Suppliers and packagers for tygacil

tygacil

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821	NDA	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	0008-4990-20	10 VIAL, SINGLE-DOSE in 1 CARTON (0008-4990-20) / 5 mL in 1 VIAL, SINGLE-DOSE (0008-4990-19)	2008-06-15
Pf Prism Cv	TYGACIL	tigecycline	POWDER;INTRAVENOUS	021821	NDA	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	0008-4994-20	10 VIAL, SINGLE-DOSE in 1 CARTON (0008-4994-20) / 5 mL in 1 VIAL, SINGLE-DOSE (0008-4994-19)	2017-02-08

Suppliers for the Pharmaceutical Drug: TYGACIL

Last updated: August 2, 2025

Introduction

TYGACIL is the brand name for tigecycline, a broad-spectrum glycylcycline antibiotic utilized primarily for complicated intra-abdominal infections (cIAI), complicated skin and skin structure infections (cSSSI), and certain cases of community-acquired pneumonia. Developed by Wyeth (now part of Pfizer), TYGACIL gained FDA approval in 2005. As with many critical antibiotics, access to TYGACIL hinges on an extensive supply chain involving manufacturing, distribution, and regulatory compliance. This article explores the current landscape of suppliers for TYGACIL, considering manufacturing hubs, distribution channels, and strategic partnerships underpinning its global availability.

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Manufacturers and Supply Chain Overview

1. Original Manufacturing by Pfizer (Formerly Wyeth)

Pfizer, following the acquisition of Wyeth in 2009, inherited the rights and manufacturing infrastructure for TYGACIL. The primary manufacturing facilities are based across North America and Europe, where high-potency pharmaceutical APIs (Active Pharmaceutical Ingredients) and finished dosage forms undergo rigorous quality control protocols conforming to Good Manufacturing Practices (GMP).

Pfizer's global production capacity ensures a steady supply primarily for North America, Europe, and select markets. The company's current manufacturing sites in the United States and Ireland serve as strategic hubs for the production of tigecycline API and finished products.

2. Contract Manufacturing and Licensing Agreements

Beyond Pfizer's internal manufacturing, strategic partnerships and licensing agreements with Contract Manufacturing Organizations (CMOs) are crucial for scaling production, reducing costs, and ensuring supply continuity—especially to meet global demand.

• India and China-based CMOs: Several Indian and Chinese pharmaceutical contractors produce tigecycline APIs and formulations under strict GMP standards and are often licensed or authorized by Pfizer. Chinese firms such as Shanghai Pharma and Indian generics companies have been involved in producing generic versions, which are sometimes subject to TMEs (Total Market Exclusivity) or patent challenges.

• Key CMOs and Manufacturing Partners:

  • Contract manufacturers in the EU and Asia capable of synthesizing advanced antibiotics
  • Specialized sterile injectables manufacturers for the final, ready-to-inject formulations

3. Patent and Regulatory Impact

While Pfizer holds the original patent and regulatory approvals, generic manufacturers often develop biosimilar or alternative formulations after patent expiry or under licensing arrangements. As of 2023, Pfizer’s patent protections on TYGACIL have largely expired or are nearing expiration in various jurisdictions, prompting increased supplier diversity.

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Distribution and Supply Channels

1. Pfizer’s Global Distribution Network

Pfizer maintains a comprehensive distribution network comprised of licensed distributors, wholesalers, and direct supply agreements with hospitals and governments. The company's distribution centers in North America, Europe, and Asia facilitate rapid distribution, ensuring a consistent supply chain, particularly in developed markets.

2. Authorized Distributors and Wholesalers

Major pharmaceutical wholesale networks such as McKesson, Cardinal Health, and API-based distributors like Unimed-Midlim in Latin America serve as secondary suppliers, ensuring accessibility across hospitals and clinics.

3. Regional and Market-specific Suppliers

In emerging markets, regional distributors and generic manufacturers sometimes source TYGACIL directly from Pfizer or from licensed generic producers. These suppliers often operate under regulatory alignments with local authorities, ensuring quality compliance.

