Lamzede (velmanase alfa) is a Chiesi enzyme replacement therapy for the non-central nervous system manifestations of alpha-mannosidosis, supplied as a 10 mg vial, given as a weekly intravenous infusion at 1 mg/kg, and kept refrigerated.
M Care Exports supplies Lamzede (velmanase alfa), marketed by Chiesi, to hospital pharmacies, metabolic and genetics units, importers and tender desks in the GCC, Africa and the UK. If you are looking for the 10 mg vial for a named patient or a rare-disease programme, send the destination, the number of patients with their weights, and the quantity, and we quote per destination.
Velmanase alfa exporter and bulk supplier from India.
"We need a partner for Lamzede" is a typical enquiry from a hospital metabolic unit or a tender desk. M Care is a merchant-exporter: we quote against your specification and confirm which route your destination uses. Lamzede is a single presentation, a 10 mg lyophilised powder in a single-dose vial, and the order size follows the patient's weight, not a fixed pack. The dose is 1 mg/kg every week, so a 40 kg patient needs four vials for each infusion. Both the US label and the UK SmPC tell the pharmacy to round the vial count up to the next whole number, and only the volume matching the dose is given. Cartons of 1, 5 or 10 vials appear on both documents (the SmPC notes that not all sizes may be marketed). Because every vial is refrigerated at 2 to 8 °C, the quote also turns on cold-chain packing, the registration or import route in the destination, and Incoterms.
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 (recombinant human lysosomal alpha-mannosidase), sourced and documented for export.
Lamzede is recombinant human lysosomal alpha-mannosidase, an enzyme replacement therapy (ERT) from Chiesi, for alpha-mannosidosis, a lysosomal storage disease. The US label (manufactured for Chiesi USA, Inc.; Chiesi Farmaceutici S.p.A. holds the trademark; marked revised 2/2023, initial US approval 2023) names the active substance velmanase alfa-tycv and indicates it for non-central nervous system manifestations of alpha-mannosidosis in adult and paediatric patients. The EMA page covers non-neurological manifestations in patients with mild to moderate alpha-mannosidosis, lists Chiesi Farmaceutici S.p.A. as marketing authorisation holder, authorisation on 23 March 2018, orphan designation (EU/3/04/260), authorisation under exceptional circumstances because of the rarity of the disease, and additional monitoring. The UK emc SmPC lists Chiesi Limited as holder, with first authorisation on 1 January 2021 and renewal on 13 January 2023. All three give 1 mg/kg once weekly by IV infusion, and the US label and UK SmPC describe a 10 mg vial that gives 2 mg/mL after reconstitution.
Active ingredient
Velmanase alfa (velmanase alfa-tycv in the US). Enzyme replacement therapy (recombinant human lysosomal alpha-mannosidase).
Forms and strengths
10 mg single-dose vial (powder for solution for infusion, 2 mg/mL after reconstitution).
Indications
Recombinant human lysosomal alpha-mannosidase given as a weekly intravenous infusion for non-central nervous system (non-neurological) manifestations of alpha-mannosidosis.
Administration
Intravenous. Powder for solution for infusion (lyophilised powder in a 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 in metabolic, genetics and paediatric 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 Lamzede 10 mg vials for a patient with alpha-mannosidosis" or "We need a partner for velmanase alfa for a ministry rare-disease programme". Alpha-mannosidosis is rare, so the route to the patient depends on the destination regulator: a registered product, or an unlicensed or named-patient import where the regulator allows one. We do not assume which applies. For example, the Emirates Drug Establishment (EDE) registers medicines in the UAE, NAFDAC regulates drug imports in Nigeria and the MHRA is the UK regulator, and M Care Exports confirms the route per enquiry before quoting.
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 velmanase alfa.
Start with the weight, because the vial count moves with it. The dose is 1 mg/kg actual body weight every week, and the pharmacy rounds the vial count up to the next whole number. On the US label, vials come out of the refrigerator for about 30 minutes, each is reconstituted with 5 mL of Sterile Water for Injection run down the inside wall to limit foaming, left to stand 5 to 15 minutes (the UK SmPC says about 5 to 10), then tilted and rolled gently for 15 to 20 seconds. Do not invert, swirl or shake. Each vial gives 2 mg/mL. The US label asks for an infusion pump with a low protein binding 0.2-micron in-line filter, a minimum of 60 minutes for patients up to 49 kg, and a maximum rate of 25 mL/hour from 50 kg. The UK SmPC also caps the rate at 25 mL/hour and sets a minimum duration of 50 minutes. Both carry a hypersensitivity warning, with the US label boxed. The US label says appropriate medical support, including cardiopulmonary resuscitation equipment, should be readily available, the SmPC says appropriate medical support should be readily available, and the SmPC advises observing patients for infusion-related reactions for at least an hour afterwards. The US label says to consider pretreatment with antihistamines, antipyretics or corticosteroids, while the SmPC notes most trial patients were not routinely premedicated. After reconstitution, the US label allows up to 24 hours refrigerated, with infusion completed within 10 hours of leaving the refrigerator.
