Strensiq (asfotase alfa) is a refrigerated enzyme replacement therapy for hypophosphatasia, given by subcutaneous injection on a weight-based schedule.
M Care Exports supplies Strensiq (asfotase alfa), marketed by Alexion, to hospital pharmacies, metabolic bone and genetics centres, importers and tender desks in the GCC, Africa and the UK. If you are looking for Strensiq vials, send the destination, the vial strength, the quantity and your registration route, and we quote per destination.
Asfotase alfa exporter and bulk supplier from India.
"We need a partner for Strensiq" is the usual opening line from a hospital pharmacy or a distributor handling a rare-disease patient. Hypophosphatasia is a rare disease, and the quote turns on vial strength, pack, quantity, the destination's registration or import route, cold chain and Incoterms. M Care is a merchant-exporter: we confirm what is available for your destination before quoting, and we state the source of each line. Strensiq is a refrigerated biologic, so the cold chain is part of the offer from the first message, not an add-on.
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.
Enzyme replacement therapy (tissue-nonspecific alkaline phosphatase), sourced and documented for export.
Strensiq is a prescription tissue-nonspecific alkaline phosphatase enzyme replacement therapy, given by subcutaneous injection. The US label (Alexion Pharmaceuticals, Inc.) indicates it for perinatal/infantile- and juvenile-onset hypophosphatasia. The EU and UK texts describe long-term enzyme replacement therapy for the bone manifestations of paediatric-onset hypophosphatasia, and the UK SmPC adds "patients of all ages" with paediatric-onset disease. The US single-dose vials are 18 mg/0.45 mL, 28 mg/0.7 mL and 40 mg/mL (all at 40 mg/mL) and 80 mg/0.8 mL (100 mg/mL). The UK emc lists 40 mg/mL vials of 0.3, 0.45, 0.7 and 1.0 mL and a 100 mg/mL vial of 0.8 mL, in packs of 1 or 12. The EU marketing authorisation holder is Alexion Europe SAS, authorised 28 August 2015 under exceptional circumstances, with orphan designation EU/3/08/594 dated 3 December 2008. All three texts give the same standard regimen: 2 mg/kg three times weekly or 1 mg/kg six times weekly, which is 6 mg/kg per week.
Active ingredient
Asfotase alfa. Enzyme replacement therapy (tissue-nonspecific alkaline phosphatase).
Forms and strengths
12 mg/0.3 mL single-dose vial (UK 40 mg/mL presentation); 18 mg/0.45 mL single-dose vial; 28 mg/0.7 mL single-dose vial; 40 mg/mL single-dose vial; 80 mg/0.8 mL single-dose vial (100 mg/mL).
Indications
Asfotase alfa is a tissue-nonspecific alkaline phosphatase enzyme replacement therapy given by subcutaneous injection for hypophosphatasia, dosed by weight at 6 mg/kg per week and stored at 2 to 8 °C.
Administration
Subcutaneous. Solution for injection in single-dose vial.
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 are hospital pharmacists, metabolic and endocrine units, MoH and hospital tender desks, and licensed importers and distributors in the GCC, Africa and the UK. Typical enquiries read "I'm looking for Strensiq 40 mg/mL vials for a paediatric patient" or "We need a partner for asfotase alfa for a hospital import". Each destination has its own regulator, for example the Emirates Drug Establishment (EDE) in the UAE, NAFDAC in Nigeria and the MHRA in the UK, and for a rare-disease product the supply route depends on the destination regulator. We confirm it per enquiry before we quote.
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 asfotase alfa.
Dose by weight, then pick the vial. The US and UK texts give 6 mg/kg per week, as 2 mg/kg three times weekly or 1 mg/kg six times weekly, and the US label allows escalation to 9 mg/kg per week (3 mg/kg three times weekly) in perinatal/infantile-onset disease where efficacy is lacking. The UK SmPC sets a 1 mL maximum per injection and the US label splits volumes above 1 mL between two syringes and two sites. The US label says the 80 mg/0.8 mL vial must not be used in paediatric patients under 40 kg. Rotate sites, because localised lipoatrophy and lipohypertrophy can appear after several months. The US label carries a boxed warning for hypersensitivity including anaphylaxis, and the UK SmPC reports reactions consistent with anaphylaxis occurring within minutes of injection, including in patients treated for more than a year. Both texts recommend eye examinations and renal ultrasound at baseline and periodically. Asfotase alfa interferes with routine alkaline phosphatase assays, so tell the laboratory. Store at 2 to 8 °C in the original carton, protected from light, and do not freeze. The US label also says do not shake, to remove vials 15 to 30 minutes before injecting and to use within 3 hours of leaving the fridge.
