Doxofylline, licensed regionally as Ansimar through Italy's ABC Farmaceutici, is a xanthine bronchodilator for asthma, COPD and chronic bronchitis that needs no blood-level monitoring, and generic doxofylline tablets and syrup now sit alongside it on many formularies.
Doxofylline is an oral xanthine-derivative bronchodilator, licensed across parts of Asia including the Philippines as Ansimar under Italy's ABC Farmaceutici, alongside widely available generic doxofylline tablets and syrup. M Care Exports is a merchant exporter: we source generic doxofylline tablets and syrup through licensed Indian manufacturing channels and dispatch on quote, not from our own manufacturing. Ansimar remains the region's recognised originator brand, licensed and manufactured through its own regional channel rather than the M Care roster.
Doxofylline exporter and bulk supplier from India.
For hospital pharmacy, wholesaler and MoH tender-desk orders, M Care quotes generic doxofylline against buyer specification: 200mg or 400mg tablets or 100mg/5mL oral syrup, drawn from licensed Indian WHO-GMP manufacturer lines on the M Care roster, plus destination-market regulatory documentation. The originator brand Ansimar is licensed and manufactured through its own regional channel outside India; where a tender specifies Ansimar by name, M Care confirms current availability separately before quoting. Because doxofylline is not FDA, MHRA or EMA-authorised and registration status varies market to market, we confirm the buyer's own import or registration pathway first, then align CTD/eCTD or country-specific dossier paperwork to what the destination regulator actually asks for.
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.
Xanthine-derivative bronchodilator; phosphodiesterase (PDE3/PDE4) inhibitor, sourced and documented for export.
Doxofylline is a xanthine-derivative bronchodilator that inhibits phosphodiesterase enzymes (chiefly PDE3 and PDE4), raising intracellular cyclic AMP and relaxing bronchial smooth muscle. Unlike theophylline, it has little affinity for adenosine A1 and A2 receptors and does not meaningfully interact with the CYP1A2, CYP2E1 or CYP3A4 cytochrome pathways, which is the basis for its narrower side-effect profile and the reason prescribers do not routinely order therapeutic drug-level monitoring for it. It is dosed orally only, with no reconstitution step. Adults typically take 400mg twice daily, reduced to 200mg two or three times daily in elderly patients or those with cardiovascular, hepatic, renal or gastric comorbidity; children aged six to twelve take an oral syrup rather than a tablet. Doxofylline is supplied as 200mg and 400mg tablets and a 100mg/5mL oral syrup.
Active ingredient
Doxofylline. Xanthine-derivative bronchodilator; phosphodiesterase (PDE3/PDE4) inhibitor.
Forms and strengths
200 mg tablet; 400 mg tablet; 100 mg/5mL oral syrup.
Indications
Doxofylline, a xanthine-derivative bronchodilator indicated for bronchial asthma, COPD and chronic bronchitis, distinguished from theophylline by low adenosine-receptor affinity and minimal cytochrome P450 interaction. M Care supplies generic doxofylline tablets and syrup from Indian WHO-GMP facilities to regulated and semi-regulated markets outside India; the originator brand Ansimar is licensed from Italy's ABC Farmaceutici and manufactured separately for regional distribution in Asia.
Administration
Oral. Tablet; oral syrup.
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 doxofylline are hospital respiratory-medicine and paediatric pharmacies managing asthma, COPD and chronic bronchitis patients, community and outpatient formularies stocking a xanthine bronchodilator alternative to theophylline, national and regional MoH tender desks running respiratory and NCD procurement lists, and licensed pharmaceutical wholesalers and importers across our GCC and African markets seeking a bronchodilator that avoids theophylline's monitoring burden and drug-interaction load.
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 doxofylline.
