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Simenafil

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

Simenafil

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: Simenafil
Generic Name (API): Simenafil Hydrochloride
Dosage Form & Strength: 2.5 mg, 5 mg, 10 mg
Route: Oral
Drug Class: Phosphodiesterase type 5 (PDE5) inhibitor

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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  • Temperature-Controlled Logistics for Safe and Timely Delivery

    Temperature-controlled logistics ensuring safe, reliable, and timely medicine delivery.

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What Is Simenafil Used For?

Simenafil 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 Vigonvita Life Sciences together with the Shanghai Institute of Materia Medica of the Chinese Academy of Sciences, and was known in research as TPN171. In China it is sold as 昂伟达® (simenafil hydrochloride tablets, 盐酸司美那非片).

China's National Medical Products Administration (NMPA) approved it on 8 July 2025 for:

  • The treatment of erectile dysfunction in men

The company reports an earlier approval in Uzbekistan in 2022, where it is sold as Onvita®. It is a prescription medicine listed in our other therapeutic areas section, and it 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. Simenafil is a highly selective PDE5 inhibitor: it slows that breakdown, so the natural response to arousal lasts longer. It does not cause an erection without sexual stimulation. According to the company, it acts on PDE5 far more than on related enzymes linked with eye and muscle side effects.

What the Trial Showed

The phase 3 trial, published in The Journal of Sexual Medicine in 2025, included 765 men aged 18 to 75 in China, most with moderate to severe ED. They took 2.5 mg, 5 mg or 10 mg when needed, or a placebo, for 12 weeks. On the standard erectile function score (IIEF-EF, where 26 or more counts as normal), scores rose by 12.3, 12.3 and 12.7 points with the three doses, against 9.6 points with placebo (all P < .001). The company reports that average scores reached 25.6 to 26.1, close to the normal range. 92.3% of the men completed the study.

Recommended Dosage

  • Taken by mouth only when needed, before sexual activity
  • The trial authors describe 5 mg as the clinically recommended dose; tablets also come as 2.5 mg and 10 mg
  • The company reports that it starts working within 30 minutes and has a half-life of 8 to 11 hours
  • For men with mild or moderate liver problems, a pharmacokinetic study recommends no more than 5 mg

Your doctor will confirm the dose and how often it can be taken 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, side effects related to the tablet occurred in 36.2% of men on simenafil (32.6% at 5 mg) and 30.9% on placebo. The most frequent were dizziness, headache, flushing, a stuffy nose and dry mouth, mostly mild or moderate. Headache was reported in 2.6% to 3.7%, depending on the dose.
  • Eyes and muscles: no abnormal vision or muscle pain was reported with simenafil in that trial.
  • Other medicines: strong CYP3A4 blockers (some antifungals and HIV medicines) raised exposure almost threefold, and strong enzyme inducers (some tuberculosis and epilepsy medicines) cut it by about 90%. The study authors advise avoiding these combinations or adjusting the dose.
  • Liver and kidneys: blood levels are higher with liver problems, so the dose is capped at 5 mg in mild to moderate liver impairment. A kidney study found it can be used with caution in mild to severe kidney impairment.
  • Alcohol: alcohol did not change how the body handles simenafil, but taking both together raised the pulse rate more than either alone. Keep alcohol moderate.

ED can be an early sign of heart disease, diabetes or hormone problems, so a check-up before treatment is worthwhile. This medicine is for adult men only.

How to Access Simenafil 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 Simenafil 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 Simenafil available in India?

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

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. The tablets are stored as directed on the pack and travel in their sealed original boxes under temperature-controlled shipping, in plain, discreet packaging. In China the 5 mg strength comes in boxes of 7 tablets, the 2.5 mg in boxes of 2 and the 10 mg as a single tablet. 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

Urology and andrology clinics in Delhi can request the tablets for a named patient, and our New Delhi dispatch point keeps delivery quick.

Mumbai

Patients in Mumbai can have the tablets delivered privately to their home once the prescription is checked.

Bangalore

Doctors in Bangalore can share the prescription with us, and the quote is sent before anything is ordered.

Chennai

Patients across Chennai and Tamil Nadu can use the same documented import route, with updates at every step.

Hyderabad

We deliver in discreet packaging to the address the patient chooses.

Kolkata

Patients from Kolkata and the eastern states can receive the tablets without needing to travel.

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 begin 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 treated 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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