DRA

A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.

About Author:
Balbir Singh Negi
GM Regulatory Affairs
SHAH TC Overseas Private Limited, Delhi, INDIA
22 years of industrial Exp,
M.Sc, MBA, Doctor of Science.

Abstract:
The usage of solvents in active pharmaceutical ingredients (API) and coating plants are very common in pharmaceutical industry. The organic solvents are mostly used in washing of product, cleaning of equipments and the reaction media for separation and purification. The cost reduction of the API products can be reduced by the distillation of mother liquor after establishing of yield in R &D, pilot plant and then in the commercial plant, the next process step is validation, done with fresh solvent of three consecutive batches and then done with three consecutive batches of recovered solvents from mother liquor. The product cost is mainly reduced by the distillation of product mother liquor or to do more research to reduce the quantity of solvent or manufacturing process without solvent.

Article By,
Balbir Negi
GM Regulatory Affairs
SHAH TC Overseas Private Limited, Delhi, INDIA
22 years of industrial Exp,
M.Sc, MBA, Doctor of Science.

Crystallization has the vital role in the pharmaceutical industry as it is started from intermediates separation process and the final manufacture step as active pharmaceutical ingredients (APIs).
Crystallization is a key component of almost all processes in the manufacturing of pharmaceuticals. Whether for purification of intermediates, formation of the product, or prevention of crystallization in amorphous products, crystallization is essential in both processing and development.

Crystallization can be natural or artificial process of formation of solid crystalsprecipitating from a solutionmelts or more rarely deposited directly from a gas.

A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.

About Authors:
Geetanjali Sengar*, Pranab Tripathy
Drug Regulatory Affairs Dept.
Belco Pharma, 515, Modern Industrial Estate,
Bahadurgarh-124507(Haryana), India.
*geetanjali.sengar@gmail.com, geetanjalisengar87@gmail.com

ABSTRACT:
As the pharmaceutical industries throughout the world are moving ahead towards becoming more and more competitive, regulatory agencies are being established in various countries across the globe. Regulatory agencies and organizations play a vital role to meet the requirements of legal procedures related to drug development process in a country.

In the present scenario, pharmaceuticals are considered as the most highly regulated industries worldwide. The regulatory body ensures compliances in various legal and regulatory aspects of a drug. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate drug development process,licensing, registration, manufacturing, marketing and labeling of pharmaceutical products. USFDA(USA), MHRA(UK), TGA(Australia), CDSCO(India), HEALTH CANADA(CANADA), MCC(South Africa),ANVISA (Brazil) , EMEA (European Union), SFDA (China),NAFDAC(Nigeria), MEDSAFE(Newzeland), MHLW(Japan), MCAZ(Zimbabwe), SWISSMEDIC(Switzerland), KFDA(Korea), MoH (Sri Lanka) are the few regulatory  agencies and organizations established in respective countries.

AKUMS DRUGS & PHARMACEUTICALS LTD is one of the most innovative, productive and research based pioneer organization of India having its registered office at Delhi and various plants in Haridwar, Uttrakhand giving employment to more than 2000 peop

B S Patel Pharmacy College   offers four year B Pharm Degree programme at the undergraduate level with intake of 60 every year..

Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support.

Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support.