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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO .....FOR BLOG HOME CLICK HERE

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ORGANIC SPECTROSCOPY

Read all about Organic Spectroscopy on ORGANIC SPECTROSCOPY INTERNATIONAL 

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DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK LIFE SCIENCES LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 30 PLUS year tenure till date June 2021, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 90 Lakh plus views on dozen plus blogs, 233 countries, 7 continents, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 33 lakh plus views on New Drug Approvals Blog in 233 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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Innovative Regulatory Review Practices for Better Efficiencies- The Singapore Experience


Republic of Singapore

Republik Singapura  (Malay)
新加坡共和国 (Chinese)
சிங்கப்பூர் குடியரசு (Tamil)
Flag Coat of arms
Motto: 
“Majulah Singapura” (Malay)
“Onward, Singapore”

Innovative Regulatory Review Practices for Better Efficiencies- The Singapore Experience

by

Dr Daniel Tan
Director
Health Products Regulation Group
Health Sciences Authority

read all this at

http://www.who.int/medicines/areas/quality_safety/regulation_legislation/icdra/WH-1_2Dec.pdf

overview

Mission
Background

Regulatory Principles

Evaluation Routes
Data Requirements
Regulatory Process
Application Statistics

Pre-market Evaluation
Depth of evaluation varies following a risk-
& confidence-based approach
Three evaluation routes allowing flexibility
yet ensuring robustness in the registration
system
In-house capabilities complemented by
external experts and advisory committee

Conclusion
Resources are always limited in most regulatory agencies
Adopting a risk based approach to triage drug applications
Titrate the evaluation workload by levaraging on reference agencies
assessment reports
Managing Access to important medicines without prolonging
timelines
For small markets like Singapore, this unique system of drug evaluation,
ensures that market entry of drug products is vetted in an efficient manner
without compromising on stringent standards for safety and efficacy.

SINGAPORE-HSA DRUG APPROVALS


 

SINGAPORE-HSA DRUG APPROVALS

 

Nexium Tablet

Active Ingredient: esomeprazole
Licence Holder: AstraZeneca Singapore Pte Ltd
Date of Approval: 28 May 2013

20MG & 40MG Indications: Patients requiring continued low dose aspirin

 

Galvus Met Tablet

Active Ingredient: vildagliptin/metformin
Licence Holder: Novartis (Singapore) Pte Ltd
Date of Approval: 22 May 2013

50MG/500MG, 50MG/850MG & 50MG/1000MG Indications: For patients with Type 2

Galvustablet

Active Ingredient: vildagliptin
Licence Holder: Novartis (Singapore) Pte Ltd
Date of Approval: 22 May 2013

50MG Indications: Galvus is indicated as an adjunct to diet

Firmagon Powder & Solvent for Solution for Injection

Active Ingredient: degarelix
Licence Holder: Ferring Pharmaceuticals Pte Ltd
Date of Approval: 13 May 2013

120MG & 80MG Indications: FIRMAGON® is a gonadotrophin releasing hormone

Votrient Tablet

Active Ingredient: pazopanib
Licence Holder: GlaxoSmithKline Pte Ltd
Date of Approval: 10 May 2013

200MG & 400MG Indications: Soft tissue sarcoma (STS) VOTRIENT is indicated

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