Suppliers and packagers for podofilox

podofilox

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Padagis Us	PODOFILOX	podofilox	GEL;TOPICAL	211871	ANDA	Padagis US LLC	0574-0621-05	3.5 g in 1 TUBE, WITH APPLICATOR (0574-0621-05)	2023-12-13
Padagis Us	PODOFILOX	podofilox	SOLUTION;TOPICAL	075600	ANDA	Padagis US LLC	0574-0611-05	1 BOTTLE, GLASS in 1 CARTON (0574-0611-05) / 3.5 mL in 1 BOTTLE, GLASS	2002-01-29

Suppliers for Podofilox (Podophyllotoxin)

Last updated: April 26, 2026

Podofilox is a topical antimitotic used for external genital warts (condyloma acuminata). It is sold as a prescription topical solution or gel under brand names in several markets and is also produced as a generic. Supply chains typically split between (1) API (podophyllotoxin) producers and (2) finished-dose manufacturers that formulate and package podofilox products for local/regional registration.

Which companies supply Podofilox products (finished-dose)?

Below are commonly listed commercial suppliers/manufacturers for podofilox finished dosage forms in key markets (solution/gel/cream presentations). Presence on regulatory and distribution pathways is what matters for procurement.

Market / Product form	Supplier / Manufacturer	What they supply	Evidence
EU (general topical products supply ecosystem)	Multiple MAH/brand and generic manufacturers	Podofilox topical formulations	EU product listings for podofilox-containing products
US (NDA/RLD ecosystem)	Multiple generic manufacturers	Podofilox topical solution	FDA Orange Book listings (active ingredient podofilox)
UK (medicine distribution ecosystem)	Multiple MAH/importers	Podofilox topical products	UK MHRA / product databases and wholesaler catalog listings

No single global “sole supplier” exists for podofilox finished products because formulations and packaging are handled through multiple market authorizations and generic manufacturing sites.

Which companies supply the Podofilox API (podophyllotoxin)?

Podofilox active ingredient is podophyllotoxin (or podophyllotoxin-based conversion to podofilox in specific routes depending on the chemistry package used by the manufacturer). API supply is concentrated among fine-chemical and API-grade manufacturers.

Supplier / Manufacturer	Supply role	Typical implication for buyers	Evidence
Global fine-chemical and API makers	API (podophyllotoxin)	Used by finished-dose manufacturers for podofilox formulations	Regulatory and chemical catalog supplier ecosystems
Contract manufacturing networks	API and/or intermediates	Formulators source API from approved or qualified suppliers	Standard API supply practices for specialty oncology/antimitotic actives

API manufacturing is often done by a small number of specialty chemical manufacturers; finished-dose products then rely on those API sources plus contract formulation and packaging.

What supplier qualification and procurement checkpoints matter for Podofilox?

Because podofilox is a cytotoxic antimitotic and regulated as an Rx topical, qualification typically focuses on GMP status and regulatory compliance.

Core procurement checkpoints

• Finished-dose: marketing authorization holder (MAH) or equivalent accountable entity, plus GMP manufacturing site for the dosage form and batch release testing.
• API: GMP for API manufacturing, impurity profile control, and traceability from podophyllotoxin starting material through the API process.
• Regulatory coverage: availability of CoA, DMF (where applicable), CEP/EDMF/ASN documentation (EU), and Orange Book or equivalent references (US).

Documentation buyers should require

• Certificate of Analysis (CoA) per lot for API and finished product
• Specifications for strength, impurities, identity, and stability
• GMP certificates for manufacturing sites involved in API and finished-dose manufacture
• Evidence of regulatory status for the marketed dosage form in the target jurisdiction

How do buyers usually structure Podofilox sourcing?

Podofilox sourcing is typically structured into two procurement lanes:

1. Direct finished-dose supply

   • Buyer orders the marketed product from distributors or MAH-led supply chains.
   • Best fit for short lead times, straightforward local compliance, and predictable packaging.

2. API-first route (for internal formulation or contract formulation)

   • Buyer qualifies an API manufacturer and then contracts with a finished-dose manufacturer.
   • Best fit for scale, cost control, and custom packaging/strength needs.

Risk controls

• Ensure the finished-dose manufacturer’s formulation method is aligned with the exact API grade and impurity profile delivered.
• Verify stability program data supports shelf life for the specific container-closure system.
• Confirm labeling compliance for the target country (Rx classification, strength units, and indication language).

What are the key product specs that suppliers commonly align to?

Podofilox products are usually supplied as topical solutions/gel with standardized strength and delivery system requirements.

Spec category	Typical supplier alignment	Procurement impact
Strength (dosage form)	Defined mg/mL or % formulation by marketed product	Prevents dose variability across batches
Purity/impurities	API impurity limits tied to validated process	Avoids out-of-spec finished product batches
Stability	Shelf life supported by accelerated/real-time programs	Impacts order planning and inventory
Micro/chemical controls	Dosage-form-specific testing	Controls quality release criteria

Key Takeaways

• Podofilox supply is split between API producers (podophyllotoxin) for upstream sourcing and finished-dose manufacturers/MAHs for downstream distribution.
• Procurement success depends less on finding a single “supplier of Podofilox” and more on qualifying GMP manufacturing sites, API impurity control, and regulatory-market authorization for the exact dosage form.
• Buyers should run sourcing through two lanes: direct finished-dose procurement for speed or API-first qualification for scale and formulation control.

FAQs

1. Is there one global supplier for Podofilox?
   No. Finished-dose products and API supply are handled through multiple manufacturers and market authorizations.

2. Who supplies Podofilox: API manufacturers or finished-dose companies?
   Both. API suppliers provide podophyllotoxin (upstream), while finished-dose manufacturers formulate and package podofilox topical products (downstream).

3. What is the main qualification focus for Podofilox sourcing?
   GMP compliance, impurity specifications, and regulatory-market authorization for the marketed dosage form.

4. Can a finished-dose manufacturer source from any podophyllotoxin API supplier?
   Not without qualification. The finished product must match the API grade, impurity profile, and validated formulation method.

5. What documents should be required from Podofilox suppliers?
   Lot CoAs, GMP certificates, full specifications, and stability support for shelf life, plus regulatory evidence for the target market dosage form.

References

[1] U.S. Food and Drug Administration (FDA). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
[2] European Medicines Agency (EMA). Medicines product information and related regulatory records (search portal for podofilox). https://www.ema.europa.eu/en/medicines
[3] UK Medicines and Healthcare products Regulatory Agency (MHRA). Medicines information and regulatory records (search for podofilox-containing products). https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency