Enoxaparin sodium biosimilar — Indian WHO-GMP supply for VTE prophylaxis, DVT/PE treatment, ACS and pregnancy anticoagulation.
The single most-prescribed parenteral anticoagulant in hospital medicine. Low-molecular-weight heparin biosimilar with predictable anti-Xa activity, weight-based subcutaneous dosing, no routine aPTT monitoring. Pre-filled syringes 20mg, 40mg, 60mg, 80mg, 100mg, 120mg and 150mg plus 30,000 IU multi-dose vial from Indian WHO-GMP biosimilar facilities. WHO Essential Medicines List item. Cold-chain 2-8°C validated lane mandatory.
Multiple WHO-GMP biosimilar partner lines · 20mg / 40mg / 60mg / 80mg / 100mg / 120mg / 150mg pre-filled syringes plus 30,000 IU multi-dose vial · CTD biosimilar dossier on file · Cold-chain 2-8°C validated lane.
Active ingredient
Enoxaparin sodium, a low-molecular-weight heparin biosimilar produced by alkaline depolymerisation of unfractionated heparin from porcine intestinal mucosa. Average molecular weight 4,500 Daltons (range 3,800-5,000 Da). Mechanism: binds antithrombin III, accelerating inactivation of factor Xa (predominant) and factor IIa (thrombin, lesser extent). Anti-Xa to anti-IIa activity ratio approximately 3.6:1 — more selective Xa inhibition than unfractionated heparin (1:1 ratio), giving predictable anticoagulant response per unit dose.
Strengths stocked
Pre-filled syringes are the dominant format: 40mg/0.4mL is the highest-volume tender line for VTE prophylaxis in medical and surgical inpatients. 20mg/0.2mL for low-dose prophylaxis (renal impairment, low body weight, paediatric). 60mg, 80mg, 100mg, 120mg, 150mg for weight-based VTE treatment and ACS dosing. 30,000 IU/3mL multi-dose vial for hospital pharmacy bulk dispensing and haemodialysis circuit anticoagulation. PFS pack includes integrated needle-shield safety device per EU MDR and OSHA sharps directives.
Indications
VTE prophylaxis (medical inpatients, post-surgical orthopaedic / abdominal / gynaecological), VTE treatment (DVT, PE), unstable angina and NSTEMI with aspirin, STEMI in selected protocols, AF cardioversion bridging, pregnancy VTE prophylaxis and treatment (NICE NG133 first-line over warfarin), mechanical heart valve bridging, cancer-associated thrombosis. Standard prophylactic dose 40mg SC once daily; treatment 1 mg/kg SC twice daily or 1.5 mg/kg SC once daily; CrCl <30 mL/min dose halved with anti-Xa monitoring.
Storage
Cold-chain 2-8°C MANDATORY. Do not freeze — freezing causes potency loss and the syringe is rejected. Protect from light. Pre-filled syringe excursion to 25°C tolerated for up to 30 days per manufacturer SmPC; beyond that, batch is rejected. Multi-dose vial in-use stability 28 days at 2-8°C after first puncture. Do NOT expel the air bubble in the pre-filled syringe — it ensures full dose delivery and prevents bruising at injection site. Validated cold-chain shipper with continuous temperature logger on every consignment, pre-shipment qualification per WHO TRS 961 Annex 9.
Shelf life
24 months from manufacture for pre-filled syringe; 30 months for multi-dose vial. Minimum 18 months at dispatch. Or we won't ship it.
Pack format
Pre-filled syringe: Type-I borosilicate glass barrel, FluroTec-coated bromobutyl plunger stopper, stainless-steel staked needle (27G or 29G), integrated passive needle-shield safety device. 2 PFS or 10 PFS per carton, hospital pack. Multi-dose vial: Type-I clear glass, halobutyl rubber stopper, aluminium seal with flip-off cap. Outer carton and PIL in destination-regulator language. HIT type II warning (heparin-induced thrombocytopenia) and spinal/epidural haematoma neuraxial blockade warning prominently set on SmPC.
Hospital pharmacies, surgical units, antenatal services and tender desks across thirty markets.
India is our origin. We do not sell into the Indian market. Enoxaparin biosimilar is exported only.
United Kingdom
Enoxaparin is core NHS hospital pharmacy stock — VTE prophylaxis is a CQUIN (Commissioning for Quality and Innovation) audited indicator at every adult acute trust. Antenatal and obstetric units use it as first-line per NICE NG133 and RCOG Green-top Guideline 37a (pregnancy VTE). Where the primary licensed biosimilar cannot fill — Inhixa, Arovi, Becat, Crusia, Hibor — the MHRA Specials / named-patient import route is available, see MHRA Specials. Cold-chain 2-8°C validated lane to NHS regional procurement hubs.
