PLAZOMICIN SULFATE: Pharmaceutical manufacturers, suppliers, and packagers

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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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 29, 2026

Plazomicin sulfate is a branded, injectable aminoglycoside antibiotic (Plazomicin, Zemdri). The supply chain for plazomicin sulfate splits into three layers: (1) active pharmaceutical ingredient (API) manufacturing, (2) drug-product manufacturing including sterile filling, and (3) cold-chain logistics and regulatory release. Public sources consistently identify Sandoz and Theravance Biopharma as central commercial stakeholders for the Zemdri product, with manufacturing and supply executed through contract and affiliate arrangements. API and sterile-drug supply chain visibility is limited in public databases; the most reliable supplier signals come from FDA inspections/establishment listings, DMF/CEP holders where disclosed, and label manufacturing-site references.

Who supplies plazomicin sulfate API and finished Zemdri drug product?

Direct answer: The most dependable way to identify “who supplies” plazomicin sulfate is to map FDA-registered manufacturing establishments used for Zemdri drug product and to link those sites to the API DMF/letters of authorization or filings referenced by the product. In publicly accessible materials, the clearest named organizations tied to the product include Theravance Biopharma (developer/brand owner) and Sandoz (marketed through a partner arrangement), while the specific contract API and fill-finish suppliers typically appear as manufacturing site addresses rather than brand-named “suppliers” in marketing copy.

What entities are named in connection with Zemdri (plazomicin) supply?

Theravance Biopharma: brand owner and originator organization for plazomicin development and commercialization.
Sandoz: commercial partner for Zemdri in the US market.
FDA drug-product manufacturing establishments: listed as current manufacturing sites for Zemdri; these are the practical “suppliers” of sterile drug product.

How to interpret “supplier” in practice

For sterile injectables, “supplier” can mean:

API manufacturer (plazomicin sulfate bulk drug substance)
Drug-product manufacturer (sterile manufacture, sterile filtration, aseptic filling, lyophilization if applicable, and final packaging)
Labeler/distributor (responsible for OTC distribution and commercial supply, not necessarily manufacturing)

In litigation and regulatory audits, regulators and payers treat the drug product sites as primary supply-chain risk points, and the API sites as primary IP and batch quality risk points.

Which companies manufacture plazomicin sulfate (API) under DMF or supply agreements?

Direct answer: Public-facing documentation for plazomicin sulfate API is usually tied to DMFs and letters of authorization, which name filing holders rather than “approved suppliers” at the surface layer. Without the DMF holder names and the exact DMF number(s) linked to Zemdri in the FDA review record, supplier identification from public web sources is incomplete.

What the API supplier landscape typically looks like for plazomicin

Plazomicin is a complex aminoglycoside with tight control of:

stereochemistry and regioisomer purity
residual starting material and impurities
salt formation to plazomicin sulfate
microbiological controls and endotoxin limits downstream

As a result, API supply is usually consolidated into a small number of qualifying sites that have:

validated synthetic routes and impurity control strategies aligned with US specs
GMP manufacturing and stability data supporting the drug product
established regulatory interaction history

What FDA-registered manufacturing sites make Zemdri (plazomicin) sterile drug product?

Direct answer: The legally meaningful “supplier” list for drug product is the set of FDA-registered establishments for the finished Zemdri product. These sites control batch release for sterile injectable manufacture.

Where the supplier list is found

FDA product label section “Manufactured for” and “Packaged by”: name labeler and sometimes contract packagers
FDA’s “Drug Establishments Current Registration” and inspections history: establishes manufacturer-of-record and sterile facility mapping
FDA submission-linked chemistry and controls: ties to CMC manufacturing and controls

Supply-chain implications

Changes in drug-product manufacturing sites trigger comparability and stability updates and can affect availability.
Sterile filling capacity, aseptic processing throughput, and cold-chain distribution drive stock-out risk more than bulk API in many years for specialty injectable antibiotics.

What contract manufacturing and fill-finish capabilities support plazomicin injectable?

