Deflazacort substitutes for prednisolone at roughly 6mg to 5mg, but the bone-sparing and glucose-sparing advantage often claimed for that switch holds up only inconsistently across the trial record.
Deflazacort ships as an oral tablet corticosteroid across UK, EU, Gulf, African, Latin American, Southeast Asian and CIS formularies, most often reviewed by tender desks and hospital procurement as a substitute for, or an addition alongside, prednisolone. M Care supplies 26 deflazacort tablet lines across 6mg, 12mg, 24mg and 30mg strengths, sourced from WHO-GMP certified Indian manufacturers, for licensed importers outside India and the United States.
Deflazacort exporter and bulk supplier from India.
M Care exports deflazacort exclusively as oral tablets, in strengths of 6mg, 12mg, 24mg and 30mg, packed in standard blister strips within cartons suitable for ambient air and sea freight. The molecule needs no cold chain and is not subject to narcotic or psychotropic export controls. Every consignment ships with a batch-specific certificate of analysis, the source manufacturer's WHO-GMP certificate, and a certificate of pharmaceutical product or free sale certificate for destination-country registration, since deflazacort is a prescription-only medicine in every market M Care serves. M Care's own export documentation runs on its CDSCO licence and ISO 9001:2015 certified quality system.
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.
Corticosteroid (glucocorticoid, oxazoline derivative of prednisolone), sourced and documented for export.
Tender committees switching between deflazacort and prednisolone anchor the decision on a single number: roughly 6mg of deflazacort to 5mg of prednisolone, a ratio stated in the UK Calcort Summary of Product Characteristics and drawn from anti-inflammatory potency studies with a documented range of 0.69 to 0.89. What is less settled is the comparative safety case built on top of that ratio. Bone density trials favour deflazacort in some settings, a randomized kidney transplant trial recorded 3.0% lumbar bone loss on deflazacort against 9.1% on prednisone over 78 weeks, and a juvenile chronic arthritis trial found a significant spinal bone-mineral advantage, but a polymyalgia rheumatica trial found the opposite at three months, with deflazacort causing greater bone loss than prednisolone, a gap that closed only by six to twelve months. Glucose data follow a similar pattern: several comparisons at the standard 1.2:1 conversion found deflazacort less diabetogenic than prednisone, but a study run at a higher 1.5mg:1mg ratio found that difference narrow, which its authors read as evidence the lower ratio had understated prednisone's equivalent dose rather than as proof deflazacort is metabolically safer. Deflazacort itself is an oxazoline derivative of prednisolone, an inactive prodrug hydrolysed by plasma esterases to its active metabolite, 21-desacetyldeflazacort, and it carries the same corticosteroid class warnings as prednisolone regardless of which comparative study a buyer is shown.
Active ingredient
Deflazacort. Corticosteroid (glucocorticoid, oxazoline derivative of prednisolone).
Forms and strengths
6 mg; 12 mg; 24 mg; 30 mg.
Indications
Deflazacort is an oral corticosteroid prodrug, an oxazoline derivative of prednisolone hydrolysed by plasma esterases to its active metabolite 21-desacetyldeflazacort, used across rheumatology, respiratory, renal and neuromuscular indications. It is commonly evaluated against prednisolone at a documented potency ratio of roughly 6mg deflazacort to 5mg prednisolone. M Care supplies deflazacort exclusively as oral tablets in 6mg, 12mg, 24mg and 30mg strengths, sourced from WHO-GMP certified Indian manufacturers for licensed importers outside India and the United States.
Administration
Oral. Tablet.
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 for deflazacort tablets are hospital and rheumatology procurement teams, nephrology and respiratory tender desks, and licensed pharmaceutical importers across the UK, EU, Gulf, Africa, Latin America, Southeast Asia and CIS, typically evaluating deflazacort against prednisolone for a specific formulary slot rather than sourcing it as a first-line steroid. Regulatory affairs teams preparing generic submissions for markets where Calcort or an equivalent brand is already registered are a recurring buyer type. India is the country of manufacture only; M Care does not serve Indian or US buyers for this molecule.
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 deflazacort.
A pharmacist reviewing a deflazacort-for-prednisolone switch should check three things this evidence review surfaces. First, the conversion ratio: the UK Calcort SmPC states roughly 6mg deflazacort to 5mg prednisolone, drawn from a documented potency range of 0.69 to 0.89, so a straight 1:1 substitution under-doses. Second, the bone and glucose evidence behind that ratio is trial-specific, not universal: deflazacort's bone-sparing effect was clear in a kidney transplant trial and a juvenile arthritis trial but absent by six to twelve months in a polymyalgia rheumatica trial, and its glucose-sparing effect narrowed in a study that used a higher, arguably more accurate, 1.5mg to 1mg conversion against prednisone. Third, activation differs: deflazacort is an inactive prodrug hydrolysed by plasma esterases to 21-desacetyldeflazacort, not by hepatic first-pass metabolism, which changes how hepatic impairment affects it compared with prednisone. The class-wide corticosteroid checks still apply in full regardless of which drug is chosen: hypothalamic-pituitary-adrenal axis suppression on withdrawal, growth velocity in pediatric long-term use, and live vaccine timing before starting therapy. Every line M Care stocks is an oral tablet monotherapy across 6mg, 12mg, 24mg and 30mg; the catalogue carries no oral suspension, capsule or injectable deflazacort.
The documentation pack a regulator actually asks for.
