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Retagliptin and Metformin

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Retagliptin and Metformin

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: Retagliptin and Metformin
Generic Name (API): Retagliptin Phosphate + Metformin Hydrochloride (fixed-dose combination)
Dosage Form & Strength: 50 mg/850 mg, 50 mg/1000 mg
Route: Oral
Drug Class: DPP-4 inhibitor + biguanide (fixed-dose combination)

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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What Is Retagliptin and Metformin Used For?

Retagliptin and metformin is a two-in-one diabetes tablet developed in China by Jiangsu Hengrui Pharmaceuticals, with Shandong Shengdi Pharmaceutical as the licence holder. The 50 mg/850 mg strength is sold as 瑞霖唐® (Ruilintang). Each tablet combines retagliptin, a DPP-4 inhibitor developed in China, with metformin, the long-established first-line diabetes medicine, so patients take one tablet instead of two.

China's National Medical Products Administration (NMPA) approved it in May 2025 for:

  • Adults with type 2 diabetes who are suitable for treatment with both retagliptin phosphate and metformin hydrochloride, to improve blood sugar control

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

How It Works

The two medicines tackle high blood sugar in different ways. Retagliptin blocks the DPP-4 enzyme, so the body's own GLP-1 hormone stays active for longer and the pancreas releases more insulin, and less glucagon, when sugar is high. Metformin, a biguanide, lowers the amount of sugar the liver releases and helps the body respond better to insulin. The tablet is made in two layers, so each medicine is kept separate and released on its own.

What the Trials Showed

In the phase 3 HR-SP2086-303 trial, 371 adults whose diabetes was not controlled on metformin alone added either retagliptin 50 mg twice a day or a placebo. After 24 weeks, average HbA1c fell by 1.18% from where it started, 0.62% more than with placebo. 40.5% reached an HbA1c below 7%, against 20.5% on placebo, and there were no severe low-sugar episodes. A bioequivalence study then showed that the combined tablet delivers the same amount of each medicine to the blood as taking retagliptin and metformin tablets separately.

Recommended Dosage

  • One tablet twice a day, morning and evening, after meals
  • The starting strength is chosen from the treatment the patient is already on
  • The total daily dose must not go above 100 mg of retagliptin and 2,000 mg of metformin
  • Two strengths: 50 mg retagliptin with 850 mg metformin (I), and 50 mg retagliptin with 1,000 mg metformin (II)

Your doctor will pick the strength and check kidney function before and during treatment.

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

Warnings and Precautions

Metformin and lactic acidosis: metformin can rarely cause lactic acidosis, a dangerous build-up of acid in the blood. The US metformin label lists the main risk factors as kidney impairment, age 65 or over, X-ray scans with contrast dye, surgery, severe heart failure or low oxygen states, heavy alcohol use and liver impairment. Metformin is not used when eGFR is below 30, and it is usually paused around contrast scans and surgery. Seek urgent help for unexplained fast breathing, muscle pain, unusual tiredness or sleepiness, or stomach pain.

  • Kidney function: both medicines depend on the kidneys, so a kidney test is needed before starting and regularly afterwards.
  • Low blood sugar: no severe hypoglycaemia was seen in the phase 3 trial, and non-severe episodes occurred in 2.4% of patients on retagliptin with metformin. Tell your doctor about any other diabetes medicines you take.
  • Pancreas and skin: pancreatitis and serious skin reactions are adverse events watched for with all DPP-4 inhibitors. None was seen in the trial, but seek medical help for severe, lasting stomach pain or a blistering rash.
  • Vitamin B12: long-term metformin can lower vitamin B12, so the US label advises checking it every 2 to 3 years.
  • Liver: retagliptin has not been studied in people with liver impairment.

Side effects in the trial: the only side effect seen in at least 1% of patients taking retagliptin with metformin was raised uric acid (1.3%). No serious side effects were linked to treatment, and the combined tablet did not add side effects compared with taking the two medicines separately. Safety in pregnancy, breastfeeding and children has not been established in the published data, so discuss this with your doctor first.

How to Access Retagliptin and Metformin 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 Retagliptin and Metformin 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, stating the strength (50/850 or 50/1000)
  • Recent reports, including HbA1c, fasting blood sugar and a kidney function test (creatinine or eGFR)
  • 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 Retagliptin and Metformin available in India?

No. This combination is approved only in China. It has no CDSCO approval, it is not sold in Indian pharmacies, and neither it nor retagliptin on its own has been approved by the US FDA or the European Medicines Agency.

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. Because diabetes treatment is long term, your doctor will plan supply in regular batches.

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. At one tablet twice a day, a month of treatment needs about 60 tablets, and we order the exact strength written on the prescription. 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 specialists in Delhi see patients from all over North India, and our New Delhi dispatch point keeps delivery quick.

Mumbai

Doctors in Mumbai can request the right strength for a named patient and set up repeat batches so treatment never runs out.

Bangalore

Patients in Bangalore can have the tablets sent home once the prescription and kidney report are checked.

Chennai

Diabetologists in Chennai can share the prescription and recent HbA1c with us to start the import.

Hyderabad

Endocrinologists in Hyderabad can coordinate access, with the quote shared in writing before any order is placed.

Kolkata

For Kolkata and the eastern states, we time each batch so the next arrives before the current one is finished.

Pune

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

Ahmedabad

Physicians in Ahmedabad can arrange supply for patients who would benefit from one combined tablet.

Jaipur

Patients in Jaipur and across Rajasthan can receive the tablets at home or at their clinic.

Chandigarh

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

Lucknow

We coordinate deliveries to patients and hospitals across Uttar Pradesh after the documents are complete.

Kochi

Patients across Kerala can receive the medicine 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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