily eased some manufacturing and import restrictions, but ongoing compliance remains critical for market approval and supply continuity.

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References
[1] GlobalData Pharma Intelligence, "API Market Trends in Antibiotics," 2022.
[2] U.S. Food and Drug Administration, "ANDA Approvals and Active Pharmaceutical Ingredient Oversight," 2023.
[3] European Medicines Agency, "Manufacturing Regulations and Inspections," 2022.
[4] IMS Health Data, “Global Antibiotics Market Analysis,” 2021.
[5] Industry reports on penicillin and amoxicillin market share, Mordor Intelligence, 2023.