Bortezomib injection — supplier from India to the UK, GCC and Africa.
A proteasome inhibitor for multiple myeloma and mantle cell lymphoma. 2mg and 3.5mg lyophilised vials from Indian WHO-GMP facilities, with the CTD dossier, batch documentation and cold-chain controls a regulated-market buyer expects.
29 manufacturer lines · 2mg and 3.5mg vials · full CTD dossier on file.
Active ingredient
Bortezomib (N-[(1R)-1-[[(2R)-3-methyl-1-[[(1R)-1-methylpropyl]amino]-1-oxo-2-butanyl]amino]-3-methyl-1-oxo-2-butanyl] pyrazinecarboxamide). Boronic-acid proteasome inhibitor, targeting the 26S proteasome's chymotrypsin-like activity.
Strengths stocked
2mg vial and 3.5mg vial, lyophilised powder for reconstitution. Approved intravenous and subcutaneous administration, as per destination-country labelling.
Indications
First-line and relapsed multiple myeloma; mantle cell lymphoma. Combination regimens (VRd, VCd, VMP) are common in hospital purchasing; we supply the bortezomib component only.
Storage
Unopened vials: 2-8°C, protected from light. Reconstituted solution: use within 8 hours. Cold-chain validated transit to destination, with temperature logs issued on arrival.
Shelf life
24 months from manufacture on the powder form; minimum 18 months at the point of dispatch to you, or we won't ship it.
Pack format
Single vial per carton, hospital pack. Shippers built to IATA PI 650 for air freight; validated passive cold-chain to 72 hours minimum.
Hospital pharmacies, importers and tender desks across twelve markets.
India is our origin. We do not sell into the Indian market. Bortezomib is exported only.
United Kingdom
Hospital pharmacies and specialist importers under the MHRA Specials / named-patient import route. Where an unlicensed medicine import is needed for an individual patient, we prepare the MHRA Special form documentation pack on the manufacturer side.
GCC (UAE, KSA, Kuwait, Oman, Qatar, Bahrain)
Through local licensed importers, against MoH tender awards and hospital pharmacy purchase orders. CTD dossiers prepared for national MoH registration and GCC central registration.
Nigeria, Kenya, Ghana, South Africa
Public-sector tenders (NHIS, KEMSA, CMS, provincial procurement) and teaching-hospital supply. WHO-PQ pathway supported where the tender specifies it. NGO and global-health-fund buyers catered for separately.
Germany
Supply via licensed German importers under §72 AMG, with Qualified Person (QP) certification on arrival. CTD dossier and CoPP prepared for BfArM recognition.
The documentation pack a regulator actually asks for.
Our role is manufacturer-facing. We sit between the Indian WHO-GMP facility and your clinical, regulatory or procurement team and take the paperwork off both sides.
CTD Module 3
Full chemistry, manufacturing and controls section, prepared in eCTD-ready format where the importing authority accepts it. Module 2 quality overall summary included.
CoA and MoA, per batch
HPLC assay, related substances, water content, residual solvents, sterility, endotoxin. Signed by the manufacturer's authorised QC head.
CoPP, WHO-GMP, MFG licence
Issued by the CDSCO (India) and apostilled where the destination requires it. Notarised copies included in the shipping pack.
Pack insert, labels, artwork
Destination-language PIL, labelling to local regulator standards (MHRA SmPC style for the UK, MoH style for GCC, SAHPRA for South Africa, BfArM for Germany). Artwork QC before print, not after.
Cold-chain data
Pre-shipment thermal validation on each shipper configuration, in-transit continuous temperature logging, on-arrival inspection with a signed record. Excursion protocol defined before dispatch, not after the shipment lands.
Pharmacovigilance
Local PV partner or a named PV contact organised in the destination market against registration. Periodic Safety Update Reports compiled to ICH E2C.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Strength (2mg or 3.5mg), total vial volume, destination market, whether it is tender, hospital pharmacy or wholesaler, and the target delivery window.
- We route to the right line. 29 bortezomib lines sit on our roster. Registered-market preference goes to facilities with in-country registration; cost-sensitive tender work goes to lines with the right price point.
- Commercial and regulatory offer. FOB / CIF price, lead time, a dossier status note per destination, and the documentation pack you can expect with the shipment. Inside one working day.
- Order, produce, release, ship. QC release on the Indian side. Cold-chain dispatch, real-time temperature monitoring, arrival inspection. Photo evidence of seal integrity on request.
- After delivery. Batch records, CoA and thermal logs archived for the full shelf life of the consignment. Pharmacovigilance contact opened on registration.
Bortezomib supply — the specific questions.
What strengths of bortezomib injection do you supply?
2mg and 3.5mg single-dose vials, lyophilised powder for reconstitution. Both intravenous and subcutaneous routes are supported on the labelling. Pack size is typically 1 vial per carton; multi-vial hospital packs are available against firm orders.
Which markets can you ship bortezomib into?
The UK (named-patient / MHRA specials where required), the GCC (UAE, KSA, Kuwait, Oman, Qatar, Bahrain — through licensed local importers), sub-Saharan Africa (Nigeria, Kenya, Ghana, South Africa — tender and hospital supply), and Germany (§72 AMG import channels). We do not supply into India.
What documentation is included with the consignment?
Batch-specific CoA and MoA, CoPP where required, WHO-GMP certificate, manufacturing licence, Certificate of Origin (chamber-attested), destination-language pack insert, and cold-chain temperature logs where applicable. A pharmacovigilance contact is nominated in the destination market on registration.
Do you provide CTD dossiers for registration?
Yes — full CTD Module 3 for MHRA, GCC central registration, national MoH, BfArM and equivalents. Module 2 summaries and Module 1 administrative sections are prepared in destination-specific format. See dossier preparation.
What are typical lead times?
For registered markets with stock on hand, 5-10 working days from confirmed order. Made-to-order batches, 6-10 weeks inclusive of QC release and destination artwork. Air-freight cold-chain transit to the UK or GCC: 3-5 days; sea-freight to Africa: 18-28 days.
Is there a minimum order quantity?
There is no hard MOQ for named-patient or specials orders — individual vials can be sourced and shipped under the right regulatory route. For hospital and tender supply, economics typically start to work at 200-500 vials per dispatch, depending on destination.
Can you ship to a freight forwarder we nominate?
Yes. Ex-works, FOB Mumbai (Nhava Sheva / Chhatrapati Shivaji airport), FCA, CIF and DAP are all supported. The cold-chain validation and temperature-logging responsibility ends at the Incoterm-specified hand-off point unless we have agreed differently in writing.
How do you handle excursions?
Temperature excursion protocol is set before dispatch and shared with you. If a logger records an excursion, the manufacturer's QA team issues an excursion assessment referencing the stability data package. Consignments are released, quarantined or rejected based on that assessment, not on a generic policy.
Send the specifics. You'll have a price inside one working day.
Strength, volume, destination, tender or hospital pharmacy, target delivery. That's the enquiry. Everything else is on us.