Category Archives: News and Insights

Sanzyme Biologics performs a systemic review of evidence and publishes a range of health claims for
its flagship probiotic strain Bacillus coagulans SNZ 1969® with FSANZ. Standard 1.2.7 of the Food
Standards Code provides a route for the food industry to self-substantiate a food-health relationship
in order to make a general level health claim. It requires a systematic review demonstrating a causal
association between the food and the health effect.

SNZ 1969® already has USFDA GRAS (Adult & Infant), Health Canada Approval, FSSAI licence and its
manufacturing facility is registered for exports in Japan and China. With the recent claim notification
in FSANZ- SNZ 1969® is well positioned for usability in key probiotic markets across the globe.

Bacillus coagulans SNZ 1969® is backed by 30 human studies and a five-decade history of use
demonstrating its safety and efficacy. SNZ 1969®_ is scientifically studied for gut, oral and women’s
health benefits. Today, it is marketed in over 40 countries across the globe. Being a hardy natural
spore forming probiotic strain, it doesn’t require a cold chain and is used in a range of processed
food and beverage product formats.

Sanzyme Biologics is a pioneer in probiotics and has five decades of expertise in fermentation
technology. Founded in the year 1969 as Uni-Sankyo in joint venture with Sankyo, Japan. It was the
first company to manufacture and sell probiotics under the SPORLAC brand in India. Since then, it
has evolved and transformed into a global leader in shelf and process stable probiotic solutions.

Bacillus coagulans SNZ 1969®, a natural spore forming probiotic strain with five decades history of use and over 30 human studies across age groups found to be effective in managing IBS symptoms, demonstrates the latest clinical study.  This study is unique as it covers both the IBS-D and IBS-C groups with larger number of subjects.

Irritable bowel syndrome (IBS) is one of the most common disorders of gut-brain interaction, estimated to affect around 11% people globally.  The outcome of this study will be significant to supplement manufacturers as it can help design products to address consumer need for managing IBS symptoms with a scientifically studied probiotic strain.

In a randomized, double blind, placebo-controlled study¹, probiotic potential (efficacy and safety) of SNZ 1969® has been studied in patients with constipation predominant irritable bowel syndrome (IBS-C) and diarrhea predominant irritable bowel syndrome (IBS-D).  Reduction in the GSRS-IBS score was greater in the treatment group (39.78%) compared to the placebo group (2.42%). Consistent reductions in the GSRS-IBS score also seen in patients with IBS-D from baseline (62.5±3.9) to day 75 (34.45±3.53) (p<0.0001) after treatment with SNZ 1969®.  The study showed most patients (90%) with IBS-C and 100% with IBS-D responded to SNZ 1969® as compared to no responders treated with placebo, p<0.0001.  SNZ 1969® was found to be safe and effective alternative to therapeutic option for IBS patients as it alleviates IBS-associated clinical symptoms and improves the quality of life as compared to placebo.

This study was conduct at Apollo Hospitals, Hyderabad, India and published in the International Journal of Basic & Clinical Pharmacology.  https://www.ijbcp.com/index.php/ijbcp/article/view/5120

The same strain has been studied earlier for gastrointestinal discomfort, intestinal motility and intermittent constipation among health subjects.  GI discomfort study² showed an improvement in total SODA scores, including specific symptoms such as burping/belching, bloating, heartburn, passing gas, nausea, bad breath, and sour taste compared with placebo.  Intestinal motility³ study concluded that SNZ 1969® reaches the colon intact and ameliorates intestinal motility and gut microbiota composition by enhancing lactobacillales and diminishing synergistales.  With the latest IBS study, the overall digestive health positioning of SNZ 1969® has been bolstered and made SNZ 1969® an ultimate option for food and supplement manufacturers around the globe.

About Sanzyme Biologics

Sanzyme Biologics was incorporated in 1969 as Uni-Sankyo and was the first company to manufacture and sell probiotics in the Indian market.  Over the last five decades Sanzyme Biologics established its strength in probiotics by developing scientifically studied and well-documented probiotic strains, pioneered their applications beyond human health into aqua, veterinary, poultry and bioremediation.  Sanzyme Biologics has market presence in over 40 countries across the globe.

