scholarly journals Medi-Span Generic Product Identifier

2020 ◽  
Author(s):  
Keyword(s):  
Generic Product

scholarly journals Developing methods to compare tablet formulations of atorvastatin

2012 ◽  
Vol 48 (4) ◽  
pp. 801-810 ◽  
Author(s):  
Marcelo Antonio de Oliveira ◽  
Caroline Dutra Lacerda ◽  
André Fazôlo Bonella
Keyword(s):  
Rotation Speed ◽  
Pharmaceutical Formulations ◽  
Generic Product ◽  
Dissolution Test ◽  
Dissolution Medium ◽  
Differential Dissolution ◽  
Tablet Formulations ◽  
Biopharmaceutical Classification System ◽  
Paddle Apparatus ◽  
The Ideal

Atorvastatin (ATV) is an antilipemic drug of great interest to the pharmaceutical industry. ATV does not appear in the monographs of Brazilian pharmacopoeia, and analytical methodologies for its determination have been validated. The chromatographic conditions used included: RP-18 column-octadecylsilane (250 x 4.6 mm, 5 mm), detection at 238 nm, mobile phase containing 0.1% phosphoric acid and acetonitrile (35:65% v/v), flow at 1.5 mL min-1, oven temperature at 30ºC, and injection volume of 10 mL. ATV is classified as a class II product, according to the biopharmaceutical classification system. As such, a dissolution test was proposed to evaluate pharmaceutical formulations on the market today, under the following conditions: water as a dissolution medium, 1000 mL as a volume, paddle apparatus at a rotation speed of 50 rpm, 80% (Q) in 15 minutes with UV spectrophotometer readings at 238 nm. In the pattern condition proposed as the ideal dissolution test, which appropriately differentiates amongst formulations, the generic product was not considered pharmaceutically equivalent; however, in other less differential dissolution methods, which also fall within appropriate legal parameters, this product could come to be regarded as generic.

Generic product entry in EU markets

2015 ◽  
Vol 4 (3) ◽  
pp. 131-133
Author(s):  
Lorna Brazell
Keyword(s):  
Generic Product ◽  
Product Entry

scholarly journals COMPARATIVE STUDY OF REGULATORY REQUIREMENTS AND REGISTRATION PROCESS OF GENERIC DRUGS IN JAPAN AND CHINA

2018 ◽  
Vol 3 (1) ◽  
pp. 75-87
Author(s):  
Dinesh Chandra Konuri ◽  
Mamillapalli S. ◽  
A. Elphine P. ◽  
Brahma S.R. Desu
Keyword(s):  
Pharmaceutical Industry ◽  
Comparative Study ◽  
Generic Drugs ◽  
Emerging Market ◽  
Generic Product ◽  
Regulatory Requirements ◽  
Registration Process ◽  
Regulated Markets ◽  
Device Agency ◽  
Japan And China

A Generic Product must meet the standards established by Pharmaceutical Medical Device Agency (PMDA) & China Food and Drug Administration (CFDA) to be approved for marketing in Japan and China respectively. This study covers the introduction to generic drugs, and JAPAN & CHINA regulatory authorities. It also includes the requirements and registration of Generic Drugs in above specified countries. It also includes the checklist for comparative study of regulatory requirements and registration process of generic drugs in JAPAN & CHINA. JAPAN and CHINA are two different markets which are important to pharmaceutical industry. Japan is under one of the Regulated markets and owning the world’s second largest pharmaceutical market. Whereas China is under the Emerging market, but unfortunately these two are un trapped markets in the Pharma hub. So, am enthusiastic to know about Regulatory considerations and Registration process of Generic Drugs.

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