Our Quality Policy

Our Quality Policy is to observe good manufacturing and laboratory practices as laid down in the Indian Drugs and Cosmetic Act, 1940 and Rules, 1945 and as per the British Pharmacopoeia (by International Regulatory Authorities).

This will include (but is not limited to) the following:

1) To observe CGMP, by adopting well defined manufacturing process with in-process controls and necessary requirements such as personnel, premises, plant, safety and validated procedures.

2) Maintaining adequate and competent staff that is well trained in the GMP and GLP aspects.

3) Train the staff and motivate them to follow pre-determined written procedures and maintain records of compliance. To conduct regular quality audits and take corrective actions to streamline systems and maintain desired quality consistency.

4) To observe validated cleaning procedures to ensure thorough cleaning of equipments.

5) To observe good housekeeping and thus avoid mix-up and possible contamination.

6) Conducting stability studies under normal and stress conditions, to ensure stability of the product.

7) Withdrawal products of batches deteriorating during the study.

8) Investigate the cause and take remedial measures.

9) Handling complaints regarding quality & procedures as laid down for investigations and corrective actions.

The above policies and guidelines are based on the GMP standards, laws and regulations covering manufacture of pharmaceuticals to product meets the requirements of safety, identity, potency, strength, quality, purity, uniformity and stability. All members of our technical staff are aware of this quality policy and other details for assurance of quality of our processes and products.

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A Change of Winds in the Nutraceuticals Space

Nutraceuticals are products that range from dietary supplements, isolated nutrients and herbal products. Presently, China is the second largest consumer of Nutraceuticals. It is also the largest producer of Nutraceuticals in the world. South Korea and Australia have joined the race to be part of the growing trajectory in the Nutraceuticals market. Even though India holds only ten per cent of the global market share for Nutraceuticals, it has a definite edge over China dude to better research and quality compliance.

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Industry experts note that, since the world has started backing off from buying food supplements and Nutraceuticals from China due to concerns regarding pollution and quality matters, India is gaining  significant advantage in the global market. Even though the actual annual growth rate of the industry is only around seven per cent,  it is growing at around twenty per cent annually in India. India therefore has a huge potential in the Nutraceuticals segment. Another factor that is adding to the edge of the industry in the country is the addition of thousands of plants that were identified recently in the country to have nutraceutical properties. These new additions hold major potential for the industry at large. A vast Majority of these plants still remain untapped.

On the other hand, ever since the quality standards of Nutraceuticals in the US and Europe have been increasing, China is losing its edge in the market because of pollution and contamination problems that the world at large have come to notice. Presently, China produces ten times the products as India does, but in terms of quality control, India is far ahead of the game. A major reason for the shift of trends is because of the increasing awareness of the side effects of drugs and contamination. This has been re-routing good opportunities in the Nutraceuticals space to India. The general mindset is that we could grow to be a powerful player in this space, if we invest more in research & development and ensure better quality control and accountability from source to shelf.

The current trend in growth of the nutraceutical industry varies widely across the world. The penetration is more in markets such as North America and Europe. These markets also enjoy the high degree of awareness of the consumers as compared to the other markets. The United States is undoubtedly the most active market for nutraceuticals in the entire world. The United Kingdom, Italy, Germany and France are the major markets in Europe.

India, with its treasure trove of plants that have high potential to be used for nutraceuticals  and with industry players with increasing research & development capabilities and higher standards of quality control has set the stage to become a key player in the global nutraceutical space. The future and prospects for Nutraceutical industry in our country seems very promising.

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Bio-gen Product Portfolio – 2013-14

Our Product Portfolio is made of four major product segments.

  • Nutraceuticals (Dietary Supplements)
  • Microencapsulated Oleoresins & Oils
  • Food Ingredients
  • Standardized Natural Extracts

    Bio-gen

Download our Company & Product Brochure here Bio-gen-Brochure

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Active Pharmaceutical Ingredients

Active pharmaceutical ingredients

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Active pharmaceutical ingredient or API is a term for the biologically active component of a pharmaceutical or nutraceutical product These products are usually made up of several components that make up their ‘formulation’. The Active Pharmaceutical Ingredient is the primary ingredient that delivers the desired results when consumed. The other ingredients are called excipients.  These are the substances that are always required make the products biologically safe and safe to consume. These often make up a variable fraction of these products.

