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INTERNATIONAL JOURNAL OF CREATIVE RESEARCH THOUGHTS - IJCRT (IJCRT.ORG)
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ISSN Approved Journal No: 2320-2882 | Impact factor: 7.97 | ESTD Year: 2013
Call For Paper - Volume 12 | Issue 6 | Month- June 2024
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Published Paper Details:
Paper Title
Generic Drug Approval Process Of India, Japan, USA
Authors
Sakshi S. More, Tejashri S. Zete, Sakshi M. Ghoderao, S. R. Sanap
Keywords
US-FDA, India, Japan, ANDA, Regulatory Approval Processes
Abstract
A regulatory process by which a person gets authority to launch a drug in the market, is known as drug approval process. ANDA is an application for a US generic drug approval for existing licensed medication or approval drug. Drug analyst in regulatory agencies around the world keep up the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of new drug product to serve the public health. Every country has it's own regulatory authority, which is responsible to implement the rules & regulations and issue the guidelines to regulate the marketing of the drug. This article focus on the drug approval process in different Countries like India, Japan and US -FDA.
IJCRT's Publication Details
Unique Identification Number - IJCRT23A5246
Paper ID - 238364
Page Number(s) - k453-k459
Pubished in - Volume 11 | Issue 5 | May 2023
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Publisher Name - IJCRT | www.ijcrt.org | ISSN : 2320-2882
E-ISSN Number - 2320-2882
Cite this article
Sakshi S. More, Tejashri S. Zete, Sakshi M. Ghoderao, S. R. Sanap, "Generic Drug Approval Process Of India, Japan, USA", International Journal of Creative Research Thoughts (IJCRT), ISSN:2320-2882, Volume.11, Issue 5, pp.k453-k459, May 2023, Available at :http://www.ijcrt.org/papers/IJCRT23A5246.pdf
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ISSN: 2320-2882 Impact Factor: 7.97 and ISSN APPROVED Journal Starting Year (ESTD) : 2013
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ISSN: 2320-2882 Impact Factor: 7.97 and ISSN APPROVED Journal Starting Year (ESTD) : 2013
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