Pioglitazone carries a single harmonised EU safety label, but France's 2011 prescribing restriction was only partially lifted in 2013 and still limits new prescriptions today.
Pioglitazone is contraindicated under its harmonised EU label in patients with current or past bladder cancer and unexplained blood in urine, and France's ANSM restriction on new prescriptions, dating to a June 2011 suspension that was only partially lifted in 2013, still applies on top of that label today. M Care supplies pioglitazone oral tablets in 7.5mg, 15mg and 30mg strengths, sourced from WHO-GMP certified Indian manufacturers, across 36 catalogued lines, for regulatory teams who need to register or tender the molecule market by market rather than assume one EU dossier clears every EU desk.
Pioglitazone exporter and bulk supplier from India.
Export documentation for pioglitazone tablets follows M Care's standard oral solid dossier: Certificate of Analysis and Certificate of Pharmaceutical Analysis per batch, stability data, product specification sheets and a Free Sale Certificate where the destination requires one, alongside M Care's own CDSCO export licence and ISO 9001:2015 certificate. Because pioglitazone's market status is not uniform across otherwise similar regulatory blocs, we ask the buyer to confirm current national prescribing or registration status in the destination country before we confirm order, rather than assuming EU or regional harmonisation covers it. Tablets are packed in standard blister or bottle configurations for ambient-temperature road, sea or air freight. Batch traceability documentation is provided for tender and customs clearance on request.
Source
WHO-GMP-certified Indian manufacturing line, named on every quote.
Minimum order
No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.
Pricing
On request. Indicative FOB or CIF quote, formal proforma on confirmation.
Incoterms
EXW, FOB, CIF, CIP or DAP.
Payment
Letter of credit (sight or usance) and telegraphic transfer.
Documentation
WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.
Shelf-life
Minimum remaining shelf-life agreed per order and confirmed on the proforma.
Response
Availability and CoPP status within two working days; pre-alert documents before dispatch.
Thiazolidinedione (TZD), PPAR-gamma agonist, oral antidiabetic, sourced and documented for export.
Pioglitazone has one harmonised EU safety label, but France's ANSM suspended the medicine in June 2011 over a bladder cancer signal and only partially lifted that suspension in 2013: new prescriptions there remain limited to patients without a suitable alternative therapy, a restriction that has never been fully reversed. The EMA's 2011 review kept pioglitazone on the EU market with a contraindication in current or past bladder cancer and in uninvestigated visible haematuria, plus a required prescriber review of treatment benefit at three to six months and periodically after that. Clinically, pioglitazone is a PPAR-gamma agonist used as monotherapy or in combination for type 2 diabetes, valued for durable glycaemic control, and it carries its own fluid-retention and NYHA Class III/IV heart-failure contraindication, separate from the bladder-cancer signal. M Care supplies pioglitazone oral tablets in 7.5mg, 15mg and 30mg, across 36 catalogued lines, all single-ingredient tablets sourced from WHO-GMP certified Indian manufacturers.
Active ingredient
Pioglitazone hydrochloride. Thiazolidinedione (TZD), PPAR-gamma agonist, oral antidiabetic.
Forms and strengths
7.5 mg; 15 mg; 30 mg.
Indications
Pioglitazone is an oral thiazolidinedione insulin-sensitiser used in type 2 diabetes mellitus, as monotherapy or combined with other antidiabetic agents, that improves glycaemic control by increasing peripheral insulin sensitivity via PPAR-gamma activation. Its EU and US labels carry a contraindication in current or history of bladder cancer and in heart failure of NYHA Class III or IV, reflecting regulatory reviews completed in the early 2010s.
Administration
Oral. Tablet.
Documentation
Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.
Hospital pharmacies, licensed importers and tender desks across our export markets.
India is our origin. We do not sell into the Indian market.
M Care's pioglitazone buyers are regulatory affairs teams and licensed importers building or renewing a type 2 diabetes portfolio, hospital and institutional procurement desks running oral antidiabetic tenders, and wholesale distributors restocking an existing pioglitazone line. Demand comes from UK and EU importers running their own national variation checks, Gulf and GCC tender desks, African ministries and distributors sourcing diabetes essentials, Latin American importers, Southeast Asian wholesalers and CIS distributors. We do not sell into India, which is the country of manufacture only. Every enquiry should confirm the destination country's current pioglitazone prescribing status before order, since EU membership alone does not guarantee identical market access.
GCC registration routes
Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.
UK unlicensed routes
Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.
Tender desks
Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.
Dossier support
CTD documentation from the sourcing manufacturer, compiled for your regulator's format.
What the dispensing pharmacist checks on pioglitazone.
A reviewing pharmacist checks the standard pioglitazone contraindications before release paperwork is finalised: current or history of bladder cancer, uninvestigated macroscopic haematuria, and heart failure of NYHA Class III or IV, since the drug's fluid-retention effect can precipitate or worsen cardiac decompensation, particularly in combination with insulin. Liver function is reviewed at baseline given the thiazolidinedione class history, and bone fracture risk in postmenopausal women is flagged as a known class effect distinct from the bladder signal. On the interaction side, pioglitazone is metabolised substantially via CYP2C8: gemfibrozil, a strong CYP2C8 inhibitor, raises pioglitazone exposure roughly threefold, capping the recommended dose at 15mg daily in combination, while rifampicin, a CYP2C8 inducer, can lower pioglitazone exposure by around half, and both are checked against any combination therapy the buyer's market formulary lists. None of this changes what M Care ships, which is the tablet as registered, but it is the checklist a receiving pharmacist runs before a batch clears local release, and buyers should expect it to surface in their own quality review.
