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

Zyprexa (olanzapine) is licensed for schizophrenia and bipolar mania across tablet, orodispersible and short-acting intramuscular formats, and FDA and MHRA-approved generic olanzapine is available alongside the originator brand.

M Care Exports is a merchant exporter of Zyprexa (olanzapine), originated by Eli Lilly, an oral atypical antipsychotic used for schizophrenia and bipolar mania and, as a short-acting intramuscular injection, for acute agitation. We source the originator brand and FDA and MHRA-approved generic olanzapine through licensed 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

Olanzapine exporter and bulk supplier from India.

For hospital psychiatry units, wholesalers and tender desks, M Care quotes olanzapine against buyer specification: brand (Zyprexa) or generic, tablet, orodispersible or short-acting IM format, strength mix (2.5 mg to 20 mg) and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because olanzapine carries a boxed warning restricting its use in elderly dementia-related psychosis, we confirm the buyer's intended patient population 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

Atypical (thienobenzodiazepine) antipsychotic, sourced and documented for export.

Olanzapine is an atypical (thienobenzodiazepine) antipsychotic with combined dopamine and serotonin receptor antagonism, giving broad efficacy in psychotic and mood symptoms with a lower extrapyramidal burden than older typical agents. Zyprexa's flagship licensed indications are schizophrenia and acute or maintenance treatment of bipolar I mania, alone or with lithium or valproate; a short-acting intramuscular formulation is separately licensed for rapid control of agitation in schizophrenia or bipolar mania when oral therapy is not appropriate. It is dosed orally once daily, with no reconstitution needed for tablets, though the IM vial requires reconstitution before injection. Zyprexa is supplied as coated tablets in 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg strengths, plus orodispersible tablets (5 mg, 10 mg, 15 mg, 20 mg) for patients with swallowing difficulty, and a 10 mg vial for short-acting IM injection.

Active ingredient

Olanzapine. Atypical (thienobenzodiazepine) antipsychotic.

Forms and strengths

2.5 mg coated tablet; 5 mg coated tablet; 5 mg orodispersible tablet; 7.5 mg coated tablet; 10 mg coated tablet; 10 mg orodispersible tablet; 10 mg powder for solution for injection, vial; 15 mg coated tablet; 15 mg orodispersible tablet; 20 mg coated tablet; 20 mg orodispersible tablet.

Indications

Olanzapine, marketed as Zyprexa, is an atypical antipsychotic indicated for schizophrenia and bipolar I mania, with a short-acting intramuscular form for acute agitation. Supplied as originator Zyprexa and licensed generic tablets from Indian WHO-GMP facilities to regulated and semi-regulated markets outside India.

Administration

Oral, Intramuscular. Coated tablet, orodispersible tablet and powder for solution for injection.

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 olanzapine are mainly hospital and community mental-health pharmacists managing schizophrenia and bipolar disorder caseloads, psychiatric hospital and secure-unit procurement teams needing the short-acting IM format for acute agitation, national and regional MoH tender desks running mental-health formulary lists, licensed pharmaceutical wholesalers and importers, and NGO or public-health programmes supporting severe mental illness treatment access in markets where local registration is in place.

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 olanzapine.

Olanzapine dosing starts low and titrates by indication: schizophrenia typically starts at 5 to 10 mg once daily targeting 10 mg, while bipolar mania monotherapy often starts higher, at 10 to 15 mg once daily; debilitated patients and those predisposed to hypotension or slower metabolism should start at 5 mg. The short-acting IM formulation requires reconstitution immediately before use and is not interchangeable with the separate long-acting depot product (olanzapine pamoate), which carries its own post-injection delirium/sedation syndrome monitoring requirement and is not part of this line. Orodispersible tablets disperse on the tongue or in liquid and are bioequivalent to coated tablets, useful where swallowing or concealment is a concern. Olanzapine carries a boxed warning: elderly patients with dementia-related psychosis treated with antipsychotics face increased mortality, and Zyprexa is not approved for that population. Metabolic monitoring, weight, glucose and lipids, is recommended at baseline and periodically, since olanzapine carries a comparatively higher weight-gain and dyslipidaemia signal among atypical antipsychotics. No cold-chain handling is required; tablets store at standard ambient conditions, protected from light and moisture.

Regulatory & quality

The documentation pack a regulator actually asks for.

As oral tablets, orodispersible tablets and a short-acting IM vial, olanzapine travels on standard ambient-temperature logistics, protected from light and moisture, rather than the cold-chain lanes M Care validates for biologics and insulins. Olanzapine was added to the WHO Model List of Essential Medicines in 2023 for schizophrenia or other primary psychotic disorders, listed as a therapeutic alternative to risperidone. On the brand-versus-generic question, buyers genuinely have a choice: Zyprexa, originated by Eli Lilly, remains the reference brand in the US and UK, while FDA and MHRA-approved generic olanzapine tablets from multiple manufacturers are separately registered and widely available in the US, UK and EU. A national UK supply shortage of the long-acting depot product (Zypadhera) was reported in 2023, so M Care confirms current lot and formulation availability with the sourcing partner before quoting. Because Zyprexa is prescribed under mandatory safety information covering elderly dementia-related psychosis risk, we confirm the buyer's intended patient population and formulary use before dispatch.

Permit sequence, registration status and customs handling are documented in importing medicines from India through the licensed route; this page sticks to what is specific to the molecule.

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 olanzapine.
  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

Olanzapine supply, the specific questions.

Does a generic version of Zyprexa exist?

Yes. FDA and MHRA-approved generic olanzapine tablets and orodispersible tablets are registered and widely marketed in the US, UK and EU alongside the originator brand Zyprexa. Registration status varies by destination country, so M Care checks local approval before quoting brand or generic against a specific tender.

Can M Care supply Zyprexa to our market?

Yes, on an import basis. We source Zyprexa through licensed Indian distribution channels and dispatch against your import authorisation and any local registration your pharmacy, hospital or wholesaler holds.

What strengths and formats of olanzapine does M Care source?

Coated tablets in 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg, orodispersible tablets in 5 mg, 10 mg, 15 mg and 20 mg for patients with swallowing difficulty, and a 10 mg vial for short-acting intramuscular injection. Tell us your indication mix and dosing protocol and we quote the strength and format split accordingly.

Why does olanzapine carry a boxed warning, and does that affect supply?

Olanzapine carries a boxed warning because elderly patients with dementia-related psychosis treated with antipsychotic drugs face an increased risk of death, and Zyprexa is not approved for that population. This is a clinical prescribing restriction rather than a supply constraint, but M Care confirms the buyer's intended patient population before a first dispatch as part of standard due diligence.

Is the short-acting intramuscular olanzapine the same as the long-acting depot injection?

No. The short-acting IM formulation, a 10 mg vial reconstituted immediately before use, is licensed for rapid control of agitation and is a separate product from the long-acting depot injection (olanzapine pamoate), which is dosed monthly and carries its own post-injection delirium and sedation monitoring requirement. M Care's olanzapine line covers the tablet, orodispersible tablet and short-acting IM formats; buyers should specify which format a tender line requires.

Is olanzapine on the WHO Essential Medicines List?

Yes. Olanzapine was added to the WHO Model List of Essential Medicines in 2023 for schizophrenia or other primary psychotic disorders, as a therapeutic alternative to risperidone. This supports its use on public-sector formularies and MoH tender lists across our export markets.

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 2026-09-19.

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.

Olanzapine enquiry

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.

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