Direct answer: Zemdri is supplied as a sterile injectable. Contract manufacturing support is therefore dominated by:

aseptic processing capability
sterile filtration systems
controlled cleanroom environments and qualified operators
validated container-closure systems and packaging lines for vials

How to assess fill-finish “supplier risk”

Key operational constraints for sterile injectables include:

filter integrity test capacity
batch size and vial-count throughput
sterility assurance level (SAL) design and environmental monitoring frequency
end-to-end cold-chain handling during distribution

When do plazomicin sulfate supply constraints impact availability and launch of alternatives?

Direct answer: Availability risk typically spikes around:

sterile filling capacity utilization
post-inspection remediation or warning-letter remediation at drug-product sites
raw-material lead-time changes for complex API intermediates
packaging component shortages (vials, stoppers, seals)

What to monitor

FDA inspection updates for relevant manufacturing establishments
inventory drawdown indicators in wholesaler ordering patterns (when visible)
disruptions in contract manufacturing calendars
changes in label “manufactured for” addresses

How does the plazomicin sulfate supplier base affect generic or biosimilar entry risk?

Direct answer: Aminoglycoside generics (including ANDA-based injectables) face supply-chain and CMC barriers that mirror those of Zemdri:

API impurity profiles and salt form control
sterile fill-finish comparability and container-closure validation
stability and reconstitution/handling control

Even where patent barriers soften, generic entry can be delayed by:

difficulties matching impurity profiles to the reference listed drug
inability to demonstrate comparability of sterile manufacture and stability
slow qualification of sterile drug-product lines

What patent estate, DMF/CMC data access, and supplier qualification interact with supply?

Direct answer: Supplier selection is constrained by both regulatory and exclusivity-linked data access. A prospective generic supplier must:

either rely on its own DMF and CMC package, or obtain cross-referenced/authorized access to referenced data
meet reference product specs on impurity profiles and finished-goods performance
secure validated manufacturing controls for the sterile injectable

This often turns supplier qualification into a primary timeline driver.

Key Takeaways

“Supplier” for plazomicin sulfate should be defined as either API DMF holder/manufacturer or FDA-registered drug-product manufacturing establishments for Zemdri.
Publicly visible named entities tied to the Zemdri product include Theravance Biopharma and Sandoz, but the operational supply chain for batches is executed by FDA-registered manufacturing sites and contract sterile facilities.
For sterile injectables, availability risk is usually driven by drug-product sterile manufacturing and fill-finish capacity, with API supply as an upstream constraint.
Generic entrants depend on CMC comparability and supplier qualification, which can delay launch even when market access becomes legally feasible.

FAQs

1) How can I identify the actual drug-product manufacturer for Zemdri (plazomicin)?
Use the FDA establishment registrations for the Zemdri product and cross-check with label sections stating “manufactured for” / “packaged by.”

2) Are plazomicin sulfate API suppliers publicly listed in the Zemdri label?
Typically, API site information is not comprehensively listed in consumer-facing labeling; regulatory filings and establishment registrations are the practical sources.

3) What bottlenecks most often affect supply of sterile injectables like plazomicin?
Aseptic/sterile fill-finish line capacity, filtration and sterility assurance execution, vial/closure component availability, and cold-chain logistics.

4) How does manufacturer-site change affect regulatory approval for plazomicin drug product?
Site changes trigger CMC comparability work, stability updates, and regulatory reporting to maintain finished product specifications and quality.

5) What CMC challenges most often delay generic injectables against a reference like Zemdri?
Matching impurity profiles and salt-form controls for the API, then demonstrating comparability of sterile manufacturing controls and stability of the finished vials.

References

FDA. Drugs@FDA: Zemdri (plazomicin). U.S. Food and Drug Administration.
FDA. Current Drug Establishment Registration (CDER) and inspection information (establishment-level listings). U.S. Food and Drug Administration.
Zemdri (plazomicin) Prescribing Information. Labeling and manufacturing/packaging statements.

Suppliers and packagers for generic pharmaceutical drug: PLAZOMICIN SULFATE