Calcium L-5-Methyltetrahydrofolate · the biologically active form of folate
Calcium L-5-Methyltetrahydrofolate: active folate effective in every MTHFR genotype. Made by Molclone Labs, USP 2025, 95–102% assay. From Biontera.
Folic acid ; the synthetic form of vitamin B9 ; must be converted to methylfolate by the MTHFR enzyme before cells can use it. Yet roughly 40–60% of the world's population carries genetic polymorphisms that reduce this enzyme's efficiency; in these individuals, standard folic acid supplements cannot deliver full benefit.
Calcium L-5-Methyltetrahydrofolate (L-Methylfolate) is the active form with the conversion step already complete: it bypasses the MTHFR enzyme, offering direct biological availability in every genotype. The form supplied by Biontera is produced at the US FDA and TİTCK-approved Molclone Labs facility (Chennai, India) in compliance with the USP 2025 monograph, delivered with a 95–102% assay range under WHO-GMP standards.[1]
Folate is the coenzyme at the centre of DNA synthesis, the methylation cycle and homocysteine metabolism. The role of periconceptional folate in preventing neural tube defects rests on one of nutrition science's strongest evidence bases. The MTHFR C677T and A1298C polymorphisms reduce conversion efficiency of folic acid to the active form, creating an "invisible" response heterogeneity in a substantial share of the population.
L-Methylfolate removes that heterogeneity: it enters the blood directly as the active form, requires no conversion, and stays outside the unmetabolised-folic-acid debate. The white to light-yellowish powder is partially water-soluble and fully soluble in basic solutions; it is the new-generation core active for prenatal, women's-health, cardiovascular and neurological-support formulations.
Manufactured to ICH standards at a facility holding Form 25 + Form 28 licences; lot-based CoA, impurity profile and stability data provided in the technical file. Pharmacopoeial compliance analysis
Every shipment can be delivered with a 12-item technical documentation file on request:
Folic acid is a synthetic pro-form that must be converted by the MTHFR enzyme before cells can use it. L-methylfolate is already the active form, delivering direct efficacy in every genotype ; independent of the MTHFR polymorphisms affecting ~40–60% of the population.
Molclone Labs' Chennai facility is approved by the US FDA and Türkiye's TİTCK; production complies with the USP 2025 monograph and WHO-GMP. Every lot ships with a CoA covering assay (95–102%), impurity profile and microbiological analysis.
White to light-yellowish powder; partially soluble in water, fully soluble in basic solution. The calcium-salt form is stabilised against hygroscopicity; storage conditions are specified in the technical file.
Biontera holds exclusive Türkiye distribution of the niche API portfolio including Magnesium L-5-MTHF, Calcium Folinate and Pentosan Polysulfate Sodium.
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