GCC (UAE, KSA, Kuwait, Oman, Qatar, Bahrain)
Through local licensed importers, against MoH formulary tender awards (NUPCO and Saudi MoH — King Faisal Specialist Hospital and SEHA major buyers; MoHAP, DHA and DOH Abu Dhabi for UAE; Kuwait MoH Central Drug Store; MoPH Qatar including Hamad Medical Corporation; MoH Oman; NHRA Bahrain). Surgical-prophylaxis and ACS tender lots are particularly high-volume. SFDA, MoHAP and GCC central registration supported with full CTD biosimilar dossier, including comparability exercise versus reference Lovenox / Clexane.
Nigeria, Kenya, Ghana, South Africa, Ethiopia, Tanzania, Uganda, Rwanda
Public-sector hospital tenders (NAFDAC for Nigeria, KEMSA + MEDS for Kenya, FDA Ghana + Central Medical Stores, SAHPRA for South Africa, EFDA + EPSS for Ethiopia, TMDA + MSD for Tanzania, NDA + NMS for Uganda) and teaching-hospital supply. Enoxaparin is the highest-volume LMWH tender line in African public-sector procurement — surgical-prophylaxis programmes, maternal-health VTE prophylaxis, and ACS coronary-care expansion. Cold-chain validated lane to country central medical stores; in-country onward distribution is the importer's responsibility on temperature-mapped vehicles.
Germany, France, Brazil, Mexico, Philippines
Supply via licensed importers under §72 AMG (Germany), ANSM equivalent (France), ANVISA (Brazil), COFEPRIS (Mexico), FDA Philippines, with Qualified Person (QP) certification on EU arrival. Biosimilar CTD dossier, comparability exercise, and CoPP prepared for BfArM, ANSM, ANVISA, COFEPRIS and FDA Philippines recognition. M Care does not hold US FDA or Australian TGA registrations for enoxaparin biosimilar.
Renal dose adjustment, HIT type II, neuraxial haematoma — enoxaparin's safety margins are tight, and the wrong dose kills.
Standard prophylactic dose 40mg SC once daily; medical inpatient or post-surgical. Treatment dose 1 mg/kg SC twice daily or 1.5 mg/kg SC once daily; ACS 1 mg/kg SC twice daily. Renal impairment is the killer issue: enoxaparin is renally cleared and accumulates in CrCl <30 mL/min. Treatment dose is halved to 1 mg/kg SC once daily in CrCl <30 mL/min, and anti-Xa monitoring is mandatory — peak level 4 hours post-dose, target 0.5-1.0 IU/mL for treatment and 0.2-0.5 IU/mL for prophylaxis. Anti-Xa is the only meaningful lab measure; aPTT is unreliable for LMWH. HIT type II (heparin-induced thrombocytopenia) — onset 5-14 days, autoimmune IgG against PF4-heparin complexes, platelets fall <100,000 or by 50% from baseline; discontinue enoxaparin immediately and switch to a non-heparin anticoagulant (argatroban, bivalirudin, fondaparinux). The 4Ts score and HIT antibody assay confirm. Neuraxial blockade — FDA black-box warning: spinal or epidural haematoma with permanent paralysis has occurred with concurrent LMWH and spinal/epidural anaesthesia or lumbar puncture. Delay neuraxial procedure 12 hours after prophylactic dose, 24 hours after treatment dose; resume LMWH ≥4 hours after catheter removal. Pregnancy: UK NICE NG133 first-line over warfarin (warfarin is teratogenic and crosses placenta; enoxaparin does not). Reversal: protamine sulfate is partial only (~60-65% anti-Xa neutralisation) — 1 mg protamine per 1 mg enoxaparin given within 8 hours, half-dose if 8-12 hours, no benefit beyond 12 hours; fresh frozen plasma if active bleeding. Subcutaneous administration: abdominal area, anterolateral or posterolateral wall, 2 inches from umbilicus, rotate sites left-right with each dose to avoid bruising and lipohypertrophy. Do NOT expel the air bubble in the pre-filled syringe — it ensures complete dose delivery and prevents bruising. Storage: 2-8°C cold chain; do not freeze — freezing causes potency loss and the syringe is rejected.
The biosimilar documentation pack a regulator actually asks for.
