Suppliers and packagers for unasyn

unasyn

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	UNASYN	ampicillin sodium; sulbactam sodium	INJECTABLE;INJECTION	050608	NDA	Roerig	0049-0013-83	10 VIAL in 1 CARTON (0049-0013-83) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0049-0013-81)	1991-11-22
Pfizer	UNASYN	ampicillin sodium; sulbactam sodium	INJECTABLE;INJECTION	050608	NDA	Roerig	0049-0014-83	10 VIAL in 1 CARTON (0049-0014-83) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0049-0014-81)	1991-11-22
Pfizer	UNASYN	ampicillin sodium; sulbactam sodium	INJECTABLE;INJECTION	050608	NDA	Roerig	0049-0024-28	1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0049-0024-28) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE	1991-11-22

Suppliers for the Pharmaceutical Drug: UNASYN

Last updated: August 1, 2025

Introduction

UNASYN, a combination antibiotic comprising ampicillin and sulbactam, is utilized primarily for treating bacterial infections resistant to standard antibiotic therapy. As an essential medication in fighting infections, the supply chain for UNASYN involves multiple pharmaceutical manufacturers and authorized distributors globally. Ensuring a reliable source of UNASYN is critical for healthcare providers, especially amid global supply chain disruptions. This report provides an in-depth overview of key suppliers, manufacturing entities, and distribution channels for UNASYN, offering insights into the current landscape of its availability.

Overview of UNASYN

Originally developed by manufacturer Pfizer, UNASYN’s active ingredients—ampicillin and sulbactam—serve as a beta-lactam antibiotic combined with a beta-lactamase inhibitor, extending its spectrum of activity against resistant bacteria[1]. Its approval processes, regulatory status, and manufacturing are subject to strict compliance with pharmaceutical standards across jurisdictions. Market demand for UNASYN remains stable, given its role in hospitals and clinics, compounded by the global need for broad-spectrum antibiotics.

Primary Manufacturers and Licensed Suppliers

1. Pfizer Inc.

   As the original developer and primary manufacturer, Pfizer remains the principal supplier of UNASYN. The company maintains manufacturing facilities compliant with Good Manufacturing Practices (GMP) in the United States and Europe, ensuring consistent quality and supply[2]. Pfizer’s extensive global distribution network facilitates availability in North America, Europe, and select markets in Asia and Africa.

2. Other Licensed Manufacturers

   Besides Pfizer, certain pharmaceutical companies have secured licensing rights and manufacturing approvals for UNASYN or its components across different regions:

   • Sandoz (a Novartis division): Known for producing generic formulations of beta-lactam antibiotics, Sandoz manufactures ampicillin and sulbactam, often supplied through licensed agreements to regional distributors[3].

   • Cipla Limited: An Indian pharmaceutical giant, Cipla manufactures generic formulations of beta-lactams, including UNASYN equivalents, catering primarily to the Indian Subcontinent, Southeast Asia, and Africa[4].

   • Actavis (now part of Teva Pharmaceuticals): Teva has developed generic beta-lactam antibiotics, including formulations similar or identical to UNASYN, with distribution in multiple markets globally[5].

3. Contract Manufacturing Organizations (CMOs)

   Certain CMOs provide contract manufacturing and fill-finish services for UNASYN, ensuring capacity expansion amid increasing demand. These CMOs include well-known firms such as Catalent and Fareva, which adhere to strict GMP standards for sterile injectables[6].

Distribution and Supply Channels

• Authorized Distributors

  Pfizer and licensed manufacturers distribute UNASYN through authorized international and regional distributors. These distributors sometimes operate under strict procurement agreements to maintain quality control and supply chain integrity.

• Global Procurement Platforms

  Major procurement platforms, including the WHO’s prequalified suppliers and UN Pharmaceutical Suppliers, facilitate access to UNASYN for low- and middle-income countries (LMICs). These platforms focus on ensuring equitable access amid global health emergencies[7].

• Hospital and Retail Supply Chains

  In many markets, UNASYN is supplied directly to hospitals, clinics, and pharmacies through authorized wholesalers, like McKesson and Cardinal Health in the US, or local pharmaceutical distributors in emerging markets.

Regulatory and Patent Status Impacting Supply

• Regulatory Approvals: Regulatory agencies such as the FDA (US), EMA (European Union), and analogous agencies in other jurisdictions regulate the manufacturing and distribution of UNASYN. Timely approvals and renewals influence the availability of the drug.