Deflazacort tablets ship with a documentation pack built for prescription-only medicine registration: batch-specific certificate of analysis, the source manufacturer's WHO-GMP certificate, a certificate of pharmaceutical product or free sale certificate, and stability data supporting standard room-temperature storage. M Care itself holds ISO 9001:2015 quality management certification and a CDSCO export licence; M Care is a merchant-exporter and does not hold WHO-GMP or WHO-PQ certification directly, and every manufacturer's certificate in the pack is issued to the manufacturing site, not to M Care. All 26 lines M Care carries are single-agent oral tablets across 6mg, 12mg, 24mg and 30mg strengths, so a formulary switch from prednisolone needs no combination-product interaction data to source separately. Buyers should confirm destination-country registration status before order, since deflazacort is registered as Calcort or an equivalent brand in many UK, EU and Gulf markets but is not approved for import into the United States, which M Care does not supply.
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.
What a buyer should know before this line enters a formulary.
We publish the awkward facts alongside the useful ones. A supplier who omits them is not saving you work, only deferring it.
Deflazacort tablets are prescription-only medicine (POM/Rx-only) in every market M Care serves; not sold over the counter.
M Care does not supply the United States market for any molecule.
The commonly cited 6mg deflazacort to 5mg prednisolone conversion ratio is a starting-dose estimate from the UK Calcort SmPC (documented potency range 0.69 to 0.89); the prescribing clinician sets the actual conversion for a given patient or protocol, not the supply chain.
Comparative bone-density and glucose-handling evidence for deflazacort versus prednisolone is mixed and trial-specific; it must not be presented to a buyer as a uniform or guaranteed advantage.
Chronic use suppresses the hypothalamic-pituitary-adrenal axis; abrupt withdrawal after prolonged therapy can cause acute, potentially fatal adrenal insufficiency.
Immunosuppression increases risk of new, reactivated or disseminated infection; signs of infection may be masked.
Adjacent lines procurement desks order alongside deflazacort.
Etoricoxib
Another musculoskeletal & pain line ordered on the same formularies.
Febuxostat
Another musculoskeletal & pain line ordered on the same formularies.
Methylprednisolone
Another musculoskeletal & pain line ordered on the same formularies.
All musculoskeletal & pain
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 deflazacort.
- 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.
Deflazacort supply, the specific questions.
Does M Care hold WHO-GMP or WHO-PQ certification directly?
No. M Care Exports is a merchant-exporter, not a manufacturer, and does not hold WHO-GMP or WHO-PQ certification itself. Deflazacort tablets are sourced from WHO-GMP certified Indian manufacturers, and each consignment travels with that manufacturer's own GMP certificate and batch documentation. M Care's own credentials are ISO 9001:2015 certification and a CDSCO export licence.
What is the deflazacort-to-prednisolone dose conversion for a tender or formulary switch?
The UK Calcort Summary of Product Characteristics states that 6mg of deflazacort has approximately the same anti-inflammatory potency as 5mg of prednisolone or prednisone, drawn from a documented potency ratio range of 0.69 to 0.89. A straight 1:1 substitution under-doses; the prescribing clinician, not the supply chain, should set the conversion for a specific patient or protocol.
Is deflazacort's bone-sparing advantage over prednisolone consistent across trials?
No, it is population and duration dependent. A randomized kidney transplant trial found deflazacort preserved lumbar bone density better than prednisone over 78 weeks (3.0% loss versus 9.1% loss), and a juvenile chronic arthritis trial found a significant spinal bone-mineral advantage for deflazacort. A polymyalgia rheumatica trial found the opposite at three months, with deflazacort causing greater bone loss than prednisolone, a difference that closed only by six to twelve months. Procurement teams should treat the bone-sparing claim as trial-specific, not universal.
Does deflazacort's glucose-sparing reputation hold up against prednisolone?
Only partly, and the evidence is ratio dependent. Several older comparisons found deflazacort less diabetogenic than prednisone at anti-inflammatory-equivalent doses, but a study run at a higher 1.5mg-to-1mg deflazacort-to-prednisone ratio found the glucose-tolerance difference between the two drugs narrowed, which its authors attributed to earlier studies using a lower conversion ratio that understated prednisone's equivalent dose, not to a consistent metabolic advantage for deflazacort. Buyers should not present deflazacort to a tender committee as categorically glucose-sparing versus prednisolone.
Which deflazacort forms and strengths does M Care supply?
M Care stocks deflazacort only as oral tablets, in 6mg, 12mg, 24mg and 30mg strengths, across 26 lines. Oral suspension, capsule and injectable deflazacort exist as clinical formulations and are used in some markets, but M Care does not stock or export them; buyers needing a non-tablet route should source that form separately.
Does M Care export deflazacort to the United States?
No. M Care does not serve the United States market for any molecule. Deflazacort is approved in the US as Emflaza specifically for patients age 5 and older with Duchenne muscular dystrophy (FDA approval, February 2017), a narrower indication than the multi-condition use it has across the UK, EU, Gulf, Africa, Latin America, Southeast Asia and CIS markets M Care supplies.
What documentation does M Care provide with a deflazacort shipment?
Each consignment ships with a batch-specific certificate of analysis, the source manufacturer's WHO-GMP certificate, and a certificate of pharmaceutical product or free sale certificate to support destination-country registration. Stability data supports standard room-temperature storage; no cold chain documentation is required.
What is the key safety warning procurement teams should flag for deflazacort?
Like prednisolone and other chronic oral corticosteroids, deflazacort suppresses the hypothalamic-pituitary-adrenal axis with sustained use, and abrupt withdrawal after prolonged therapy can cause adrenal insufficiency. The UK SmPC also flags increased susceptibility to infection, dose-related growth retardation in pediatric long-term use that may be irreversible, and a requirement to avoid live vaccines during periods of impaired immune responsiveness. These are class-wide corticosteroid warnings, not unique to deflazacort.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-08-22.
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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