The documentation pack a regulator actually asks for.
Lamzede is a cold-chain biologic. The US label requires unopened vials refrigerated at 2 to 8 °C in the original carton, protected from light, and never frozen. The UK SmPC says to store and transport refrigerated at 2 to 8 °C, not to freeze, and to keep vials in the original package protected from light, with a shelf life of 3 years. Export consignments therefore travel in qualified insulated shippers with temperature loggers, timed to the receiving site. The UK SmPC states that the reconstituted solution is chemically and physically stable for 24 hours at 2 to 8 °C, but should be used immediately from a microbiological standpoint. The EMA page and the UK SmPC show Lamzede under additional monitoring. M Care documentation covers batch certificates of analysis, export documents and destination-aligned dossier support where the regulator asks for it. We state the source and status of each line before quoting, and make no claim of our own to manufacturer certifications.
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 velmanase alfa.
Asfotase alfa
Enzyme replacement therapy · paediatric-onset hypophosphatasia · 2-8°C
Nitisinone
HPPD inhibitor · hereditary tyrosinaemia type 1, alkaptonuria (EU) · 2-8°C
Odevixibat
IBAT inhibitor · pruritus in PFIC and Alagille syndrome
Metreleptin (Myalepta)
Leptin analogue · lipodystrophy with leptin deficiency · 2-8°C
All diabetes & endocrine
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 velmanase 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.
Velmanase alfa supply, the specific questions.
What is the Lamzede indication?
Lamzede is enzyme replacement therapy for alpha-mannosidosis, and the wording differs by market. The US label indicates it for non-central nervous system manifestations of alpha-mannosidosis in adult and paediatric patients. The EMA page and the UK SmPC cover non-neurological manifestations in patients with mild to moderate alpha-mannosidosis. The EMA notes that the medicine does not appear to reach the brain and does not improve effects such as loss of hearing or loss of control over movement. Always check the label for the destination market.
Who makes Lamzede, and what does Chiesi hold in each market?
Lamzede is a Chiesi product. The US label names Chiesi Farmaceutici S.p.A. of Parma, Italy, as manufacturer and trademark owner, with the product manufactured for Chiesi USA, Inc. The EMA page lists Chiesi Farmaceutici S.p.A. as marketing authorisation holder, and the UK emc SmPC lists Chiesi Limited, Manchester. M Care Exports is a merchant-exporter, not the manufacturer, and we confirm the source of each supply line before quoting.
Is there a Lamzede EMA authorisation, and what are the exceptional circumstances?
Yes. The EMA page shows marketing authorisation issued on 23 March 2018, after an opinion adopted on 14 December 2017. The product is an orphan medicine (designated 26 January 2005, EU/3/04/260) and was authorised under exceptional circumstances, because complete information could not be obtained given the rarity of alpha-mannosidosis. The medicine is under additional monitoring. The EU indication covers mild to moderate disease, so check the full SmPC for the destination.
Where can I find the Lamzede PI and the velmanase alfa FDA label and approval?
The US prescribing information (PI) names the active substance velmanase alfa-tycv and shows initial US approval in 2023. The copy on the FDA's Drugs@FDA site is marked revised 2/2023, with a note that it may not be the latest, and the DailyMed listing for Chiesi USA, Inc. shows the same 2/2023 revision; check either site for the current version. The FDA label carries a boxed warning for severe hypersensitivity reactions including anaphylaxis, and lists no contraindications. The EU product information is on the EMA page, and the UK SmPC is on emc.
What sets the Lamzede cost or velmanase alfa price for an importer?
We do not publish a figure, because Lamzede has no single landed price. It depends on the number of 10 mg vials, which follows each patient's weight at 1 mg/kg every week, the carton size, the quantity and delivery schedule, cold-chain packing, the destination's registration or import route, and the Incoterms. For a rare disease like alpha-mannosidosis, the order is often for a small number of named patients. M Care Exports quotes per destination once we have the weights, the schedule and the delivery point.
Is there a generic or biosimilar of Lamzede, and what about NICE and other HTA bodies?
The US label, the EMA page and the UK SmPC we read list only the Chiesi product, and none mentions a generic or biosimilar velmanase alfa. We therefore quote Lamzede as the originator brand. We have not reviewed NICE or other health technology appraisals for this page; funding decisions are separate from the regulatory label. Tell us the destination, and M Care Exports confirms the registered or named-patient route 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.
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