Suppliers and packagers for ZIRGAN

ZIRGAN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch And Lomb	ZIRGAN	ganciclovir	GEL;OPHTHALMIC	022211	NDA	Bausch & Lomb Incorporated	24208-535-15	1 TUBE, WITH APPLICATOR in 1 CARTON (24208-535-15) / 1.5 g in 1 TUBE, WITH APPLICATOR	2010-04-30
Bausch And Lomb	ZIRGAN	ganciclovir	GEL;OPHTHALMIC	022211	NDA	Bausch & Lomb Incorporated	24208-535-35	1 TUBE, WITH APPLICATOR in 1 CARTON (24208-535-35) / 5 g in 1 TUBE, WITH APPLICATOR	2010-04-30

Suppliers and packagers for ZIRGAN

Last updated: May 29, 2026

ZIRGAN Suppliers: Who Manufactures, Supplies, and Distributes Zirgan (Ganciclovir Ophthalmic Gel) Globally?

Zirgan (ganciclovir) is an ophthalmic antiviral gel. Supplier mapping is contract-manufacturing and distribution led, with brand ownership tied to the authorized marketing party in each territory. This analysis provides the supplier landscape at the level commonly used for R&D, licensing, procurement, and supply-chain risk.

Who are the key suppliers for ZIRGAN (ganciclovir ophthalmic gel) across manufacturers and distributors?

Zirgan supply typically separates into three layers: (1) active pharmaceutical ingredient (API) suppliers for ganciclovir, (2) finished-goods contract manufacturing for the ophthalmic gel, and (3) regional marketing authorization holders and distribution networks.

How is ZIRGAN supply usually structured?

• API (ganciclovir): supplied by chemical/pharmaceutical API makers and wholesalers into European GMP finished-goods sites.
• Finished gel (Zirgan): produced as a sterile ophthalmic formulation by an EU GMP manufacturer under authorization and quality agreements.
• Distribution: governed by the marketing authorization holder in-country and wholesalers into ophthalmology and retail channels.

What supplier categories matter for due diligence?

• Quality system: EU GMP compliance and sterile/ophthalmic manufacturing experience.
• Change control: container closure system stability and aseptic or sterilized hold-time controls.
• Supply continuity: API sourcing redundancy for ganciclovir.
• Regulatory alignment: whether the manufacturer is named in the EU dossier and can support inspections and DMF/ASMF linkages.

Which company makes ZIRGAN ophthalmic gel (contract manufacturing and finished-goods production)?

Finished-goods manufacture is handled by one or more EU GMP contract manufacturing sites for the ophthalmic gel. Supplier identification for this layer depends on the territory’s regulatory dossier and the specific manufacturing site listed for “manufacturer” and “batch release” in the marketing authorization.

What to look for in regulatory listings

• “Manufacturer” and “Batch release” sites in the European marketing authorization.
• Quality release responsibilities aligned to EU importation or local batch certification.
• Sterile ophthalmic gel specification, including microbial limits, particulate matter, and container compatibility.

Who supplies the active ingredient ganciclovir for ZIRGAN?

Zirgan’s formulation uses ganciclovir. API sourcing typically involves:

• API chemical synthesis suppliers with DMF/ASMF capability (for European markets).
• API distributors/wholesalers moving material into the EU finished-goods manufacturer’s supply chain.

What supplier attributes determine reliability

• Confirmation that ganciclovir grades meet ophthalmic gel specs for impurities and residual solvents.
• Consistency in particle size and polymorphic behavior where applicable.
• Ability to support stability data and change notifications for regulatory filings.

What is the Orange Book status of ZIRGAN and how does that affect supplier landscape?

Orange Book listings apply to the US Hatch-Waxman framework. Zirgan is an ophthalmic product; its US status affects supplier signaling only if it is listed there.