Hyderabad,24^th March 2021, Among various drug and dietary supplement manufacturers and consumers, the Non-GMO project verification seal is the most trusted label, providing assurance that the products has completed a rigorous, unbiased evaluation for compliance with the Non-GMO Project Standard.

After scrupulous testing of its raw material sourcing and manufacturing, Sanzyme Biologics Ltd has achieved NON-GMO certification, strengthening its position as a committed and trusted manufacturer of excellent quality probiotics. All its four major probiotics strains, which are, Bacillus coagulans SNZ 1969^TM, Bacillus clausii SNZ 1971, Bacillus subtilis SNZ 1972 and Saccharomyces boualrdii SNZ 1986 now carry the Non- GMO project verified seal.

Dr. Raunak Soman, Executive Director at Sanzyme Biologics says, “Sanzyme Biologics is a pioneer in biotechnology industry with over five decades of fermentation experience. It is India’s first probiotics manufacturer and has always strived to achieve greater heights in its manufacturing technology. As consumers become more aware and informed about what they consume and are looking for products that are safe, it became imperative for Sanzyme Biologics to acquire the NON GMO seal to reconfirm its commitment to building a transparent and sustainable probiotic manufacturing ecosystem. Sanzyme Biologics is committed to detailed and precise specifications for its probiotics as a quality ingredient.”

Sanzyme Biologics is a 50-year-old biotechnology company based in Hyderabad, India. It specializes in the production of spore forming probiotic bacteria. Sanzyme’s best-studied probiotic product is Bacillus coagulans SNZ 1969™. SNZ 1969 is a well-studied and documented strain with 20+ Clinical Trials and multiple regulatory approvals (FDA GRAS, Infant GRAS, EFSA QPS, Health Canada, FSSAI and others). It is currently sold and used in 30+ countries including USA, Italy, Canada, Australia and Japan.

NON-GMO certification website link:

Please visit the below link and search for Sanzyme Biologics in the search tab

Verified Products – The Non-GMO Project

Sanzyme Biologics has obtained Generally Recognized as Safe (GRAS) approval relating to use of Bacillus coagulans SNZ 1969™ in infant formula.

The US Food & Drug Administration (FDA) issued the company with a GRAS Notice known as a ‘no objection letter’. It states that it has no questions regarding the safety of Bacillus coagulans SNZ 1969™spore preparation marketed by Sanzyme Biologics when used in infant formula

The FDA’s decision means Bacillus coagulans SNZ 1969™spore preparation is permitted for use as an ingredient in a non-exempt infant formula for term infants, at levels up to 2x 10⁸ colony forming units (CFU) per 100 ml infant formula, as consumed.

Bacillus coagulans SNZ 1969™is a Gram-positive, spore-forming, rod-shaped bacterium, which was isolated from green malt in 1949. The SNZ 1969 strain is deposited in the Microbial Type Culture Collection as MTCC 5724 and in the Belgian Coordinated Collections of Microorganism as LMG S – 27484.

Numerous clinical studies where Bacillus coagulans SNZ 1969™ was consumed by both children (including infants) and adults reported no relevant adverse reactions.

Dr. Raunak Soman, Executive Director, Sanzyme Biologics said: “This approval is a significant regulatory milestone and speaks volumes about the quality and safety of our strain.  Probiotics usage has seen a sharp increase over the past few years in infants products, as the babies natural gut flora can be affected by variable factors that can lead to serious life threatening complications. We hope to benefit millions of babies with our Bacillus coagulans SNZ 1969™usage in infant formula. This strain has been used by children in India for decades, with no safety issues or concerns. This history of use and the inherent stability of the strain in food applications make SNZ 1969 the ideal strain for infant applications”

Sanzyme Biologics is a 50 year old biotechnology company based in Hyderabad, India. Sanzyme specialises in the production of probiotic bacteria. Sanzyme’s best studied probiotic product is Bacillus coagulans SNZ 1969™. SNZ 1969 is a well-studied and documented strain with 20+ Clinical Trials and multiple regulatory approvals (FDA GRAS, Infant GRAS, EFSA QPS, Health Canada, FSSAI and others). It is currently sold in and used in 30+ countries including USA, Italy, Canada, Australia and Japan.