Last updated: May 26, 2026
Tigecycline Suppliers: Who Manufactures, Supplies, and Licenses Supply for FDA and Global Markets
Tigecycline supply is concentrated in a small number of global sterile-injectable manufacturers that support brand and generic filings, plus specialty API and intermediate suppliers for the tigecycline active pharmaceutical ingredient (API). In the US, the key commercial supply footprint is dominated by FDA-licensed label holders and contract manufacturers for sterile lyophilized or freeze-dried powder for injection, while distribution is typically handled through wholesalers and specialty distributors rather than direct manufacturer-to-hospital sales.
Who supplies tigecycline in the US market?
The tigecycline market is served through FDA-labeled manufacturers (brand and authorized generics) and their manufacturing supply chains. Practically, the “supplier” question for tigecycline resolves into two layers:
- Regulatory label holder/manufacturer of record for the product marketed to hospitals and wholesalers.
- Contract manufacturing network that produces the sterile drug product (formulation, sterile fill-finish, lyophilization/packaging), and supplies intermediates and API from upstream chemical manufacturers.
What are the main tigecycline product formats and packaging suppliers typically cover?
Tigecycline is supplied as:
- Freeze-dried powder for injection in single-use vials
- Sterile presentation requiring aseptic manufacturing controls, sterile filtration steps (where applicable), lyophilization cycle validation, and container closure integrity testing
Supplier lists for sterile injectables are usually disclosed indirectly via:
- FDA Drug Establishment Registration and Listing (e.g., drug establishment inspectional coverage)
- DMF holder API/intermediates (for API suppliers)
- ANDA sponsor/manufacturer information (for generic product suppliers)
- Orange Book applicant/manufacturer fields (for marketed product)
Which companies are tigecycline API suppliers?
Tigecycline API supply typically comes from specialized antibiotic API producers that support DMFs or API supply agreements to branded and generic sterile injectables. API suppliers are not always publicly stated in a single consolidated list because upstream API is commonly under DMF confidentiality and licensing arrangements.
In the tigecycline supply chain, API suppliers usually manage:
- Synthetic route intermediates and antibiotic-assembly steps
- Impurity profiles tied to validated manufacturing processes
- Control strategy and release specifications to meet FDA and pharmacopoeial requirements
Where do API supplier identities show up in patent and regulatory documentation?
API and intermediate suppliers are most often evidenced in:
- DMF holders and authorized references in ANDAs
- ANDA manufacturing site disclosures (for API and/or drug product)
- Inspection and establishment datasets (drug substance and drug product registration)
What generic or authorized generic tigecycline suppliers exist?
US tigecycline supply includes branded and generic versions. Generic supply depends on:
- ANDA approvals for tigecycline drug product (dose strength and formulation)
- Contract sterile manufacturing capacity
- Drug product release and packaging capacity (single-use vials are capacity constrained during outages)
How do generic entry timelines affect supplier availability?
When exclusivity and patent barriers clear, additional ANDA manufacturers can add supply, typically through:
- A switch in primary sourcing of sterile fill-finish sites
- Additional packaging suppliers for vial labeling and carton production
- Expanded release testing capacity (QC labs)
This matters because tigecycline is a sterile injectable where manufacturing downtime can create rapid market constraints.
Which companies supply tigecycline to hospitals and distributors?
Direct “hospital supplier” in the US is usually:
- A pharmacy benefit channel (PBFM) or
- A wholesaler / distributor that carries tigecycline inventory sourced from the marketed label holder
The operational suppliers are therefore:
- Wholesalers (distribution and logistics)
- Specialty distributors (for hospital purchasing and contract management)
- Manufacturer of record (responsible for product release)
What causes tigecycline supply disruptions across suppliers?
Common disruption drivers for sterile injectables include:
- Lyophilization line capacity limits
- Sterile fill-finish facility uptime
- Sterility assurance and QC throughput bottlenecks
- Vial/stopper supply constraints affecting container closure assembly
What does the FDA listing show about tigecycline manufacturing suppliers?
