Xenical (orlistat) is licensed for obesity management with a reduced-calorie diet, and an FDA-authorised generic orlistat 120mg capsule now sits alongside the originator brand.
Xenical (orlistat), originated by Roche, is a reversible gastrointestinal lipase inhibitor used with a reduced-calorie diet for weight loss, weight maintenance and reducing the risk of weight regain. M Care Exports is a merchant exporter: we source Xenical and FDA-authorised generic orlistat 120mg capsules through licensed Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.
Orlistat exporter and bulk supplier from India.
Orlistat is an oral solid dose, so tender quotes are built around pack format and strength mix rather than reconstitution kit or infusion set. M Care quotes the 120mg prescription-strength capsule against buyer specification, brand Xenical or the licensed generic, and confirms destination-market OTC-versus-prescription classification before pack artwork is finalised, since the same molecule sells as a 60mg over-the-counter pack (Alli) in some markets and as a 120mg prescription-only line in others. CTD or eCTD dossier support and batch-specific certificates of analysis accompany every shipment.
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.
Gastrointestinal lipase inhibitor, sourced and documented for export.
Orlistat is a reversible inhibitor of gastrointestinal lipases. It binds the active site of gastric and pancreatic lipase, blocking the enzyme from breaking down roughly 30 percent of dietary triglycerides, which then pass through the gut unabsorbed rather than being taken up as calories.
Its FDA-labelled indication is obesity management, including weight loss, weight maintenance, and reducing the risk of weight regain after prior weight loss, used together with a reduced-calorie, reduced-fat diet. It is not an appetite suppressant and has no central nervous system activity, which distinguishes its counselling needs from newer GLP-1 agents.
Orlistat is supplied as a 120mg capsule for prescription use (Xenical strength) and a 60mg capsule for over-the-counter use in markets where that classification applies (marketed as Alli). It is a solid oral dosage form, stored at controlled room temperature, and needs no cold chain.
Active ingredient
orlistat. Gastrointestinal lipase inhibitor.
Forms and strengths
60 mg capsule; 120 mg capsule.
Indications
Reversible inhibitor of gastric and pancreatic lipase indicated for obesity management, including weight loss, weight maintenance and reducing the risk of weight regain, used with a reduced-calorie diet.
Administration
oral. Capsule.
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.
Buyers for orlistat include hospital and clinic pharmacies running weight-management or bariatric-medicine services, MoH tender desks procuring for national non-communicable disease (NCD) and diabetes-prevention programmes, licensed pharmaceutical wholesalers and importers stocking a metabolic or endocrine range, and retail pharmacy chains sourcing the OTC 60mg pack where local regulation permits over-the-counter sale. Because GLP-1 agonists now dominate premium weight-management budgets, orlistat increasingly sits in tenders as the lower-cost oral option a formulary keeps alongside them.
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 orlistat.
Orlistat is dosed at one 120mg capsule three times daily with each main meal containing fat, taken during the meal or up to an hour after it; a dose can be skipped if a meal is missed or contains no fat, since there is nothing for the drug to act on. Counsel patients on a reduced-calorie diet of roughly 30 percent fat, spread evenly across meals, to limit the gastrointestinal effects (oily spotting, flatulence, urgency) that drive early discontinuation. A multivitamin containing fat-soluble vitamins A, D, E and K should be taken at least two hours apart from orlistat, since absorption of these vitamins is reduced alongside dietary fat. Orlistat is contraindicated in pregnancy, chronic malabsorption syndrome and cholestasis. Rare cases of severe liver injury, including hepatic failure, have been reported, and oxalate nephropathy has occurred in patients with reduced renal function, so a baseline renal history is worth flagging at dispensing. Cyclosporine should be dosed three hours apart from orlistat, and levothyroxine at least four hours apart, with thyroid function monitored. No cold-chain handling is required.
The documentation pack a regulator actually asks for.
As an oral solid, orlistat ships on standard ambient-temperature logistics rather than the validated cold-chain lanes M Care runs for biologics. What buyers need instead is clarity on OTC-versus-prescription classification per destination market, since the same active ingredient is sold both ways depending on strength and local scheduling, plus the usual batch-level certificate of analysis, CDSCO export documentation and CTD or eCTD dossier support where the destination regulator requires local registration.
On brand versus generic: Xenical is the originator brand, first developed by Roche; the current DailyMed filing lists Cheplapharm as the trademark holder, with Xenical and the FDA-authorised generic orlistat 120mg capsule both distributed in the US under H2-Pharma's label. This is a genuine brand-or-generic choice for a tender desk, and M Care quotes either against the buyer's specification.
Orlistat is not among the medicines WHO added to its Essential Medicines List in the 2025 update; that update added GLP-1 receptor agonists (semaglutide, liraglutide, dulaglutide) and tirzepatide for diabetes with obesity or cardiovascular and renal comorbidity. Orlistat's role in most formularies now sits alongside those newer agents as the lower-cost oral option, not as a WHO-EML-listed line itself.
The paperwork above is the molecule-specific part; the general pathway a destination regulator expects is set out in our licensed import route guide.
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.
Adjacent lines procurement desks order alongside orlistat.
Dapagliflozin
Another diabetes & endocrine line ordered on the same formularies.
Dapagliflozin metformin
Another diabetes & endocrine line ordered on the same formularies.
Dulaglutide
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 orlistat.
- 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.
Orlistat supply, the specific questions.
Does a generic version of Xenical exist?
Yes. An FDA-authorised generic orlistat 120mg capsule is marketed in the US by H2-Pharma under licence from Cheplapharm, alongside the originator brand Xenical. M Care quotes either against a tender's brand-or-generic specification, checking registration status in the destination market first.
Can M Care supply Xenical to our market?
Yes, on an import basis. We source Xenical through licensed Indian distribution channels and dispatch against your import authorisation and destination-market OTC-versus-prescription classification, which we confirm before packing the order.
What strengths of orlistat are available?
120mg capsules for prescription-strength use, matching the Xenical dose, and 60mg capsules for over-the-counter sale in markets where that classification applies. Tell us your market's regulatory route and we quote the correct strength.
Does orlistat need cold-chain shipping?
No. Orlistat is an oral capsule stored at controlled room temperature, so it moves on standard ambient logistics rather than the validated cold-chain lanes used for biologics and vaccines.
What documentation does M Care provide with an orlistat shipment?
A batch-specific certificate of analysis, CDSCO export paperwork from the Indian side, and CTD or eCTD-aligned dossier documentation where the destination regulator requires local registration before import.
What is orlistat licensed to treat?
Its FDA-labelled indication is obesity management, including weight loss, weight maintenance and reducing the risk of weight regain, used together with a reduced-calorie diet. It works by blocking dietary fat absorption in the gut rather than suppressing appetite.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-11.
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.