4. Impact of Global Supply Disruptions

Recent supply chain disruptions—caused by geopolitical conflicts, manufacturing delays, or regulatory changes—have occasionally constrained TYGACIL access. Pfizer’s strategic stockpiles and regional manufacturing hubs help mitigate these effects.

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Emerging Suppliers and Generic Alternatives

1. Patent Status and Generics

Although initially protected, the patent landscape for tigecycline has evolved. In several jurisdictions, patent expiry has paved the way for generic firms to develop biosimilar or alternative antibiotic formulations.

2. Generic Manufacturers

• Indian pharmaceutical firms such as Cipla and Sun Pharma have either developed or are in process of developing tigecycline generics, subject to regulatory approvals.

• Chinese and South Korean companies have also expressed interest in manufacturing formulations for domestic and export markets, often collaborating with Pfizer under licensing agreements.

3. Regulatory Challenges and Approvals

Obtaining regulatory approval for generics involves demonstrating bioequivalence and obtaining WHO prequalification or equivalent approvals, which influence supplier diversity.

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Regulatory and Quality Considerations

Supply chain reliability correlates strongly with regulatory approval and quality assurance. Pfizer enforces stringent GMP standards across its manufacturing sites, which serve as benchmarks for authorized suppliers. Suppliers lacking adherence face regulatory sanctions or market bans, emphasizing the importance of compliance for continued supply.

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Conclusion: Supplier Landscape Summary

The supply of TYGACIL hinges on a complex network involving:

• Original manufacturer: Pfizer, with multiple production sites globally.
• Contract manufacturing partners: Especially in Asia, licensed for API synthesis and formulation.
• Distributors and wholesalers: Ensuring market access in both developed and emerging markets.
• Generic manufacturers: Increasing presence post-patent expiration, expanding global access.

As the global demand for potent antibiotics like tigecycline persists, strategic supplier diversification remains essential to ensuring sustainable supply chains, regulatory compliance, and affordability.

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Key Takeaways

• Pfizer remains the primary supplier for TYGACIL, leveraging its extensive manufacturing infrastructure.
• Contract manufacturing agreements, especially in Asia, expand global production capacity.
• Patent expiries have prompted increased generic producers, notably in India and China, diversifying the supplier base.
• Robust distribution networks facilitate market availability, but supply chain disruptions highlight the importance of regional manufacturing hubs.
• Regulatory compliance and quality assurance are pivotal in maintaining supply integrity and market confidence.

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FAQs

1. Are there approved generic versions of TYGACIL available globally?
Yes. In some jurisdictions, patents have expired or been challenged, allowing generic manufacturers to produce tigecycline formulations, subject to regulatory approval and bioequivalence testing.

2. Which companies are leading in the manufacturing of tigecycline APIs?
Pfizer formerly managed primary API manufacturing. Currently, several Indian and Chinese firms, under licensing agreements, are involved in API production, but Pfizer's own facilities remain key.

3. How does supply chain disruption affect TYGACIL availability?
Disruptions—caused by geopolitical issues, manufacturing delays, or regulatory hurdles—can lead to shortages, especially in emerging markets where reliance on regional suppliers is higher.

4. What regulatory hurdles do new suppliers face in entering the TYGACIL market?
They must demonstrate GMP compliance, approval of manufacturing facilities, and conduct bioequivalence studies to attain regulatory approval—steps that can be time-consuming and costly.

5. Is the supply of TYGACIL sufficient to meet global demand?
While Pfizer maintains a robust supply chain, emerging market growth and patent expirations are increasing the number of suppliers, helping to meet global demand—but supply continuity remains contingent on manufacturing and regulatory factors.

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References

1. [1] Pfizer. (2022). TYGACIL (tigecycline) Prescribing Information.
2. [2] European Medicines Agency. (2022). TYGACIL approval status in the EU.
3. [3] Indian Pharmacopoeia Commission. (2023). List of licensed manufacturers of antibiotics including tigecycline.
4. [4] World Health Organization. (2021). List of prequalified medicines for antibiotics, including tigecycline.
5. [5] Patent and Trademark Office records on tigecycline patent expirations across different regions.

Note: All data are accurate as of 2023 and subject to change with evolving regulatory and market conditions.