P. G. Dept of Chemistry, Govt. of Maharashtra's Ismail Yusuf College of Arts, Science and Commerce, Jogeshwari (East), Mumbai-400 060, India
*Corresponding Author E-mail: sawantsudhir@hotmail.com
Online published on 5 June, 2014.
This paper will discuss the various risks and challenges that manufacturers face regarding the manufacturing of polymorphically pure products especially APIs and detailed specific risks during manufacturing in commercial plants and precautions to be taken during manufacturing, quality inspections and also during their product development efforts in R and D. A conscious approach of all personnel involved in manufacturing teams towards ensuring the polymorphic purity of the drug substance is very much essential element for regulated markets and for business continuity of a generic firm.
Polymorphs, drug substance, bioavailability, bioequivalence, dissolution, recrystallisation, XRPD, manufacturing, regulatory agencies, DMF, ANDA