• Patent and Licensing: Although UNASYN itself is a combination product, its components often face patent expirations, allowing multiple generics to enter the market, thereby diversifying supply sources[8].

Supply Chain Challenges

• Global Manufacturing Disruptions: The COVID-19 pandemic highlighted vulnerabilities in pharmaceutical manufacturing and supply chains, impacting UNASYN availability. Factory shutdowns, supply shortages of raw materials, and logistical challenges have led to intermittent shortages in some regions.

• Antibiotic Stewardship and Demand Fluctuations: Rising concerns over antibiotic resistance have prompted stricter regulations, influencing manufacturing priorities and supply dynamics. Balancing supply with stewardship efforts remains an ongoing challenge.

Emerging Trends and Future Outlook

• Expansion of Generic Manufacturers: The expiration of patents presents opportunities for multiple generic manufacturers, increasing supply diversity and potentially reducing costs.

• Regional Manufacturing Increase: To meet global demand, especially in LMICs, pharmaceutical companies are investing in regional manufacturing hubs, diversifying supply sources.

• Supply Chain Digitization: Integration of track-and-trace technologies enhances supply chain transparency, helping mitigate counterfeit risks and improve inventory management.

Conclusion

UNASYN’s supply landscape is characterized by a mix of original manufacturer production, licensed generics, and regional manufacturing partnerships. Pfizer remains the primary source, supported by licensed companies such as Sandoz, Cipla, and Teva, alongside CMOs facilitating manufacturing capacity. Supply reliability hinges on manufacturing consistency, regulatory compliance, and global health considerations. Healthcare providers and procurement agencies should consider diversifying their supplier base, engaging with authorized distributors, and maintaining visibility across the supply chain to ensure uninterrupted access to this vital antibiotic.

---

Key Takeaways

• Pfizer remains the dominant supplier of UNASYN, but multiple licensed generic manufacturers contribute significantly, especially in Asia and emerging markets.

• The expanding presence of regional manufacturing hubs and contract manufacturers enhances supply resilience amid disruptions.

• Regulatory approvals and patent expirations influence market entrants, increasing the diversity of suppliers.

• Supply chain disruptions, notably during the COVID-19 pandemic, underlined vulnerabilities requiring strategic procurement planning.

• Stakeholders should leverage authorized distributors, monitor regulatory developments, and adopt digital tools for supply chain transparency.

---

FAQs

1. Who are the primary manufacturers of UNASYN?
Pfizer is the original manufacturer and primary supplier globally. Licensed manufacturers such as Sandoz, Cipla, and Teva also produce generic versions or components, expanding the supply base across different regions.

2. Are there regional variations in UNASYN suppliers?
Yes. While Pfizer supplies the US and Europe predominantly, regional companies like Cipla and other Asian generics manufacturers supply markets in Asia, Africa, and Latin America.

3. How has the COVID-19 pandemic affected UNASYN supply?
The pandemic caused manufacturing disruptions, raw material shortages, and logistical challenges, leading to intermittent shortages in some areas. Diversification of suppliers and regional manufacturing capacity aim to mitigate such risks.

4. Can healthcare providers rely on generic equivalents of UNASYN?
Yes. Several licensed generic manufacturers produce formulations equivalent to UNASYN, often at a lower cost, provided they meet regulatory standards and are procured through authorized channels.

5. What future trends are expected in the supply of UNASYN?
Increased generic market penetration, regional manufacturing expansion, and improvements in supply chain management, including digital tracking, are expected to enhance supply stability. Additionally, patent expirations will likely result in more suppliers entering the market.

---

Sources

[1] Pfizer. "UNASYN Official Product Information." Pfizer.com.
[2] FDA Drug Approvals and Manufacturing Data.
[3] Sandoz Official Website. "Generic Antibiotics Portfolio." Sandoz.com.
[4] Cipla. "Generic Antibiotic Product Portfolio." Cipla.com.
[5] Teva Pharmaceuticals. "Generic Beta-Lactam Antibiotics." Teva-global.com.
[6] GMP Compliance Reports. International Conference on Harmonisation (ICH).
[7] WHO. "Prequalification of Medicines Programme." WHO.int.
[8] Patent Status and Market Entry Data. USPTO Patent Database.