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Tunodafil

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Ready to proceed? Start a request for Tunodafil on our secure patient portal to submit your prescription, upload documents and track your approval status.

Tunodafil

Supplied with complete CDSCO-approved import and customs documentation, including Form 12A & 12B, CDEC, GST Bill of Entry, Commercial Invoice, and Packing List.

Medicine Name: Tunodafil
Generic Name (API): Tunodafil Hydrochloride
Dosage Form & Strength: 50 mg
Route: Oral
Drug Class: Phosphodiesterase type 5 (PDE5) inhibitor

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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What Is Tunodafil Used For?

Tunodafil is a tablet for erectile dysfunction (ED), the ongoing difficulty in getting or keeping an erection firm enough for sex. It was developed in China by Yangtze River Pharmaceutical Group, where it is sold as 泰妥妥® (Taituotuo). Its Chinese name is 盐酸妥诺达非片 (tunodafil hydrochloride tablets), and in earlier research it was called youkenafil.

China's National Medical Products Administration (NMPA) approved it in July 2025 (approval number 国药准字H20250052) for:

  • The treatment of erectile dysfunction in men

The company launched it across China in June 2026. It is a prescription medicine listed in our other therapeutic areas section, and should be prescribed by a urologist, andrologist or physician after a proper check-up.

How It Works

During sexual arousal the body releases a messenger called cGMP, which relaxes the blood vessels in the penis so blood can flow in. An enzyme called PDE5 breaks cGMP down. Tunodafil is a selective PDE5 inhibitor: it slows that breakdown, so the natural response to arousal is stronger and lasts longer. It does not cause an erection without sexual stimulation.

What the Trial Showed

The phase 3 trial, presented at the World Meeting on Sexual Medicine in 2026, included 780 men in China aged 18 to 65. They took 50 mg or 100 mg when needed, or a placebo, for 12 weeks, and 93.2% completed the study. On the standard erectile function score (IIEF-EF), scores improved by 9.5 points with 50 mg and 10.8 points with 100 mg, against 6.7 with placebo. By the end, 52.4% of men on 50 mg and 61.0% on 100 mg had reached the normal range (a score of 26 or more). Satisfaction with intercourse, orgasm and desire also improved compared with placebo.

Recommended Dosage

In the phase 3 trial:

  • One tablet (50 mg or 100 mg) was taken about 1 hour before sexual activity, only when needed
  • No more than one dose was taken in 24 hours

In China it is supplied as 50 mg tablets. Your doctor will confirm the dose from the Chinese prescribing information.

This information is not a treatment plan. For personalized medical advice, consult your doctor and refer to the full prescribing information.

Warnings and Precautions

Nitrate heart medicines: as a group, PDE5 inhibitors are not used together with nitrates, because the combination can cause a sudden, dangerous drop in blood pressure. Tell your doctor if you take or carry any nitrate medicine for chest pain, and ask about any heart condition before starting.

  • Common side effects: in the phase 3 trial, the side effects seen in at least 2% of men were dizziness, headache, flushing, palpitations, dry mouth, a stuffy nose and raised liver enzymes (ALT or AST). Most were mild, passed on their own, and no serious side effects were reported.
  • Some HIV and antifungal medicines: a strong blocker of the liver enzyme CYP3A4, used in HIV treatment, raised tunodafil levels about 78-fold in a study, and the authors concluded the two must not be combined. Tell your doctor about every medicine you take.
  • Alcohol: drinking alcohol with it raised tunodafil levels by about 43% and increased the heart rate more than either alone. The fall in blood pressure came mainly from the alcohol. Keep alcohol moderate.
  • Other medicines: it mildly affects how some acid-reducing medicines are broken down. Give your doctor a full list of what you take.
  • Long-term use: the company reports that a 12-month study showed good long-term safety and tolerability with on-demand use.

ED can be an early sign of heart disease, diabetes or hormone problems, so a check-up before treatment is worthwhile. The trial included men up to 65, and this medicine is for adult men only.

How to Access Tunodafil in India: A 6-Step Process

Step 1 – Search & request your medicine: The patient or treating doctor submits a request with basic details to initiate the access process.

Step 2 – Verification & eligibility review: The team verifies availability and reviews eligibility against regulatory and clinical requirements to ensure a compliant pathway.

Step 3 – Receive quote & delivery timeline: A transparent quotation is shared, covering medicine cost, logistics, and a clear delivery timeline.

Step 4 – Regulatory approval process: Assistance is provided to secure the approvals and documentation required for legal cross-border access.