The most direct evidence for “who supplies” is found in:
- FDA Orange Book entries for tigecycline (active ingredient and drug product)
- FDA Drugs@FDA label holder/manufacturer of record
- FDA SPL (Structured Product Labeling) and product listing metadata
- Drug Establishment Registration and Listing (DERL) for manufacturing sites
What fields matter when mapping tigecycline suppliers?
When building a supplier map, use:
- Manufacturer name in the Orange Book listing for each dosage form
- Applicant and manufacturer of record in Drugs@FDA
- Establishment registration site addresses for drug product and drug substance
How many tigecycline suppliers exist globally?
Globally, tigecycline supply is distributed across:
- API production hubs (chemical manufacturing)
- Sterile drug product production hubs (aseptic manufacturing and lyophilization)
- Regional marketing authorizations (country-specific label holders)
The count of “suppliers” depends on whether you count:
- API manufacturers
- sterile drug product manufacturers
- market authorization holders
In practice, the number of sterile drug product manufacturers is smaller than the number of potential upstream API producers because sterile injectable manufacturing is highly capacity constrained.
Which patent estate affects tigecycline supply and entry by new suppliers?
Supplier changes are constrained by:
- Brand and secondary patents around formulation, process, and method-of-use (where applicable)
- Orange Book-listed drug product patents for tigecycline
- Bioequivalence and patent certification in ANDA filings
How do Paragraph IV filings change the supplier landscape?
Paragraph IV certifications for tigecycline create:
- Litigation that can delay or block specific generic launches
- Settlement agreements that allocate market entry dates, limiting the number of competing suppliers initially
What is the Orange Book status of tigecycline and how does it map to suppliers?
Orange Book status is the most direct way to link:
- Patent expiration and listed drug product patents
- ANDA filing status (including carve-outs after FDA-accepted amendments)
- Potential window for additional suppliers entering the market
Supplier implications of Orange Book listing structure
For sterile injectables like tigecycline, a crowded Orange Book can delay:
- New ANDA product introductions
- Scaling of supply by new entrants
- Rapid substitution among suppliers during shortages
What generic entry risks exist for tigecycline suppliers?
Generic supplier risk typically comes from:
- Patent litigation (automatic 30-month stay for certain Paragraph IV certifications)
- Remand risk if FDA approvals face deficiencies
- Supply chain issues, especially for sterile fill-finish and lyophilized packaging
- Stability and reconstitution performance requirements
Which supply chain steps are the bottlenecks for tigecycline?
The highest-risk bottlenecks for supplier reliability in tigecycline are:
- Aseptic fill-finish line availability
- Lyophilizer cycle time and validated operating windows
- Sterile inspection capacity
- Primary packaging materials supply (vials, stoppers, caps, labeling)
- QC release testing capacity (microbial sterility and potency assays)
Key Takeaways
- Tigecycline supply is driven by a limited set of sterile injectable manufacturers plus upstream API and intermediate suppliers.
- The most actionable supplier mapping comes from FDA Orange Book, Drugs@FDA label metadata, and FDA establishment registration data.
- Supplier reliability is constrained less by labeling and more by sterile fill-finish and lyophilization capacity, with packaging materials as a secondary bottleneck.
- Patent and Orange Book barriers can limit the number of competing suppliers that can enter quickly after regulatory clearance.
FAQs
- How do I identify tigecycline drug product manufacturers using the Orange Book?
- Where can I find the manufacturing sites for tigecycline sterile fill-finish operations?
- Which data sources reveal tigecycline API suppliers and DMF holders?
- What causes tigecycline shortages across specific manufacturers?
- How does Paragraph IV litigation typically impact new tigecycline supplier entry?
References (APA)
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
- U.S. Food and Drug Administration. Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
- U.S. Food and Drug Administration. Drug Establishment Registration and Listing (DERL). https://www.fda.gov/drugs/guidance-compliance-regulatory-information/drug-establishment-registration-and-listing
