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Molecule

Sinecatechins

Available on requestCold chainDermatology
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Sinecatechins is a prescription medicine indicated for the treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older, among other approved uses. It is available as ointment for topical use. MedsAcross supplies Sinecatechins for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

ATC classification
D06BB12 Sinecatechins · Antibiotics and antivirals for the skin, subgroup D06B, subgroup D06BB
US FDA first approval
31 October 2006
EU status
Not recorded
Orphan designation
Not recorded
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Topical
Dosage forms
Ointment
Identifiers
UNII T432289GYZRxCUI 753346CAS 188265-33-0DrugBank DB01266Q20817162

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

Veregen is a topical ointment indicated for the treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older. Limitations of Use Safety and effectiveness of Veregen have not been established in immunosuppressed patients, in treatment of external genital and perianal warts beyond 16-weeks, or for multiple treatment courses.

Source: US FDA prescribing information

How it works

The mode of action of Veregen involved in the clearance of genital and perianal warts is unknown. In vitro, sinecatechins had anti-oxidative activity, the clinical significance of this finding is unknown.

Source: US FDA prescribing information

Dosing overview

• Veregen is to be applied three times per day to all external genital and perianal warts. • Apply about an 0.5 cm strand of ointment to each wart using the finger(s), dabbing it on to ensure complete coverage and leaving a thin layer of the ointment on the warts. • Veregen is not for ophthalmic, oral, intravaginal, or intra-anal use.

Source: US FDA prescribing information

Warnings and precautions

Veregen has not been evaluated for the treatment of urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease and should not be used for the treatment of these conditions. Use of Veregen on open wounds should be avoided. Patients should be advised to avoid exposure of the genital and perianal area to sun/UV-light as Veregen has not been tested under these circumstances. • Veregen should not be used to treat urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease. • Use of Veregen on open wounds should be avoided. • Avoid exposure of Veregen treated areas to sun/UV-light as Veregen has not been tested under these circumstances.

Source: US FDA prescribing information

Side effects

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In Phase 3 clinical trials, a total of 397 subjects received Veregen three times per day topical application for the treatment of external genital and perianal warts for up to 16 weeks. Serious local adverse events of pain and inflammation were reported in two subjects (0.5%), both women. In clinical trials, the incidence of patients with local adverse events leading to discontinuation or dose interruption (reduction) was 5% (19/397).

Source: US FDA prescribing information

Storage

Prior to dispensing to the patient, store refrigerated 2°C to 8°C (36°F to 46°F). After dispensing, store refrigerated or up to 25°C (77°F). Do not freeze.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Sinecatechins, sorted by availability.

MedicineManufacturerRegisterAvailability
Veregen 15% ointmentTopical Cold chainANI PharmaceuticalsUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 31 October 2006Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Sinecatechins available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Sinecatechins and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Sinecatechins have?

The catalogue lists 1 brand names for Sinecatechins, including Veregen.

Is Sinecatechins approved by the US FDA?

Yes. The US FDA first approved Sinecatechins on 31 October 2006, according to Drugs@FDA.

Does Sinecatechins need cold chain shipping?

At least one listed presentation of Sinecatechins must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

Which ATC class is Sinecatechins in?

Sinecatechins is classified under ATC code D06BB12 (Sinecatechins).

References

  1. Veregen prescribing information (ANI Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 10 November 2022

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