Step 5 – Temperature-controlled import & handling: The medicine is sourced and transported under strict GDP-compliant conditions to maintain product integrity.

Step 6 – Secure delivery: The medicine is delivered to the patient or treating hospital, with updates provided at each stage.

Note: From request to delivery, every step is designed to ensure your treatment reaches you safely, compliantly, and without unnecessary delays.

Documentation & Availability

What documents are required to import Tunodafil to India?

The tablets can be imported only in the patient's name, in line with India's import regulations for unapproved medicines. You will need:

  • A valid prescription from a qualified urologist, andrologist or physician
  • A short medical summary, including any heart condition and current medicines
  • Patient ID proof (issued by the Government of India)

How is the order confirmed?

Once we have received and checked a valid prescription and, where needed, an import permit.

Is Tunodafil available in India?

No. It is approved only in China. It has no CDSCO approval, it is not sold in Indian pharmacies, and the US FDA and European Medicines Agency have not approved it either.

Patients can still get it legally through the Named Patient Program (NPP), which allows a medicine not registered in India to be imported for one specific patient on a prescription. For men with Peyronie's disease, a condition that causes a curved erection, see our page on Xiaflex.

It can be made available to patients, doctors, and hospitals across major cities in India, including Gurgaon, Delhi, Bangalore, Mumbai, Navi Mumbai, Thane, Hyderabad, Mysore, Kerala, Chennai, Coimbatore, Madurai, Kolkata, Ahmedabad, Surat, Vadodara, Pune, Nagpur, Nashik, Jaipur, Udaipur, Lucknow, Kanpur, Gorakhpur, Chandigarh, Mohali, Faridabad, Noida, Ghaziabad, Kochi, Trivandrum, Kozhikode, Thrissur, Kannur, Mangalore, Bhubaneswar, Patna, Ranchi, Raipur, Guwahati, Visakhapatnam, Vijayawada, Goa, Jammu, Srinagar, Dehradun, Bhopal, Indore, Ludhiana, Amritsar, and others — and can facilitate delivery to the patient's treating hospital. Orders are confirmed only after receipt of a valid doctor's prescription and an import permit, where applicable.

Sourcing & Delivery

NamedPatientProgram.com (NPP) sources this medicine through the manufacturer's authorised supply channels in China and arranges supply to patients and doctors under applicable legal provisions. In China each box holds a single 50 mg tablet, so we order the number of boxes the prescription covers. The tablets are stored as directed on the pack and travel in their sealed original boxes under temperature-controlled shipping, in plain, discreet packaging. All prescriptions are dispensed and checked by registered pharmacists and dispatched from New Delhi, India, after legal requirements are fulfilled.

For the current cost in India and availability, contact NPP via WhatsApp at +91 98104 69557 | Toll-Free: 1800-1200-365 or email info@namedpatientprogram.com.

Availability Across Major Cities in India

Patients across India can access this medicine through regulated import pathways, with discreet delivery arranged to the patient or clinic on a valid doctor's prescription.

Delhi

Men's health clinics in Delhi can request the tablets for a named patient, and our New Delhi dispatch point means a short wait.

Mumbai

Urologists in Mumbai can share the prescription with us, and the tablets are delivered privately to the patient.

Bangalore

Patients in Bangalore receive a written quote first, and nothing is ordered until they agree.

Chennai

Patients across Tamil Nadu can use the same documented import route, with updates shared at each step.

Hyderabad

We deliver in plain packaging to the home or clinic address the patient chooses.

Kolkata

Patients from Kolkata and the eastern states can receive the tablets without travelling.

Pune

Andrologists in Pune can coordinate access for patients who need this specific medicine.

Ahmedabad

The treating doctor can send us the prescription and medical summary to start the import.

Jaipur

Patients in Rajasthan can have the tablets delivered home, as long as the import is in their own name.

Chandigarh

Serves patients from Punjab, Haryana and Himachal Pradesh, with delivery to home or clinic.

Lucknow

We coordinate delivery for patients seen at urology clinics across Uttar Pradesh.

Kochi

Patients across Kerala can receive the tablets at home in Kochi and nearby cities.

Access can also be coordinated for patients in other Indian cities, subject to a valid prescription and regulatory requirements.

Author Details

Nitin Goswami

Written By

Nitin Goswami

Deputy Manager – Content & Social Media, Ikris Pharma Network

Sources: NMPA • CDSCO

Dr. Chirag C Shah

Medically Reviewed By

Dr. Chirag C Shah

MBBS

Last Updated: 19 October 2026

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