WHO-GMP sourced EU-GMP partners ISO 9001:2015 49+ export markets Since 2003

Tamiflu (oseltamivir) is licensed for the treatment and post-exposure prevention of influenza A and B, and buyers can specify the Roche brand or a licensed generic oseltamivir capsule against the same tender line.

Tamiflu (oseltamivir), originated by Roche, is an oral neuraminidase inhibitor that hospital pharmacies and national stockpile programmes rely on for influenza treatment and post-exposure prophylaxis, particularly during winter surge periods when demand spikes within days. M Care Exports is a merchant exporter: we source Tamiflu and FDA- and MHRA-licensed generic oseltamivir capsules through Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.

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WHO-GMP sourcing CDSCO licensed exporter EU-GMP capable partners Cold-chain validated (2–8°C & −25°C) CTD / eCTD dossier-ready ISO 9001:2015
Bulk supply and export terms

Oseltamivir exporter and bulk supplier from India.

For hospital, wholesaler and tender-desk orders, M Care quotes oseltamivir against buyer specification: brand (Tamiflu) or generic, strength mix (30 mg, 45 mg, 75 mg capsules or oral suspension powder) and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because seasonal influenza demand can move a tender from routine to urgent within a single week, we confirm lead time and pack-size flexibility against the buyer's ordering window before dispatch, then align CTD/eCTD or country-specific dossier paperwork to the destination regulator's requirements.

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.

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At a glance

Neuraminidase inhibitor antiviral, sourced and documented for export.

Oseltamivir is a prodrug neuraminidase inhibitor: once absorbed and hydrolysed to its active carboxylate form, it blocks the viral enzyme influenza A and B strains need to release new virions from infected cells. That mechanism is why timing matters more than with most antivirals on this roster. Tamiflu's flagship licensed use is treatment of acute, uncomplicated influenza in patients who have been symptomatic for no more than 48 hours, plus post-exposure prophylaxis of influenza A or B; destination-country labelling can extend the prophylaxis population and setting further, so buyers should check the specific licensed age ranges and prophylaxis criteria on their own market's approved label. It is an oral, non-injectable therapy supplied as hard capsules (30 mg, 45 mg, 75 mg) and as a powder that pharmacists reconstitute into a 6 mg/mL oral suspension for patients who cannot swallow capsules, most often children and older adults.

Active ingredient

Oseltamivir phosphate. Neuraminidase inhibitor antiviral.

Forms and strengths

30 mg capsule; 45 mg capsule; 75 mg capsule; 6 mg/mL oral suspension, reconstituted.

Indications

Oseltamivir, a prodrug neuraminidase inhibitor marketed originally as Tamiflu, is licensed for the treatment and post-exposure prophylaxis of influenza A and B. Supplied from Indian WHO-GMP facilities as brand or licensed generic to regulated and semi-regulated markets.

Administration

Oral. Capsule and powder for oral suspension.

Documentation

Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.

Who we supply

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 oseltamivir are hospital and community pharmacists ordering ahead of the winter influenza season, MoH tender desks running national pandemic-preparedness and seasonal-stockpile lines, licensed importers and wholesalers who need to fill orders quickly once local case counts rise, and NGO or public-health procurement teams supporting outbreak response in markets where seasonal supply chains are thin. Because demand for oseltamivir is seasonal and can surge abruptly rather than following a flat annual run rate, buyers on this molecule tend to prioritise confirmed lead time and pack-size flexibility as much as unit price.

GCC registration routes

Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.

MoH registration, GCC →

UK unlicensed routes

Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.

MHRA Specials →

Tender desks

Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.

Tender response →

Dossier support

CTD documentation from the sourcing manufacturer, compiled for your regulator's format.

Dossier preparation →

Pharmacist's note

What the dispensing pharmacist checks on oseltamivir.

Oseltamivir only works if it is started early: the licensed treatment indication is for patients symptomatic no more than 48 hours, and prophylaxis dosing (75 mg once daily) is a different regimen from treatment dosing (75 mg twice daily for five days), so confirm which one a tender line actually specifies. Renal function changes both dose and interval, not just dose: adults with creatinine clearance 30 to 60 mL/min are stepped down to 30 mg, and patients on haemodialysis or peritoneal dialysis need a different schedule again, so flag renal-adjustment protocols to the receiving unit rather than assuming standard dosing applies. The reconstituted 6 mg/mL suspension is stable for 17 days refrigerated or 10 days at room temperature, which matters for community dispensing where patients take the bottle home. Watch for neuropsychiatric symptoms, chiefly in paediatric patients, and for rare but serious skin reactions including Stevens-Johnson syndrome; both are flagged in the approved label as reasons to stop therapy and review.

