REVATIO: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Viatris	REVATIO	sildenafil citrate	SOLUTION;INTRAVENOUS	022473	NDA	Viatris Specialty LLC	58151-395-31	1 VIAL in 1 CARTON (58151-395-31) / 12.5 mL in 1 VIAL	2025-04-09
Viatris	REVATIO	sildenafil citrate	TABLET;ORAL	021845	NDA	PFIZER LABORATORIES DIV PFIZER INC	0069-4190-68	90 TABLET, FILM COATED in 1 BOTTLE (0069-4190-68)	2005-06-03
Viatris	REVATIO	sildenafil citrate	TABLET;ORAL	021845	NDA AUTHORIZED GENERIC	Aphena Pharma Solutions - Tennessee, LLC	43353-345-10	10 TABLET, FILM COATED in 1 BOTTLE (43353-345-10)	2012-09-27
Viatris	REVATIO	sildenafil citrate	TABLET;ORAL	021845	NDA AUTHORIZED GENERIC	Aphena Pharma Solutions - Tennessee, LLC	43353-345-20	20 TABLET, FILM COATED in 1 BOTTLE (43353-345-20)	2012-09-27
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: April 25, 2026

Who Supplies Revatio (sildenafil) and What Inputs Matter?

Revatio is the brand of sildenafil for pulmonary arterial hypertension (PAH), marketed in multiple dosage forms (notably oral tablets and oral suspension in many markets). “Suppliers” in pharma typically breaks into three operational buckets that determine availability and manufacturing continuity:

Marketing authorization holders / brand owners
Drug substance (API) and excipient sourcing for manufacturing
Contract manufacturing and packaging (CMO/CDMO) and fill-finish partners

This brief maps the supplier ecosystem for Revatio as far as it can be identified from publicly available, patent- and registration-linked materials, and it flags what is knowable versus what is not determinable from the available record.

Who holds Revatio’s rights in key geographies?

Revatio is a Pfizer brand in most major markets for PAH (sildenafil). The brand-level supplier designation therefore starts with Pfizer as the business owner directing quality, regulatory submissions, and supply chain requirements.

Brand owner (marketing authorization holder):

Pfizer (global brand holder for Revatio in most jurisdictions)

Why this matters for “supplier” due diligence

API and finished dosage form manufacturing is typically contracted, but the MAH controls release specifications, pharmacovigilance, and batch disposition. In practice, “supplier” responsibilities for supply continuity and lifecycle management flow through the MAH’s quality system, even when manufacturing is outsourced.

What are the typical upstream “supplier” inputs for Revatio manufacturing?

Revatio tablets and oral suspension require a standard set of upstream suppliers for:

Sildenafil drug substance (API)
Excipients (formulation-dependent)
Packaging materials (bottles, blisters, cartons, leaflets)
Analytical reference standards and stability program materials
GMP contract manufacturing for bulk production and final dosage assembly

Drug substance (API) supplier profile

For branded sildenafil products, the API supply chain is usually diversified across:

Multiple API manufacturers supplying sildenafil citrate (or sildenafil API with downstream salt formation depending on process)
Multiple finished-dose manufacturers executing tablet/suspension manufacturing under Pfizer’s quality system

Practical consequence for investors and R&D

A Revatio supply risk assessment should treat API and fill-finish capacity as independent chokepoints. If API is constrained, finished-dose production may pause despite packaging capacity.

Excipients and formulation supply

Excipients are generally supplied by specialty chemical firms and large excipient formulators. For Revatio oral suspension, excipient supply tends to include:

Suspending agents
Buffering agents
Sweeteners and flavor systems
Viscosity modifiers and preservatives
Purified water and solvent systems used in granulation or suspension manufacturing (process dependent)

Because excipient supplier lists are not uniformly published at the product level, the only defensible approach is to rely on registration dossiers and facility disclosures. Those data are often jurisdiction-specific and not consolidated in a single public source.

Which contract manufacturers typically touch sildenafil PAH products?

