Blogs

What are Nutraceuticals and Supplements?

Invented by Dr. Stephan DeFelice in 1989, Nutraceutical is amalgamation of  “Nutrition” and “Pharmaceutical”, so is its function. As per FDA, a  nutraceutical is any substance that is food or part of a food that has medical and  health benefits. They prevent and treat diseases. Generally, nutraceuticals are  used to treat single vitamin/mineral deficiency. When a product is used to treat  multiple deficiencies, it is generally referred as Dietary Supplements.

Potential Health Benefits...

Over the past several years, Nutraceuticals have attracted considerable interest  from masses all over the world, due to their potential in treating/preventing  diseases, safety and therapeutic effect. The products falling under the category  of nutraceuticals have a role in plethora of biological processes, antioxidant  defenses, cell proliferation, gene expression, and safeguarding of mitochondrial  integrity. Nutraceuticals also exhibit disease modifying indications related to  oxidative stress including allergies, cardiovascular diseases, eye conditions,  obesity, and various others.

The timeline to manufacture nutraceuticals and dietary supplements vary  depending upon the packing, the composition of salts and the customization for  the said market required. Generally, the manufacturing process from start to  reach the market for its customers is divided into 10 main steps which are explained below

Step 1- The formula that needs to be manufactured, needs to conform with the  state and central guidelines, in India. It also varies depending upon the end customer if they are male, female or kids. The age group is also a factor to  finalize the formulation. The correct dose of the product has efficient results in the market.

Step 2- Selection of raw materials that are required in the manufacturing is the  next step. Choosing a well-researched raw material cannot promise initial sales  but will likely to offer consistent sales once the product enters the market. Bioavailability, high potency and costings are the major factors in choosing the right raw material.

Step 3- Pricing out the formulation is followed once the raw materials are  finalized. These are subjected to vary depending upon the raw material, packing  material availability and time required in procuring the said material. Once the manufacturing cost is finalized, the retail price is also decided depending upon the margins that need to be kept aside.

Step 4- Once the costing part is finalized, the purchase order is generated with  the manufacturer and final process starts. The generation of the purchase order  confirms the order and the final manufacturing process starts. It usually takes between 2-6 weeks depending upon the availability.

Step 5- Once the order is received, the manufacturer contacts the shortlisted vendors for the raw material and they are procured for the nutraceutical in designated environment and conditions.

Step 6- After the raw material received, they are further tested and quantified in the in-house laboratory to conform to mentioned standards as per the vendor.  Generally, the testing involves identification, potency, microbiological compliance, and heavy metal compliance.

Step 7- Test batch is prepared once the raw material pass the quality checks. This batch is further passed to check, how the final product will look, taste,  smell and will feel to the end user. If any changes are required, it is modified accordingly and tested again.

Step 8- After getting a go ahead for the test batch, pilot batch is prepared for the final preparation in bulk or as per minimum order quantity that has been agreed upon.

Step 9- Final product testing is taken place at this step and the product is almost  in final stages for the end user consumption. Content stability, storage stability  and uniformity are done at this stage. Microbiological compliances are also checked at this stage.

Step 10- A Certificate of Analysis (COA) report is being made at the end, to  ensure the quality of the ready product and to maintain the record of the  manufactured product. Incase of any issue with the product the COA comes handy in knowing what went wrong and where.This is how the manufacturing process of Nutraceuticals and Supplements takes place in a plant or in bulk.