Doxofylline's dosing splits by age and risk profile: standard adult dosing is 400mg twice daily, stepped down to 200mg two to three times daily in elderly patients and those with cardiovascular, hepatic, renal or gastric disease, where clearance is more likely to be reduced. Children aged six to twelve are dosed by weight with the 100mg/5mL syrup per the destination label rather than with a fraction of the adult tablet; use under six years is not established, so dispensing should stop at the counter for younger children. Roughly three-quarters of reported adverse events are gastrointestinal (nausea, epigastric discomfort), and unlike theophylline, doxofylline does not require routine blood-level monitoring because of its low adenosine-receptor affinity and minimal cytochrome P450 interaction, an advantage worth flagging when a formulary is weighing xanthine options. Use with caution in patients with a history of peptic ulcer or seizure disorder, and avoid in acute myocardial infarction or hypotension. Human pregnancy data are limited, so xanthines including doxofylline should be used only where clearly needed, and the drug is distributed into breast milk, so caution is warranted in lactation. No cold-chain handling or reconstitution is required; tablets and syrup both store at controlled room temperature.
The documentation pack a regulator actually asks for.
As an oral solid and oral liquid dosage form, doxofylline travels on standard ambient-temperature logistics rather than the validated cold-chain lanes M Care runs for biologics. What buyers need instead is batch-level certificate of analysis, CDSCO export documentation and, where the destination market requires it, CTD or eCTD-format dossier support so the buyer's own regulator can register the product. Doxofylline does not hold FDA, MHRA or EMA marketing authorisation; it received FDA orphan-drug designation for bronchiectasis in 2014, which is a development incentive, not a marketing approval, and it is not licensed in the UK. It does not appear on the WHO Model List of Essential Medicines; theophylline and aminophylline are the xanthine bronchodilators WHO lists for asthma, so tender desks should treat doxofylline as a formulary-specific alternative rather than an EML first-line agent. The originator brand, Ansimar, is licensed from Italy's ABC Farmaceutici and manufactured under that licence for regional distribution in Asia, including the Philippines; buyers in those markets should check current local registration status before specifying the brand by name. Generic doxofylline tablets and syrup from multiple manufacturers, including the WHO-GMP manufacturers on M Care's sourcing roster, are widely available as the interchangeable alternative.
Buyers new to sourcing from India usually read the licensed import route explainer first, then the product page.
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 doxofylline.
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 doxofylline.
- 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.
Doxofylline supply, the specific questions.
Does a generic version of doxofylline exist alongside Ansimar?
Yes. Generic doxofylline tablets and oral syrup from multiple manufacturers are widely available alongside the originator brand Ansimar, licensed from Italy's ABC Farmaceutici and manufactured regionally in Asia. M Care supplies the generic line from WHO-GMP manufacturers on its sourcing roster and can advise on Ansimar's separate regional availability where a tender names the brand specifically.
Is doxofylline FDA or MHRA approved?
No. Doxofylline does not hold FDA, MHRA or EMA marketing authorisation. The FDA granted it orphan-drug designation for bronchiectasis in 2014, a development incentive rather than a marketing approval, and it is not a licensed medicine in the UK or EU. Buyers in those regulated markets should confirm their own import or unlicensed-medicine pathway before ordering.
What strengths of doxofylline are available?
200mg and 400mg tablets, and a 100mg/5mL oral syrup for children and patients who cannot take a solid dose form. Tell us your indication mix and patient age range and we quote the strength split accordingly.
Why choose doxofylline over theophylline for some patients?
Doxofylline has low affinity for adenosine A1 and A2 receptors and minimal interaction with cytochrome P450 enzymes, which is why it carries fewer cardiac and CNS side effects than theophylline and, unlike theophylline, does not require routine therapeutic drug-level monitoring. It is not on the WHO Essential Medicines List, so formularies typically stock it as a specific alternative rather than a first-line xanthine.
Can children take doxofylline?
Doxofylline syrup is used in children aged six to twelve, dosed by weight per the destination label rather than as a fraction of the adult tablet. Use under six years is not established in standard product labelling, so dispensing should stop at the counter for younger children pending prescriber confirmation.
What documentation does M Care provide with a doxofylline shipment?
Batch-level certificate of analysis, CDSCO export documentation from the Indian side, and CTD/eCTD-aligned dossier support where the destination regulator requires local registration. Because doxofylline lacks FDA, MHRA or EMA authorisation, we also confirm the buyer's own import licence or unlicensed-medicine route before dispatch.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-14.
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.
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