Regulatory & quality

The documentation pack a regulator actually asks for.

Oseltamivir capsules and oral suspension powder are an oral solid or oral powder dosage form, so they travel on standard ambient, moisture-controlled logistics rather than the validated cold-chain lanes M Care runs for biologics and injectable oncology lines. Oseltamivir has sat on the WHO Model List of Essential Medicines since 2011 as an antiviral for influenza, which is one reason MoH tender desks in Africa and the GCC carry it as a standing preparedness line rather than an ad-hoc order. On the brand-versus-generic question, Tamiflu remains the originator product from Roche. Licensed generic oseltamivir phosphate capsules are separately registered and marketed in both the US (multiple ANDA holders since 2016, including Natco Pharma) and the UK (ADVANZ Pharma oseltamivir 30 mg, 45 mg and 75 mg capsules alongside Roche's Tamiflu on the electronic medicines compendium), so buyers genuinely have a brand-or-generic choice on formulary. Oseltamivir is not a controlled substance in any of M Care's served markets, which keeps import paperwork to standard prescription-only-medicine documentation rather than narcotics licensing.

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.

How the enquiry works

Molecule · strength · volume · destination. One working day to a quote.

  1. Send us the specifics. Form and strength, pack preference, destination market and indicative volume for oseltamivir.
  2. We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
  3. Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
  4. Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
  5. After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Frequently asked

Oseltamivir supply, the specific questions.

What is oseltamivir licensed to treat?

Oseltamivir is licensed for two related but distinct uses. As treatment, it is indicated for acute, uncomplicated influenza A or B in patients who have been symptomatic for no more than 48 hours. As prophylaxis, it is indicated for post-exposure prevention of influenza A or B. Check the specific licensed age ranges and prophylaxis criteria on your destination market's approved label, as these vary by regulator.

Can Tamiflu and generic oseltamivir be supplied against the same tender?

Yes, where the tender specifies the molecule rather than the brand. Tamiflu is Roche's originator product; licensed generic oseltamivir phosphate capsules are separately registered and marketed in the US and UK alongside it. M Care confirms whether a given tender or formulary line calls for the named brand or accepts a licensed generic before quoting, so buyers get whichever the paperwork actually requires.

Does oseltamivir dosing change for patients with reduced kidney function?

Yes, and the change is significant. Adults with creatinine clearance between 30 and 60 mL/min are stepped down to a lower dose for both treatment and prophylaxis, and patients on haemodialysis or peritoneal dialysis follow a different schedule again tied to their dialysis cycle. Buyers supplying renal or dialysis units should confirm which dosing protocol the receiving pharmacy is working to.

How long is the reconstituted oral suspension stable for?

Once the powder is reconstituted into the 6 mg/mL oral suspension, it is stable for 17 days if kept refrigerated at 2 to 8 degrees Celsius, or 10 days if kept at room temperature. This is relevant for community and take-home dispensing, where the reconstituted bottle travels home with the patient rather than staying in a controlled pharmacy environment.

Does oseltamivir need cold-chain shipping?

No. Oseltamivir capsules and the unreconstituted oral suspension powder are stored at standard controlled room temperature and shipped on ambient, moisture-controlled logistics, not the validated cold-chain lanes M Care runs for biologics and certain injectable oncology lines. Cold-chain only becomes relevant after a pharmacist reconstitutes the suspension for dispensing.

Why does oseltamivir supply need faster lead times than other molecules on this list?

Influenza demand is seasonal and can surge within days of a local case-count rise, rather than following a flat annual order pattern. National stockpile and MoH tender desks in the GCC and Africa often hold oseltamivir as a standing preparedness line for exactly this reason. M Care confirms lead time and pack-size flexibility against the buyer's ordering window up front, since a slow quote on this molecule can miss the window it was needed for.

Is oseltamivir a controlled substance?

No. Oseltamivir is a prescription-only neuraminidase inhibitor antiviral and is not scheduled as a controlled substance in any of M Care's served markets. Import documentation follows standard prescription-only-medicine requirements rather than narcotics or psychotropic licensing.

Sources and review

Who stands behind this page, and where its statements come from.

Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-13.

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.

Oseltamivir enquiry

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