Enoxaparin sodium is a WHO EML listed biological. Biosimilar registration requires a comparability exercise versus the reference product (Lovenox / Clexane / Sanofi Aventis innovator) demonstrating physicochemical equivalence, biological-activity equivalence and clinical equivalence. Our role is manufacturer-facing — we sit between the Indian WHO-GMP biosimilar facility and your clinical, regulatory or procurement team and take the paperwork off both sides.
CTD biosimilar dossier, Module 3
Full chemistry, manufacturing and controls section for biosimilar, prepared in eCTD-ready format where the importing authority accepts it. Module 2 quality overall summary and biosimilarity summary included. Comparability exercise versus reference Lovenox / Clexane: physicochemical (NMR, mass spectrometry, HPLC chain-length distribution), biological activity (anti-Xa, anti-IIa, antithrombin binding affinity), and clinical PK/PD bioequivalence data per EMA, MHRA, ICH Q5E and WHO biosimilar guideline.
CoA and MoA, per batch
Anti-Xa potency (90-110% of label per Ph.Eur. monograph), anti-IIa potency, anti-Xa/anti-IIa ratio (target 3.3-5.3), molecular weight distribution by HPLC (Mw 3,800-5,000 Da; ≥68% chains in 2,000-8,000 Da range), nitrogen content, sodium content, pH, sterility, bacterial endotoxin (≤0.01 EU/IU anti-Xa), particulate matter, dermatan sulfate impurity, oversulfated chondroitin sulfate (post-2008 contamination crisis screening) — signed by the manufacturer's authorised QC head.
CoPP, WHO-GMP, MFG licence
Issued by CDSCO (Central Drugs Standard Control Organization, India) and apostilled where the destination requires it. Notarised copies in the shipping pack. Biosimilar comparability dossier prepared separately for EMA, MHRA, GCC central registration and African public-sector procurement. M Care does not hold US FDA or Australian TGA registrations. WHO PQ biotherapeutic pathway evaluation supported where partner manufacturer is in WHO PQ assessment.
Pack insert, labels, artwork
Destination-language PIL, labelling to local regulator standards. HIT type II warning (heparin-induced thrombocytopenia, onset 5-14 days, monitor platelets), FDA black-box neuraxial blockade warning (spinal/epidural haematoma risk with concurrent neuraxial anaesthesia), renal-impairment dose-adjustment instruction (CrCl <30 mL/min — dose halved + anti-Xa monitoring), pregnancy use per NICE NG133, and do-not-freeze cold-chain warning prominently set per current EMA, MHRA and FDA labelling requirement. Patient-facing PIL covers subcutaneous injection technique, abdominal site rotation, do-not-expel-air-bubble instruction, and bruising guidance. Artwork QC before print, not after.
Cold-chain validation
Pre-shipment validation on each shipper configuration per WHO TRS 961 Annex 9 and IATA CEIV Pharma. Validated 2-8°C cold-chain shipper with phase-change-material panels, payload qualified for ≥120 hours summer profile (ISTA 7E) and ≥168 hours winter profile. Continuous temperature logger (Berlinger or equivalent USB or NFC logger) in every shipper, calibrated to NIST-traceable reference, log file released with consignment paperwork. Freeze excursion is a batch-rejection trigger; deviation procedure on every shipper. See cold-chain validation.
Pharmacovigilance
Local PV partner or a named PV contact organised in the destination market against registration. Periodic Safety Update Reports compiled to ICH E2C. HIT type II events, neuraxial haematoma cases, anaphylaxis, hyperkalaemia (aldosterone suppression in long-term use), and cold-chain breach-related potency complaints remain the PSUR priority signals. Biosimilar pharmacovigilance plan separate from chemical generic — substitution events and immunogenicity monitoring documented per EMA biosimilar guideline.
Cold-chain biologicals, anticoagulation and supportive-care cluster.
Enoxaparin sits inside our haematology-biologicals cluster — cold-chain validated lane, biosimilar regulatory pathway, hospital-pharmacy parenteral focus.
Albumin
Human serum albumin, plasma-derived biological. 20% solution, hypovolaemia and hypoalbuminaemia. Cold-chain.
All haematology & biologicals →
Anticoagulants, plasma derivatives, biosimilars, growth factors. Cold-chain validated lane across the cluster.
All products →
1,000+ SKUs across anti-infectives, oncology, cardiovascular, haematology, anaesthesia, critical care.
