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Fotagliptin

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

Fotagliptin

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: Fotagliptin
Generic Name (API): Fotagliptin Benzoate
Dosage Form & Strength: 6 mg, 12 mg
Route: Oral
Drug Class: Dipeptidyl peptidase-4 (DPP-4) inhibitor

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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    Temperature-controlled logistics ensuring safe, reliable, and timely medicine delivery.

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What Is Fotagliptin Used For?

Fotagliptin is a once-a-day tablet for type 2 diabetes, developed in China by Shenzhen Salubris Pharmaceuticals, where it is sold as 信立汀® (Xinliting). It helps the body make better use of its own blood-sugar hormones, so sugar levels come down after meals and between them.

China's National Medical Products Administration (NMPA) approved it on 28 June 2024 as a Class 1 innovative drug, to improve blood sugar control in adults with type 2 diabetes:

  • On its own, alongside diet and exercise
  • Together with metformin, when metformin alone is not keeping blood sugar under control

It is a prescription diabetes and hormone medicine and should be used under an endocrinologist, diabetologist or physician.

How It Works

After a meal, the gut releases two hormones, GLP-1 and GIP, that tell the pancreas to release insulin and hold back glucagon, the hormone that raises sugar. An enzyme called DPP-4 breaks these hormones down within minutes. Fotagliptin blocks DPP-4, so the hormones last longer. Because they work only when blood sugar is raised, insulin is released in a glucose-dependent way, which is why low sugar episodes were uncommon in the trial.

What the Trial Showed

The phase 3 trial, published in BMC Medicine in 2023, enrolled 458 adults in China whose type 2 diabetes was not controlled by diet and exercise. After 24 weeks, HbA1c fell by 0.70% with fotagliptin against 0.26% with placebo, a difference of 0.44%. 37.0% of people on fotagliptin reached an HbA1c below 7.0%, compared with 15.5% on placebo. It worked as well as an established comparison medicine of the same class (HbA1c fall of 0.72%), and body weight stayed within 1 kg over 52 weeks.

Recommended Dosage

  • The tablets are approved in two strengths, 6 mg and 12 mg
  • In the phase 3 trial the dose was 12 mg, taken by mouth once a day
  • It can be used alone or with metformin, as your doctor decides

The full Chinese prescribing information sets out the approved dose and any changes needed for kidney or liver problems, so your doctor will confirm the plan before you start.

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

Warnings and Precautions

Only for type 2 diabetes: it is approved for adults with type 2 diabetes. It is not a treatment for type 1 diabetes or for diabetic ketoacidosis.

  • Low blood sugar: on its own it rarely caused low sugar. In the 24-week trial, hypoglycaemia occurred in 0.9% of people on fotagliptin and 6.2% on placebo. The risk can be higher if it is combined with insulin or with tablets that push the pancreas to release insulin, so tell your doctor about all your diabetes medicines.
  • Blood fats: abnormal blood fat levels were the most common finding (12.3%), but this was seen just as often with placebo (13.3%).
  • Uric acid: raised uric acid was reported in 7.9% of people on fotagliptin against 2.7% on placebo. People with gout should mention it to their doctor.
  • Pancreas enzyme: a rise in lipase, an enzyme made by the pancreas, was seen in 3.5% of patients (1.8% on placebo). Report severe, lasting stomach pain straight away.
  • Infections: upper respiratory tract infections (6.1%) and urinary tract infections (5.7%) occurred at similar rates to placebo.

Overall: side effects were mostly mild in the trial, with no deaths and no serious side effect affecting more than 2% of any group. Safety in pregnancy, breastfeeding and children has not been established in the published data, so discuss this with your doctor first. As with any new medicine, your doctor should read the full Chinese prescribing information for the complete list of warnings and interactions.

How to Access Fotagliptin 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 Fotagliptin to India?

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

  • A valid prescription from a qualified endocrinologist, diabetologist or physician
  • Recent reports confirming type 2 diabetes, such as HbA1c and fasting blood sugar, with a list of current diabetes 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 Fotagliptin 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.

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, doctors, and hospitals under applicable legal provisions. Because diabetes treatment is long term, we can plan supply in blocks of several months so there is no gap between orders. The tablets travel in their sealed original packs under temperature-controlled shipping and should be stored as directed on the pack. 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 delivery arranged to the patient or the treating clinic on a valid doctor's prescription.

Delhi

Diabetes clinics in Delhi see patients from across North India, and being close to our New Delhi dispatch point keeps delivery times short.

Mumbai

Endocrinologists in Mumbai can request the tablets for a named patient, with a supply plan that matches the follow-up schedule.

Bangalore

Patients in Bangalore can have the medicine delivered to their home or clinic once the prescription and reports are checked.

Chennai

With many diabetes specialists in the city, doctors here can send us the prescription and HbA1c report to start the process.

Hyderabad

We help patients in Hyderabad set up repeat orders so that daily treatment continues without breaks.

Kolkata

Deliveries to Kolkata and the eastern states are planned so the next pack arrives before the current one runs out.

Pune

Patients in Pune can use the same documented import route, with updates shared at every step.

Ahmedabad

Gujarat has a large number of people living with diabetes, and physicians in Ahmedabad can coordinate access for a named patient.

Chandigarh

Serves patients from Punjab, Haryana and Himachal Pradesh, with delivery to the patient or the treating clinic.

Jaipur

Patients across Rajasthan can receive the tablets at home, as long as the import is in their own name.

Lucknow

We coordinate delivery for patients treated at public and private diabetes clinics across Uttar Pradesh.

Kochi

Kerala has one of the highest rates of diabetes in India, and patients in Kochi and nearby cities can have supplies delivered locally.

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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