Revatio’s finished dosage manufacturing is commonly performed by CMOs/CDMOs under commercial manufacturing agreements. Public identification of specific CMO names is inconsistent across jurisdictions because:

Facility identities can be omitted from marketing materials
Supplier disclosure differs by regulatory authority and application type
Different strength presentations can be manufactured by different sites

What can be stated without overstating

Revatio involves Pfizer-directed manufacturing controls.
Finished dosage supply usually uses contract manufacturing capacity.
Site-specific CMO names for every market are not consistently available in a single public record.

What does the patent landscape imply about supplier choices?

Patent status affects supplier behavior most strongly through:

Authorized manufacturing during exclusivity
Regulatory strategy for generics and authorized generics
API availability and process know-how transfer

For sildenafil PAH products, supplier networks are shaped by the fact that sildenafil is a mature molecule with multiple manufacturing routes and global commercial supply. That maturity tends to produce:

Multi-sourcing for API
Competitive pricing among API suppliers
Expanded availability of fill-finish and packaging vendors

Revatio “supplier” checklist for due diligence

For business teams assessing supply resilience, the actionable supplier universe to map is:

MAH / brand owner
- Pfizer (Revatio brand)
API sites
- Identify approved sildenafil API manufacturers per jurisdiction and per strength form (tablets vs suspension)
Finished dose manufacturing sites
- Identify approved manufacturing and release sites per regulatory jurisdiction
Quality and batch release
- Confirm which party performs QP release disposition (EU context) and which local affiliate handles release
Packaging and labeling vendors
- Identify packaging artwork and printing qualification flows and bottle/blister material suppliers where relevant
Cold chain is not generally a driver
- Revatio is not typically a cold-chain product; logistics risks are more about GMP capacity, temperature excursions, and shelf-life management

Key Takeaways

Pfizer is the Revatio brand owner and the primary commercial supplier in the sense that it directs manufacturing, regulatory compliance, and batch release under its quality system.
Upstream “supplier” coverage for sildenafil is commonly multi-sourced, spanning sildenafil API producers, formulation excipient vendors, and CMO/CDMO fill-finish manufacturers, with site lists varying by jurisdiction.
A complete supplier map for Revatio requires jurisdiction-level dossier review for approved API and finished-dose manufacturing sites; those lists are not consistently consolidated in a single public disclosure.
For PAH supply resilience work, treat API capacity and finished-dose fill-finish capacity as separate risk nodes.

FAQs

1) Is Revatio manufactured by Pfizer or contract manufacturers?

Revatio manufacturing is typically executed through contract manufacturing capacity under Pfizer-controlled specifications and release processes, with site responsibility varying by market and presentation.

2) Who supplies the sildenafil active ingredient used in Revatio?

Revatio uses sildenafil API (often handled as sildenafil citrate depending on process). Multiple GMP API manufacturers generally supply commercial sildenafil products, but the exact approved supplier list depends on jurisdiction and dossier approvals.

3) Do tablet and oral suspension versions have the same suppliers?

Not necessarily. Different strengths and dosage forms often use different manufacturing and fill-finish sites, even within the same brand supply chain.

4) How do patents affect Revatio supply sourcing?

Patents influence authorized manufacturing and competitive entry timing, which affects how suppliers qualify and scale. With sildenafil’s maturity, supplier ecosystems tend to be multi-sourced once competitive manufacturing paths exist.

5) Where can Revatio supplier lists be confirmed for a specific market?

Supplier confirmation is usually done through the regulatory product dossier and local approval documentation for that jurisdiction, where approved manufacturing sites and sometimes key supply chain controls are listed.

References (APA)

[1] Pfizer. (n.d.). Revatio (sildenafil) prescribing information / product information (country-specific). Pfizer.
[2] European Medicines Agency. (n.d.). EPAR / product information for sildenafil (Revatio) where available (jurisdiction-specific). EMA.
[3] U.S. Food and Drug Administration. (n.d.). Drug approval and product labeling records for Revatio (sildenafil). FDA.

Suppliers and packagers for REVATIO

REVATIO