Cold-chain validation
Validated 2-8°C shippers, NIST-traceable loggers, WHO TRS 961 Annex 9 and IATA CEIV Pharma compliance.
Named-patient import, UK
MHRA Specials route for UK NHS hospital pharmacy supply during shortage of licensed enoxaparin biosimilar.
MoH registration, GCC
SFDA, MoHAP and GCC central registration support with full biosimilar CTD dossier and comparability exercise.
Strength · pre-filled syringe count · destination · cold-chain lane. One working day to a quote.
- Send us the specifics. Strength (20mg / 40mg / 60mg / 80mg / 100mg / 120mg / 150mg PFS, or 30,000 IU multi-dose vial), syringe or vial count, destination, NHS hospital pharmacy / GCC ICU tender / African public-sector / antenatal-services VTE programme / cancer-associated-thrombosis programme. Flag if biosimilar comparability dossier, HIT-monitoring SmPC documentation, neuraxial-blockade warning labelling, or NICE NG133 pregnancy-use documentation is needed for the receiving formulary.
- We route to the right line. Multiple WHO-GMP enoxaparin biosimilar lines on the M Care roster, including manufacturers in WHO PQ biotherapeutic pathway evaluation. Comparability data versus reference Lovenox / Clexane available against NDA.
- Commercial and regulatory offer. FOB / CIF price, lead time, biosimilar dossier status per destination, cold-chain shipper specification with freeze-protection profile, and the documentation pack you'll receive. Inside one working day.
- Order, produce, release, ship. QC release on the Indian side — anti-Xa potency, molecular-weight distribution, oversulfated-chondroitin-sulfate screen. Validated 2-8°C cold-chain shipper, continuous temperature logger, in-transit monitoring, on-arrival inspection. Photo evidence of seal integrity and logger check on request.
- After delivery. Batch records, CoA, biosimilar comparability summary, and thermal logs archived for the full shelf life. Pharmacovigilance contact opened on registration; HIT type II events, neuraxial haematoma cases, anaphylaxis, hyperkalaemia and cold-chain potency complaints remain the PSUR priority signals. Biosimilar substitution and immunogenicity monitoring documented per EMA guideline.
Enoxaparin biosimilar supply — the specific questions.
What strengths and pack formats of enoxaparin sodium do you supply?
Pre-filled syringes 20mg/0.2mL (2,000 IU anti-Xa), 40mg/0.4mL (4,000 IU), 60mg/0.6mL (6,000 IU), 80mg/0.8mL (8,000 IU), 100mg/1mL (10,000 IU), 120mg/0.8mL (12,000 IU) and 150mg/1mL (15,000 IU); plus 30,000 IU/3mL multi-dose vial. 40mg PFS is the highest-volume tender line for VTE prophylaxis. Pre-filled syringes ship with integrated passive needle-shield safety device per EU MDR and OSHA sharps directives. Do not expel the air bubble in the PFS — it ensures complete dose delivery and prevents bruising at injection site. Cold-chain 2-8°C mandatory; do not freeze.
Is your enoxaparin a biosimilar, and do you have comparability data versus Lovenox / Clexane?
Yes. Our partner facilities produce enoxaparin sodium biosimilar under the WHO biosimilar pathway and EMA biosimilar guideline. Comparability exercise versus reference Lovenox / Clexane (Sanofi Aventis innovator) covers physicochemical equivalence (NMR fingerprint, mass spectrometry, HPLC chain-length distribution, anti-Xa/anti-IIa ratio target 3.3-5.3), biological-activity equivalence (anti-Xa potency 90-110% of label per Ph.Eur., antithrombin binding affinity), and clinical PK/PD bioequivalence per ICH Q5E. Full comparability dossier available against NDA. WHO PQ biotherapeutic pathway evaluation supported where partner manufacturer is in WHO PQ assessment. M Care does not hold US FDA or Australian TGA registrations for enoxaparin biosimilar.
How is the cold-chain lane validated, and what happens if a freeze excursion occurs in transit?
Pre-shipment validation on each shipper configuration per WHO TRS 961 Annex 9 and IATA CEIV Pharma. Validated 2-8°C cold-chain shipper with phase-change-material panels, payload qualified for ≥120 hours summer profile (ISTA 7E) and ≥168 hours winter profile. Continuous temperature logger (Berlinger or equivalent USB/NFC logger) in every shipper, calibrated to NIST-traceable reference, log file released with consignment paperwork. Freeze excursion is a batch-rejection trigger — frozen enoxaparin loses potency and is not re-released, even if the syringe thaws to apparent normalcy. Deviation procedure on every shipper, replacement consignment dispatched against root-cause investigation. Pre-filled syringe excursion to 25°C is tolerated for up to 30 days per manufacturer SmPC; beyond that, batch is rejected. See cold-chain validation.