The documentation pack a regulator actually asks for.
Strensiq is a cold-chain product. The US label requires 2 to 8 °C, protection from light, no freezing and no shaking, and says to administer within 3 hours of removal from refrigeration. The UK SmPC gives a 30-month shelf life at 2 to 8 °C and in-use stability of up to 3 hours at 23 to 27 °C. The UK marketing authorisation numbers shown on emc are PLGB 31187/0004 (100 mg/mL) and PLGB 31187/0005 (40 mg/mL), with the date of first authorisation or renewal shown as 1 January 2021. The EU product is authorised under exceptional circumstances and is under additional monitoring. M Care documentation covers batch certificates of analysis, temperature-controlled dispatch records and destination-aligned paperwork. We make no claim for M Care itself beyond merchant-exporter documentation, and we state the source of each line before quoting.
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 asfotase alfa.
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The full category listing for procurement desks.
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 asfotase alfa.
- 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.
Asfotase alfa supply, the specific questions.
What decides the cost of Strensiq per month for an importer?
We do not publish prices, and the monthly cost is not one figure. For a patient it follows the weight-based dose (6 mg/kg per week on the standard regimen), which fixes how many vials of which strength are used each week. For an importer the landed price depends on the vial strengths and pack (1 or 12 vials in the UK listing), the quantity, the registration or import route in the destination, cold-chain freight at 2 to 8 °C and Incoterms. M Care Exports quotes per destination once we know the patient weight range, strengths and volumes.
What is Strensiq used for, and what is its indication?
Strensiq is an enzyme replacement therapy for hypophosphatasia (HPP). The US label indicates it for perinatal/infantile- and juvenile-onset HPP. The EU and UK texts describe long-term enzyme replacement therapy for the bone manifestations of paediatric-onset HPP. Check the label that applies in your destination, because the wording differs by regulator.
Is Strensiq for adults, and is asfotase alfa for adults approved?
The labels frame the indication by age at onset, not by age at treatment. The US indication lists perinatal/infantile- and juvenile-onset HPP only. The UK SmPC says "patients of all ages" with paediatric-onset HPP, and states that adults with paediatric-onset disease need no dose adjustment. We do not suggest any use beyond the labelled indication.
Who is the Strensiq manufacturer?
The US label names Alexion Pharmaceuticals, Inc. of Boston, Massachusetts. The EU and UK marketing authorisation holder is Alexion Europe SAS, and emc lists Alexion Pharma UK Ltd as the UK company. M Care Exports is a merchant-exporter, not the manufacturer, and we confirm the source and presentation of each line before quoting.
Where do I find the Strensiq prescribing information?
The US prescribing information is on DailyMed, the EU product information is on the European Medicines Agency EPAR page, and the UK SmPC and leaflet are on emc. They differ on indication wording, vial presentations and dose escalation, so use the one for your destination. With an enquiry, we send the source references for the line we quote.
How is Strensiq supplied and stored as an enzyme replacement therapy?
Strensiq is a solution for subcutaneous injection in single-use vials. The US vials are 18 mg/0.45 mL, 28 mg/0.7 mL, 40 mg/mL and 80 mg/0.8 mL, and the UK lists 40 mg/mL and 100 mg/mL presentations. Store at 2 to 8 °C in the original carton, protected from light, and do not freeze. The US label says to administer within 3 hours of removal from refrigeration, so plan the cold chain to the pharmacy door. The EPAR, DailyMed and emc pages we read do not state any generic or biosimilar version, and we confirm the available source for your destination per enquiry.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-11-08.
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.
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.