US regulatory status and why it matters for suppliers

• If US-listed, it ties to the US marketing entity and patent/Exclusivity status, which in turn drives:
  • authorized distribution channels
  • generic or alternative sourcing pressure
  • potential Paragraph IV dynamics (not typically the main driver for ophthalmic gels, but relevant if US exclusivity exists)

What patents and exclusivity drive ZIRGAN’s supplier access and contract manufacturing opportunities?

Patent and exclusivity posture affects who can introduce alternatives and whether contract manufacturers can switch clients without regulatory or commercial constraints.

Key questions suppliers will test during onboarding

• Is the formulation still under active IP constraints that limit “authorized generic” or reformulation options?
• Do manufacturing sites require licensing rights for manufacturing know-how?
• Are there data exclusivity constraints for any new route, strength, or dosage form?

Who distributes ZIRGAN in major markets (EU, UK, and other geographies)?

Distribution is typically regional:

• Europe: wholesaler networks into ophthalmology and retail pharmacies, under the authorized marketing authorization holder.
• UK: follows national distribution rules under MHRA governance, typically via wholesalers and major pharma distributors.
• Other markets: distribution is often handled by local importers or regional pharma distributors with tender access.

What procurement teams need from distributors

• Temperature-controlled logistics capability when relevant to gel stability.
• Batch-level traceability and recall readiness.
• Ability to source multi-batch coverage during shortages.

What generic or alternative entry risks exist for ZIRGAN that could change supplier options?

Supplier availability can widen if:

• generics or “drop-in” alternatives enter
• compounding or parallel trade expands materially
• any authorized reformulation is permitted without bridging barriers

What changes the supplier map fastest

• Regulatory approvals that add additional finished-goods manufacturers
• Tender wins that shift distribution contracts
• API supply stabilization that enables more contract manufacturing slots

How strong is the manufacturing and IP barrier for switching ZIRGAN suppliers?

Barriers come from both manufacturing qualification and dossier linkage.

• Manufacturing qualification: line changeover validation, sterile/ophthalmic testing, and container closure system requalification.
• Regulatory linkage: batch release testing frameworks and validated methods.
• IP linkage: if formulation or method-of-use concepts are protected, new entrants may need licensing.

What customers typically face

• longer onboarding timelines for new EU GMP sites
• regulatory agency updates for manufacturer changes
• extended stability studies if container closure or excipients differ

ZIRGAN supplier risk table: where bottlenecks occur

Supply layer	Typical bottleneck	Primary risk to procurement	Mitigations used in practice
ganciclovir API	limited qualified API sources	price volatility, batch nonconformities	dual sourcing and incoming QC tightened
finished ophthalmic gel	limited EU ophthalmic-capable GMP sites	lead-time and batch release delays	pre-qualification of backup sites
distribution	single-country importer dependence	regional shortages and allocation	multi-distributor contracts, safety stock

Key Takeaways

• ZIRGAN supply is built on three supplier layers: ganciclovir API, finished-goods ophthalmic gel manufacturing, and regional distribution under the marketing authorization holder.
• Supplier switching risk is dominated by EU ophthalmic formulation manufacturing qualification and dossier-linked manufacturer and batch release roles.
• Any expansion of supplier options will typically follow regulatory updates that add qualified manufacturing sites or commercial shifts that add additional distributors.

FAQs

1. Is Zirgan manufactured in the EU or outside Europe?
2. Which companies produce ganciclovir API used for ophthalmic antiviral products?
3. How do batch release responsibilities affect who can supply ZIRGAN to distributors?
4. Do changes in container closure systems for ophthalmic gels require regulatory updates for ZIRGAN?
5. What is the fastest way to qualify an alternative supplier for ZIRGAN’s ophthalmic gel manufacturing?

References (APA)

1. FDA Orange Book. (n.d.). Drug Products Listed in the Orange Book. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
2. EMA. (n.d.). European Public Assessment Reports (EPAR) and related regulatory materials. European Medicines Agency. https://www.ema.europa.eu/