Paclitaxel injection — supplier from India to the UK, GCC and Africa.
A taxane cytotoxic for breast, ovarian and non-small-cell lung cancers. 30mg / 100mg / 260mg vials from Indian WHO-GMP facilities, with the CTD dossier, batch documentation and regulatory file a regulated-market buyer expects.
42 manufacturer lines · 30mg/5ml, 100mg/16.7ml, 260mg/43.3ml · full CTD dossier on file.
Active ingredient
Paclitaxel (Taxane cytotoxic). Mechanism: microtubule stabiliser (prevents depolymerisation of the mitotic spindle).
Strengths stocked
30mg/5ml, 100mg/16.7ml, 260mg/43.3ml. Concentrate for solution for infusion (6mg/ml). Approved intravenous administration per destination-country labelling.
Indications
Metastatic breast cancer (first- and second-line); Ovarian cancer (first- and second-line); Non-small-cell lung cancer. Common in paclitaxel-based regimens (AC-T, TAC, TC, weekly paclitaxel, paclitaxel + carboplatin); we supply the paclitaxel component only.
Storage
below 25°C, protected from light. Do not refrigerate (precipitation risk). Cold-chain validated transit to destination where the regulator requires it, with temperature logs issued on arrival.
Shelf life
24 months from manufacture; minimum 18 months at dispatch. Or we won't ship it.
Pack format
Single vial per carton, hospital pack. Amber-glass vial, chlorobutyl stopper, aluminium seal with flip-off cap. Outer carton and leaflet per destination regulator.
Hospital pharmacies, importers and tender desks across twelve markets.
India is our origin. We do not sell into the Indian market. Paclitaxel 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 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.
Temperature control
Pre-shipment thermal validation on each shipper configuration, continuous logging in transit, on-arrival inspection with a signed record. Excursion protocol defined before dispatch.
Pharmacovigilance
Local PV partner or a named PV contact organised in the destination market against registration. Periodic Safety Update Reports compiled to ICH E2C.
Complete the paclitaxel regimen.
Most paclitaxel protocols combine with other cytotoxics or supportive-care agents. We carry the full oncology cluster.
Bortezomib
Proteasome inhibitor, multiple myeloma. 2mg and 3.5mg lyophilised vials.
Docetaxel
Taxane cytotoxic, breast and NSCLC. 20mg / 80mg / 120mg concentrate.
Paclitaxel
Taxane cytotoxic, breast and ovarian. 30mg / 100mg / 260mg concentrate.
Gemcitabine
Nucleoside antimetabolite, NSCLC and pancreatic. 200mg / 1g / 2g vials.
Oxaliplatin
Platinum cytotoxic, colorectal (FOLFOX). 50mg / 100mg / 200mg vials.
All oncology →
120+ oncology SKUs: cytotoxics, targeted therapy, supportive care.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Strength, total vial volume, destination market, whether it is tender, hospital pharmacy or wholesaler, and the target delivery window.
- We route to the right line. 42 paclitaxel 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. Temperature-controlled dispatch, real-time 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.
Paclitaxel supply — the specific questions.
What strengths of paclitaxel do you supply?
30mg/5ml, 100mg/16.7ml, 260mg/43.3ml. Concentrate for solution for infusion (6mg/ml). Pack size is typically 1 vial per carton; multi-vial hospital packs are available against firm orders.
Which markets can you ship paclitaxel into?
The UK (named-patient / MHRA specials where required), the GCC 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 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 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. 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. Responsibility transfers at the Incoterm-specified hand-off point unless agreed differently in writing.
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.