Pharmaceuticals and Life Sciences Presentation

1. http://www.vivanls.com/

2. Introduction • About us • Vision and mission • Product Explanations • Documents required according to FDA rules • Who should be the contact person? • Companies • Plan of Action • Sample letter

3. ABOUT US • end level products in Pharmaceuticals andLife Sciences. • We provide break through collaboration for the niche pharmaceutical products, which enhance the capability and productivity performances of our customers and Business Associates, in functions critical to their success. • We stand to lead our Business operations, through innovation, creativity and progressiveness with methods, technologies and operating practices. • In the process of achieving excellence in our services, we believe that quality deliverance is an imperative in every aspect of our Business Process, for a 'Superior Customer Satisfaction'. VIVAN Life Sciences is Knowledge based innovative enterprise, offering higher

4. Vision:To become a highly respectful, knowledge driven innovative Global enterprise, in Pharmaceuticals and Life Sciences. products, and be a Global player in improving the quality of Human life. Our efforts will be to serve humanity with the power of all the scientific knowledge available to us. Our vision sets out the framework and objectives for the future, and directs every one in the organization towards achieving the set goals. Our aim is to be a growing company, driven by experiencing the true sense of self-respect with a high level of integrity. Our value system, in congruence with our expertise and radical ways of operations, has conceptualized and strengthened our taken stand, for the vision and goals at every step of our business process. We believe in creating 'the change', and embracing and adopting the same to the best of its advantage. Creative translation of 'Innovative Ideas' with a vision of 'Powerful Future' is our ambition. We stand for the ‘Leadership Position Of Excellence’ for our quality • • • • •

5. Mission: • To find fulfilment at every step, by continually improving the quality of human life. • To be a successful Global Company, by enabling People and Businesses to realize their full potential. • To build integrity, fairness with high performance in what ever we do, and be a respected corporate citizen.

6. Mission Statement Explanation We standby our statement, and will achieve our mission by: • Focusing on ‘Quality Deliverance’ as the core competency of our business process • Being a ‘Customer Centric Organization’, with continuous value addition • Enrolling every employee (we call them Associates), in to the possibility of Organization’s Mission, and by respecting each individual’s dignity • Providing an open work environment with transparency, each individual is encouraged to implement his or her innovativeness in to creative pursuits • Practicing entrepreneurial style of functioning, we stimulate the idea of self-expression in to the process of our activity • Embracing ' Continual Improvement ' as a practice, in all our Business operations • Nurturing 'Breakthrough ideas' with our 'Industry wisdom' and delivering the best possible solution through our 'Knowledge Management' • Holding the true sense of self-respect in what ever we do, both in terms of an individual Associate and Organization as a whole Above all, we measure our success in terms of the positive contributions, we have made in the lives of people

7. Products Explanation Metabolites: Metabolites are the intermediate products that are formed while the metabolic reactions takes place to form the final product Example : 4-Hydroxypropranolol Hydrochloride Metabolite of : Propranolol Uses: Propanolol Hydrochloride is a beta- adrenergic receptor blocking agent ( Usually used in the management of hypertension drugs) Deuterium Labelled compounds : These come under stable labelled Isotopes • Deuteration has no effect on biological potency or selectivity • Potential for drug to have longer half life and reduced/less frequent dosing • Improve metabolite profile : prevent formation of toxic metabolites Example : (+/-)-4-Hydroxy Propranolol-d7 Hydrochloride It is a labelled metabolite of Propanolol

8. Products Explanation Glucuronides: A glucuronide, also known as glucuronoside, is any substance produced by linking glucuronic acid to another substance via a glycosidic bond. The glucuronides belong to the glycosides. Example:(R)-Propranolol β-D-Glucuronide Sodium Salt Metabolite of: Propanolol Uses: Rac Propranolol β-D-Glucuronide Sodium Salt is a metabolite of Propranolol. Propanolol is a non-selective beta blocker - it blocks the action of epinephrine and norepinephrine on β1-AR and β2-AR (β1- and β2- adrenergic receptors, respectively). Research has also shown that propranolol has inhibitory effects on the norepinephrine transporter and/or stimulates norepinephrine release.

9. Products Explanation Impurities: Impurities are substances inside a confined amount of liquid, gas, or solid, which differ from the chemical composition of the material or compound. Impurities are either naturally occurring or added during synthesis of a chemical or commercial product. Example:(1S)-3-methyl-1-[2-(piperidin-1-yl)phenyl]butan- 1-amine. N-acety • • •

10. Impurities Explanation Impurities are classified as : • Organic impurities • Inorganic impurities • Residual Solvents Organic impurities may arise during the manufacturing process and/or storage of the new drug substance. They may be identified or unidentified, volatile or non-volatile and include: • Starting materials • By-Products • Intermediates • Degradation Products • Reagents, Ligands and catalyst

11. Impurities Explanation Inorganic impurities may derive from the manufacturing process. They are normally known and identified and include: • Reagents, Ligands and Catalysts • Heavy Metals • Inorganic Salts • Other materials (e.g. Filter Aids, Charcoal etc.)

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