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Generic antibiotic industries: Challenges and implied strategies with regulatory perspectives

Ever since the discovery of antibiotics, the quality of human life greatly improved in the 20(th) century. The discovery of penicillin transformed the medicine industry and initiated a search for a better antibiotic every time resulting in several synthetic and semi-synthetic antibiotics. Beginning...

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Detalles Bibliográficos
Autores principales: Venkatesh, M., Bairavi, V. G., Sasikumar, K. C.
Formato: Texto
Lenguaje:English
Publicado: Medknow Publications 2011
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3053506/
https://www.ncbi.nlm.nih.gov/pubmed/21430959
http://dx.doi.org/10.4103/0975-7406.76481
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author Venkatesh, M.
Bairavi, V. G.
Sasikumar, K. C.
author_facet Venkatesh, M.
Bairavi, V. G.
Sasikumar, K. C.
author_sort Venkatesh, M.
collection PubMed
description Ever since the discovery of antibiotics, the quality of human life greatly improved in the 20(th) century. The discovery of penicillin transformed the medicine industry and initiated a search for a better antibiotic every time resulting in several synthetic and semi-synthetic antibiotics. Beginning with the 1937 sulfa drug tragedy, the drug regulations had a parallel growth along with the antibiotics and the antibiotic-based generic Pharma industries. This review article is focused on the scenario depicting current global Pharma industries based on generic antibiotics. Several regulatory aspects involved with these industries have been discussed along with the complexity of the market, issues that could affect their growth, their struggle for quality, and their compliance with the tightened regulations. With the skyrocketing commercialization of antibiotics through generics and the leveraging technologic renaissance, generic industries are involved in providing maximum safer benefits for the welfare of the people, highlighting its need today..
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spelling pubmed-30535062011-03-22 Generic antibiotic industries: Challenges and implied strategies with regulatory perspectives Venkatesh, M. Bairavi, V. G. Sasikumar, K. C. J Pharm Bioallied Sci Invited Review Ever since the discovery of antibiotics, the quality of human life greatly improved in the 20(th) century. The discovery of penicillin transformed the medicine industry and initiated a search for a better antibiotic every time resulting in several synthetic and semi-synthetic antibiotics. Beginning with the 1937 sulfa drug tragedy, the drug regulations had a parallel growth along with the antibiotics and the antibiotic-based generic Pharma industries. This review article is focused on the scenario depicting current global Pharma industries based on generic antibiotics. Several regulatory aspects involved with these industries have been discussed along with the complexity of the market, issues that could affect their growth, their struggle for quality, and their compliance with the tightened regulations. With the skyrocketing commercialization of antibiotics through generics and the leveraging technologic renaissance, generic industries are involved in providing maximum safer benefits for the welfare of the people, highlighting its need today.. Medknow Publications 2011 /pmc/articles/PMC3053506/ /pubmed/21430959 http://dx.doi.org/10.4103/0975-7406.76481 Text en © Journal of Pharmacy and Bioallied Sciences http://creativecommons.org/licenses/by/2.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Invited Review
Venkatesh, M.
Bairavi, V. G.
Sasikumar, K. C.
Generic antibiotic industries: Challenges and implied strategies with regulatory perspectives
title Generic antibiotic industries: Challenges and implied strategies with regulatory perspectives
title_full Generic antibiotic industries: Challenges and implied strategies with regulatory perspectives
title_fullStr Generic antibiotic industries: Challenges and implied strategies with regulatory perspectives
title_full_unstemmed Generic antibiotic industries: Challenges and implied strategies with regulatory perspectives
title_short Generic antibiotic industries: Challenges and implied strategies with regulatory perspectives
title_sort generic antibiotic industries: challenges and implied strategies with regulatory perspectives
topic Invited Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3053506/
https://www.ncbi.nlm.nih.gov/pubmed/21430959
http://dx.doi.org/10.4103/0975-7406.76481
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