The procedure for optimizing the mixture of such components used in the nutraceuticals is known as ‘formulation. If the API is a solid and the drug is required to have a liquid dosage form, such as a cough syrup, then the excipients will then be the liquid/s that are used to formulate the syrup. API molecules have many chemical functional groups. The API form that is used in a formulation is often the most thermodynamically stable crystalline form.  The hydration behavior of crystalline APIs is of particularly high importance within the pharmaceutical industry, and is vastly studied from every closely. The state of hydration has a direct effect on the physical properties of the API, which in turn has a large impact on the way the end-product is processed.  

New Method to Analyze APIs
Recently, a team of scientists in the department of Drug Product Science and Technology, at Bristol-Myers Squibb, USA have developed a supplementary technique to study the behavior of hydration in organic crystalline solids. This complements the more conventional analysis such as calorimetric studies, nuclear magnetic resonance and vibrational spectroscopy.

The team was able to gain more insights be performing single crystal X-ray diffraction experiments with the objective of being interpretation of the non-Bragg diffraction features, Chan et al, 
Acta Cryst. (2014). They were able to gain further insight into the mechanical and structural details of dehydration of the crystal. The scattering features were reproduced and studied using computer models and the results were able to show the mechanistic relationships between changes in the lattice structure as stages of the overall drying process. This is a first of its kind study to combine the mechanism of dehydration and non-Bragg scattering from a single API crystal.  The results will improve the knowledge, formulation and choice of API used in the manufacture of neutraceuticals.

New Guidelines
The APIC of ‘Active Pharmaceutical Ingrediencts’ Council has a new guide on meeting the WHO and European Union Guidelines.The guide deals with various aspects such as Storage, Cleaning and others. Find it here . 

API’s are one of the leading segments in the global nutraceutical market. With emerging technologies and new research, there seem to be more challenges and opportunities for anyone dealing with APIs. Watch this space for more on the latest in APIs.

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Opportunities in the Dietary Supplements in India

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Indian Dietary Supplements Market has offered a lot of opportunities for new and existing players over the last several years. There has been opportunities by way of new gaps in the market and also need for new alternatives for traditional therapeutic applications. Pharmaceuticals, FMCG companies and a very few nutraceutical products companies constitute the Indian nutraceutical market . The general increase in health consciousness and improved incomes and living standards have promoted the growth of these markets in India. It is also one of the fastest growing segments in the country and has shown a continuous growth that does not seem to be affected by the economic downturns or rising inflation.

The country has taken to sports and fitness like never before. Sports Nutrition continues to be another promising market in the country. Protein supplements in particular have become popular in the last few years in this niche. This has also attracted foreign brands into the market through sever collaborations and partnership arrangements.  The interesting aspects that have fueled the growth in this segment are the many changes that have occurred in the spending habits of the urban population. This demographic has become more health conscious than ever before. Gyms and health clubs have also contributed to the growing demand of supplements & vitamins. The nutraceuticals market in 2010 grew by 26.95% compared to 2009. Even though the industry showed a positive trend, 2008 and 2009 saw low sales volumes. Also, the turnover of the industry was low although there was a positive trend fueled by an aging population and increasing chronic diseases. The industry has grown at a CAGR of 18.90% from 2006-2010. The areas that offer great opportunities so far are Urban consumers who make up for 67% of the vitamin and dietary supplement market and  a major share held by herbal food products and supplements; followed by functional digestives.
 
An enormous opportunity exists for anyone who wants to create products for niche markets targeted at specific demographics within the sports nutrition or therapeutic supplements as long as one can educate the end user about the products applications and benefits without having to depend on medical or fitness practitioners. This can be done in many ways, one way would be to be able to build a culture and following around a niche product that is built for a responsive niche community of consumers defined by a specific common personal fitness or health goal. The effort needs to be one that educates the consumer and aids them in their personal fitness or health goals and not simply push products onto them. A great understanding of what the identified community cares about goes a long way in building resources for them and positioning your product in their lives. Bio-gen offers a range of services including new formulations, custom formulations, new products, testing, clinical trials and also fully transparent processes. We make it a point to not only be your reliable partner for ingredients and formulations but also your partner in exploring new Opportunities that help you grow your business.
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Our Stall at Vitafoods Europe 2014

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We showcased Carotenoids along with our other major product categories – Nutraceuiticals, Natural Extracts, Microencapsulated Oleoresins, Oils & Food Ingredients.

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