The documentation pack a regulator actually asks for.
Each pioglitazone shipment travels with a Certificate of Analysis, Certificate of Pharmaceutical Analysis, batch manufacturing and stability summary, and product specification sheet from the sourcing WHO-GMP certified Indian manufacturer. M Care's own documentation is limited to what it actually holds: ISO 9001:2015 quality management certification and a CDSCO export licence; M Care does not hold and does not claim WHO-GMP or WHO-PQ certification, which sit with the manufacturer, not the exporter. Pioglitazone's regulatory position is not identical across markets that otherwise treat EU authorisation as equivalent: France's own added restriction sits inside an EU-wide label rather than replacing it. We recommend the buyer's regulatory team independently confirm current national prescribing and import status before submitting a registration dossier or tender bid, rather than relying on the harmonised EU label alone. Free Sale Certificates and Certificates of Pharmaceutical Product are arranged on request where the destination authority requires them for registration.
CoA and MoA, per batch
Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.
CoPP, WHO-GMP, MFG licence
Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.
CTD Module 3
Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.
Pack insert, labels, artwork
Destination-language patient information and labelling to the local regulator's standard, locked before shipment.
Pharmacovigilance
A named PV contact arranged in the destination market where the registration requires one.
What a buyer should know before this line enters a formulary.
We publish the awkward facts alongside the useful ones. A supplier who omits them is not saving you work, only deferring it.
Contraindicated in patients with current or a history of bladder cancer
Contraindicated in patients with uninvestigated macroscopic (visible) haematuria
Contraindicated in established NYHA Class III or IV heart failure; caution and a lower starting dose apply in milder heart failure
EU label requires prescriber reassessment of treatment benefit at 3 to 6 months and periodically thereafter
France maintains an additional national prescribing restriction beyond the harmonised EU label, dating to a June 2011 suspension that was only partially lifted in 2013 and never fully reversed
Associated with increased risk of bone fracture, particularly in postmenopausal women
Adjacent lines procurement desks order alongside pioglitazone.
Dapagliflozin metformin
Another diabetes & endocrine line ordered on the same formularies.
Gliclazide
Another diabetes & endocrine line ordered on the same formularies.
Glimepiride
Another diabetes & endocrine line ordered on the same formularies.
All diabetes & endocrine
The full category listing for procurement desks.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form and strength, pack preference, destination market and indicative volume for pioglitazone.
- We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
- Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
- Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
- After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Pioglitazone supply, the specific questions.
Does pioglitazone's EU-wide marketing authorisation mean it is prescribed the same way in every member state?
No. The EMA's 2011 review kept pioglitazone on the market across the EU under one harmonised label, but France's ANSM suspended the medicine that same year and only partially lifted the suspension in 2013. New prescriptions in France remain limited to patients without a suitable alternative therapy, a restriction that has never been fully reversed. Buyers should confirm current national prescribing status in each destination country rather than assume EU authorisation is applied uniformly.
What contraindications does a receiving pharmacist screen for before releasing a pioglitazone batch?
Pioglitazone is contraindicated in patients with current or a history of bladder cancer and in patients with uninvestigated macroscopic (visible) blood in the urine, following a 2011 EU and US regulatory review that found a small increased risk of bladder cancer with longer term, higher cumulative dose use. These are the two screening checks a prescriber runs before initiating or continuing treatment. M Care does not provide dosing or clinical-use advice; this is stated for regulatory reference only.
How often does the EU label require a prescriber to reassess a patient's continued use of pioglitazone?
The harmonised EU label requires prescribers to review the benefit of treatment at three to six months after starting pioglitazone, and periodically afterwards, to confirm that only patients deriving sufficient benefit continue on it. This requirement sits alongside the bladder cancer contraindications and is part of why several EU markets treat pioglitazone as a reviewed therapy rather than an open-ended one.
Is pioglitazone appropriate for patients with heart failure?
Pioglitazone is contraindicated in patients with established NYHA Class III or IV heart failure, because its fluid retention effect can precipitate or worsen cardiac decompensation. In milder heart failure the label limits the starting dose and advises caution, particularly in combination with insulin. This is a prescribing decision for the buyer's own clinical and regulatory teams, not a claim M Care makes about the product's use.
Does M Care supply pioglitazone and metformin fixed-dose combination tablets?
No. All 36 of M Care's pioglitazone lines are single-ingredient pioglitazone tablets. Pioglitazone-metformin fixed-dose combinations are a separate product with their own registration and are not part of the current catalogue. Buyers who need the combination should raise that requirement separately, since it is sourced and documented independently of plain pioglitazone.
Does M Care hold WHO-GMP or WHO-PQ certification directly?
No. M Care is a merchant exporter, not a manufacturer, so it does not hold WHO-GMP or WHO-PQ certification itself. M Care sources pioglitazone tablets from WHO-GMP certified Indian manufacturers and holds its own ISO 9001:2015 quality management certification and a CDSCO export licence.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-08-22.
This page is sourcing information for licensed importers, hospital procurement and tender desks. It is not medical, pharmaceutical or prescribing advice, and it is not a substitute for the approved product information of the line on your order. See our full disclaimer.
Send the specifics. You'll have a price inside one working day.
Form and strength, destination market and indicative volume. The Mumbai desk replies within one working day, including when the honest answer is that the route is not viable yet.