Suppliers and packagers for generic pharmaceutical drug: PLAZOMICIN SULFATE

PLAZOMICIN SULFATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cipla Usa	ZEMDRI	plazomicin sulfate	SOLUTION;INTRAVENOUS	210303	NDA	Cipla USA Inc.	69097-820-96	10 VIAL in 1 CARTON (69097-820-96) / 10 mL in 1 VIAL (69097-820-37)	2018-07-16
Cipla Usa	ZEMDRI	plazomicin sulfate	SOLUTION;INTRAVENOUS	210303	NDA	Achaogen, Inc.	71045-010-02	10 VIAL in 1 CARTON (71045-010-02) / 10 mL in 1 VIAL (71045-010-01)	2018-07-16
Cipla Usa	ZEMDRI	plazomicin sulfate	SOLUTION;INTRAVENOUS	210303	NDA	Cipla Therapeutics Inc.	80735-820-96	10 VIAL in 1 CARTON (80735-820-96) / 10 mL in 1 VIAL (80735-820-37)	2018-07-16

Suppliers for the Pharmaceutical Drug: Plazomicin Sulfate

Last updated: August 1, 2025

Introduction

Plazomicin sulfate is a next-generation aminoglycoside antibiotic developed to combat multidrug-resistant (MDR) bacterial infections, particularly complicated urinary tract infections (cUTIs) and bloodstream infections caused by carbapenem-resistant Enterobacteriaceae (CRE). Due to its targeted activity and reduced nephrotoxicity compared to traditional aminoglycosides, plazomicin has gained significant traction within the pharmaceutical industry. As the demand for effective MDR bacterial treatments increases globally, identifying reliable suppliers for plazomicin sulfate becomes strategic for healthcare providers, pharmaceutical companies, and institutional distributors.

Manufacturers of Plazomicin Sulfate

Achaogen, Inc.

Achaogen, Inc., the original developer and commercial manufacturer of plazomicin, was granted FDA approval for Zemdri™ (plazomicin) in 2018. Their manufacturing capabilities included comprehensive synthetic processes and robust quality assurance protocols to ensure drug purity and compliance with regulatory standards. Despite filing for bankruptcy in 2019 due to financial challenges, Achaogen's assets and rights related to plazomicin were acquired by other entities, making the original production line a key reference point.

Chemical and Active Pharmaceutical Ingredient (API) Manufacturers

While Achaogen held the rights and manufacturing licenses initially, its dissolution raised concerns about ongoing global supply. As a result, several chemical and API suppliers have stepped in or are developing methods to produce plazomicin sulfate, often through technology transfer agreements or licensing arrangements. These include:

• Pharmaceutical Contract Manufacturing Organizations (CMOs): Major CMOs with expertise in complex antibiotics production are increasingly involved in synthesizing plazomicin sulfate under strict quality control. Examples include Thermo Fisher Scientific, Wuxi AppTec, and Lonza Group, which possess the infrastructure for complex peptide synthesis processes involved in aminoglycoside manufacture.

• Independent API Suppliers: Some specialized pharmaceutical ingredient producers, primarily in India and China, have developed or are developing synthetic routes to produce plazomicin sulfate. Companies such as Hetero Labs, Dr. Reddy's Laboratories, and Zhejiang Hisun Pharmaceutical are known for advanced antibiotic APIs, though specific publicly available confirmation of plazomicin sulfate production from these firms remains limited due to confidentiality and licensing restrictions.

Authorized and Licensed Production Routes

Producing plazomicin sulfate requires sophisticated biosynthetic and chemical synthesis techniques, including fermentation, complex purification, and sulfate salt formation. Due to its patent status and proprietary manufacturing process, licensed manufacturing is typically restricted to entities holding licensing agreements with Achaogen or successors.

Emerging Suppliers and Market Participants

In response to growing antimicrobial resistance (AMR) concerns, the development of alternative sources is underway:

• Indigenous Pharmaceutical Manufacturers in Asia: Several regional firms are investing in antibiotic R&D, aiming to develop biosimilar or generic versions of plazomicin sulfate. These efforts are often in the preclinical or early clinical trial phases and require rigorous regulatory approval before market entry.

• Academic and Contract Research Institutions: Some university-affiliated labs are exploring synthetic pathways and potential production techniques but are not immediate suppliers.

Distribution and Supply Chain Challenges

Given that Achaogen's financial difficulties curtailed large-scale production post-2019, the global supply of plazomicin sulfate has faced disruptions. The emergence of new manufacturing licenses and partnerships is critical to stabilize the supply chain. Major pharmaceutical distributors such as McKesson, Cardinal Health, and AmerisourceBergen have indicated interest in sourcing plazomicin sulfate from licensed APIs to fill unmet clinical needs.

Regulatory and Quality Considerations

Suppliers must adhere to stringent Good Manufacturing Practices (GMP) to ensure pharmaceutical-grade impurities are minimized. Regulatory bodies, including the FDA and EMA, require comprehensive documentation, validation, and stability data before approving imports or local manufacturing by third-party suppliers.

Future Outlook

The global strategy is leaning toward expanding licensed production and forging new licensing agreements for plazomicin sulfate. Governments and international health organizations are emphasizing the importance of scaling up production to address MDR bacterial threats, thus incentivizing higher capacity manufacturing.

Key Takeaways

• The original manufacturer, Achaogen, was pivotal but faced commercial challenges, leading to a diminished direct supply.
• The production of plazomicin sulfate now increasingly depends on licensed API producers, primarily in India and China.
• Contract Manufacturing Organizations (CMOs) play a vital role in scaling up and ensuring GMP compliance.
• Regulatory hurdles and intellectual property restrictions influence procurement options.
• The market is evolving with emerging regional manufacturers and licensing agreements to improve supply stability.

FAQs

1. Is plazomicin sulfate currently available from multiple suppliers?
Availability is limited due to licensing and proprietary manufacturing processes. While some licensed API producers operate in India and China, supply may be constrained, requiring careful vetting and compliance checks.

2. What should healthcare providers consider when sourcing plazomicin sulfate?
Providers should verify suppliers' GMP compliance, inquire about certificates of analysis, and confirm regulatory approvals to ensure safety, efficacy, and quality.

3. Are biosimilars or generics of plazomicin sulfate in development?
Currently, no biosimilars are FDA-approved. Development efforts are ongoing by regional pharmaceutical companies aiming to produce biosimilar versions, pending regulatory clearance.

4. How does licensing impact the availability of plazomicin sulfate?
Licensing agreements restrict manufacturing to authorized entities, impacting market competition, pricing, and supply volume. Expanding licensing can improve access and reduce costs.

5. What are the future prospects for the supply of plazomicin sulfate?
Increasing investments from biotech and pharma companies, along with strategic licensing, are poised to enhance global supply, addressing unmet clinical needs against MDR pathogens.

---

References

1. FDA. "FDA Approves Zemdri (plazomicin) for complicated urinary tract infections." 2018.
2. Achaogen, Inc. Company filings and press releases, 2018–2019.
3. European Medicines Agency. "Marketing authorization for Zemdri." 2018.
4. Market intelligence reports. "Global Antibiotic API Market," 2022.
5. WHO. "Global Antimicrobial Resistance Surveillance System (GLASS)." 2021.

---

This analysis provides essential insights for pharmaceutical procurement, strategic planning, and market development regarding plazomicin sulfate. Staying informed about licensing, manufacturing developments, and regulatory changes is critical for stakeholders aiming to secure reliable supply chains.