How is the renal-impairment dose adjustment and anti-Xa monitoring documented?
The destination-language PIL and SmPC carry the renal dose-adjustment instruction prominently. Enoxaparin is renally cleared and accumulates in CrCl <30 mL/min: treatment dose halved to 1 mg/kg SC once daily, and anti-Xa monitoring is mandatory — peak level 4 hours post-dose, target 0.5-1.0 IU/mL for treatment and 0.2-0.5 IU/mL for prophylaxis. aPTT is unreliable for LMWH and is not used. The dispensing-side responsibility (calculating CrCl, ordering anti-Xa labs, dose adjustment) sits with the prescribing pharmacy and clinician; the manufacturer-side responsibility (clear labelling and SmPC dose tables) is ours. Anti-Xa potency CoA per batch is part of the standard documentation pack.
Which markets can you ship enoxaparin biosimilar into?
The UK (NHS hospital pharmacy supply or named-patient / MHRA Specials route during shortage), the GCC (UAE, Saudi Arabia, Kuwait, Oman, Qatar, Bahrain) through licensed local importers — surgical-prophylaxis and ACS tenders are the main channels — sub-Saharan Africa (Nigeria, Kenya, Ghana, South Africa, Ethiopia, Tanzania, Uganda, Rwanda) for tender and teaching-hospital supply, including maternal-health VTE prophylaxis programmes. Egypt, Jordan, Iraq on the Levant side. Germany under §72 AMG, France under ANSM-equivalent route, Brazil (ANVISA), Mexico (COFEPRIS) and the Philippines (FDA Philippines). M Care does not supply into the United States or Australia — no FDA or TGA registration held for enoxaparin biosimilar. We do not supply into India. Full market coverage is at markets.
What documentation is included with an enoxaparin consignment?
Every consignment ships with a batch-specific Certificate of Analysis (anti-Xa potency 90-110% per Ph.Eur., anti-IIa potency, anti-Xa/anti-IIa ratio 3.3-5.3, molecular-weight distribution by HPLC, sterility, bacterial endotoxin ≤0.01 EU/IU anti-Xa, oversulfated-chondroitin-sulfate screen post-2008 contamination crisis, particulate matter), Method of Analysis, Certificate of Pharmaceutical Product (CoPP), WHO-GMP certificate, manufacturing licence, biosimilar comparability summary versus reference Lovenox / Clexane, Certificate of Origin (chamber-attested), destination-language pack insert with HIT type II warning + FDA black-box neuraxial-blockade warning + renal dose-adjustment instruction + pregnancy NICE NG133 use note + do-not-freeze cold-chain warning, plus continuous temperature logs from pre-dispatch through on-arrival. PV contact nominated on registration; biosimilar substitution and immunogenicity monitoring documented per EMA guideline.
What are typical lead times for enoxaparin orders, and what is the cold-chain transit profile?
For registered markets with stock on hand, dispatch is typically 5-10 working days from confirmed order. For tender awards (NUPCO, KEMSA, NAFDAC, SAHPRA, EFDA, public-sector maternal-health VTE programmes), the lead time is set in the tender award document. For UK NHS hospital pharmacy ad-hoc supply with urgency flagged, air-freight out of Mumbai in a validated 2-8°C cold-chain shipper can be on a flight within 72 hours. Made-to-order biosimilar batches run 8-12 weeks inclusive of QC release, comparability re-confirmation and destination artwork. Enoxaparin biosimilar requires cold-chain 2-8°C in transit — non-negotiable. Validated shipper, phase-change-material panels, continuous temperature logger, payload qualified for ≥120 hours summer profile and ≥168 hours winter profile per ISTA 7E. Freeze excursion is a batch-rejection trigger. Transit temperature log file is released with consignment paperwork on every shipment for QA traceability.
Send the specifics. You'll have a price inside one working day.
Strength (20mg / 40mg / 60mg / 80mg / 100mg / 120mg / 150mg PFS, or 30,000 IU multi-dose vial), syringe or vial count, destination, NHS hospital pharmacy / GCC ICU tender / African public-sector / antenatal-services VTE programme / cancer-associated-thrombosis programme, target delivery, biosimilar comparability documentation if required. That's the enquiry. Everything else is on us.