SEETHARAM KANDARPA
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Tag: ANDA
New Requirements of the FDA on Stability Testing of Generic Drugs
https://seetharamkandarpa.webnode.in/news/new-requirements-of-the-fda-on-stability-testing-of-generic-drugs/
FDA Guide on Import of Drugs prior to approval
https://seetharamkandarpa.webnode.in/news/fda-guide-on-import-of-drugs-prior-to-approval/
"Reception denied!" - the new FDA "Refuse-to-Receive" Guidance for Generics Applications
https://seetharamkandarpa.webnode.in/news/reception-denied-the-new-fda-refuse-to-receive-guidance-for-generics-applications/
ANDA Checklist for Completeness and Acceptability
https://seetharamkandarpa.webnode.in/news/anda-checklist-for-completeness-and-acceptability/
US FDA Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products and FDA Questions and Answers
https://seetharamkandarpa.webnode.in/news/us-fda-guidance-for-industry-andas-stability-testing-of-drug-substances-and-products-and-fda-questions-and-answers/
Mylan launches atovaquone & proguanil hydrochloride tablets
https://seetharamkandarpa.webnode.in/news/mylan-launches-atovaquone-proguanil-hydrochloride-tablets/
USFDA Guidance on "ANDA Submissions- Refuse-to-Receive Standards" Effective from 26 May 2015
https://seetharamkandarpa.webnode.in/news/usfda-guidance-on-anda-submissions-refuse-to-receive-standards-effective-from-26-may-2015/
FDA publishes revised MAPP, ANDA Suitability Petitions (5240.5)
https://seetharamkandarpa.webnode.in/news/fda-publishes-revised-mapp-anda-suitability-petitions-5240-5/
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About Me
SEETHARAM KANDARPA
Seetharam Kandarpa Receives ASQ-Certified Manager of Quality/Organizational Excellence
Web Series 2 of ASQ CQA Mentoring Class: Auditing Fundamentals on 30 July 2017
Overview of ASQ Certified Pharmaceutical GMP Professional (CPGP)
Web Series Session 1: Overview of ASQ Certified Quality Auditor conducted on 21 May 2017
Register to Join Mentoring Class for ASQ-CQA
Mentoring Class for ASQ-CQA
G.ONE (GMP-ONE)- One Spot for all GMP Links required in our JEEVAN
Seetharam Kandarpa Receives ASQ Quality Auditor
Seetharam Kandarpa Receives ASQ-Certified Pharmaceutical GMP Professional
ISO 9001: 2008 Quality Management Systems – Requirements
My new Mobile Application "SRK GCP World"
MACO Calculation Sheet in Cleaning Validation
My new Mobile Application "SRK GMP Videos"
"SRK CLEANING VALIDATION"- My new mobile application
"SRK GMP OCEAN"- My Mobile Application Works for Android & HTML5
"SRK GMP FAQ"- My new Mobile Application
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