New Drug Approvals

Home » SINGAPORE

Category Archives: SINGAPORE

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

Paypal donate

Blog Stats

  • 1,444,162 hits

Flag and hits

Flag Counter

Enter your email address to follow this blog and receive notifications of new posts by email.

Join 1,870 other followers

Follow New Drug Approvals on WordPress.com

Categories

Flag Counter

ORGANIC SPECTROSCOPY

Read all about Organic Spectroscopy on ORGANIC SPECTROSCOPY INTERNATIONAL 

Enter your email address to follow this blog and receive notifications of new posts by email.

Join 1,870 other followers

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 PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 29 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 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 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 29 year tenure till date Aug 2016, Around 30 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, 25 Lakh plus views on dozen plus blogs, 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 13 lakh plus views on New Drug Approvals Blog in 212 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

Personal Links

Verified Services

View Full Profile →

Categories

Flag Counter

Guidance on Medicinal Product Registration in Singapore


 

Singapore Government

Singapore Drug Registration Information and Guidelines

Guidance on Medicinal Product Registration in Singapore

– See more at:

http://worlddrugtracker.blogspot.in/2013/09/guidance-on-medicinal-product.html

Advertisements

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

Menarini launches premature ejaculation drug in Singapore


File:Dapoxetine Structural Formulae V.1.svg

DAPOXETINE

Menarini has launched dapoxetine for premature ejaculation in Singapore, having recently published a survey highlighting the rising problem of sexual dissatisfaction in the Asia-Pacific region.

The Italian drugmaker acquired Priligy (dapoxetine)from Johnson & Johnson last year and the drug is now approved in over 50 countries. It estimates that PE affects 34% of men in Singapore at some point in their lives.

READ  ALL AT

http://www.pharmatimes.com/Article/13-07-19/Menarini_launches_premature_ejaculation_drug_in_Singapore.aspx

Dapoxetine, marketed as Priligy (among and other brands) is the first compound developed specially for the treatment of premature ejaculation (PE) in men 18–64 years old.Dapoxetine works by inhibiting the serotonin transporter, increasing serotonin’s action at the post synaptic cleft, and as a consequence promoting ejaculatory delay. As a member of selective serotonin reuptake inhibitor (SSRI) family, dapoxetine was initially created as an antidepressant. However, unlike other SSRIs, dapoxetine is absorbed and eliminated rapidly in the body. Its fast acting property makes it suitable for the treatment of PE but not as an antidepressant.[3]

Originally created by Eli Lilly pharmaceutical company, dapoxetine was sold to Johnson & Johnson in 2003 and submitted as a new drug application to the Food and Drug Administration (FDA) for the treatment of PE in 2004. Dapoxetine has been sold in several European and Asian countries, and lately in Mexico. In the US, dapoxetine is in phase III development and expected to be marketed soon. In 2012, Menarini acquired the rights to commercialise Priligy in Europe, most of Asia, Africa, Latin America and the Middle East.

Premature ejaculation

Randomized, double blind, placebo-controlled trials have confirmed the efficacy of dapoxetine for the treatment of PE. Different dosage has different impacts on different type of PE. Dapoxetine 60 mg significantly improves the mean intravaginal ejaculation latency time (IELT) compare to that of dapoxetine 30 mg in men with lifelong PE, but there is no different in men with acquired PE. Dapoxetine, given 1–3 hours before sexual episode, prolongs IELT, increases the sense of control and sexual satisfaction in men of 18 to 64 years of age with PE. Since PE is associated with personal distress, interrelationship difficulty, dapoxetine provides help for men with PE to overcome this condition.Because lack of specific approval treatment for PE in the US and some other countries, other SSRIs such as fluoxetine, paroxetine, sertraline, fluvoxamine, and citalopram have been used as off label drugs to treat PE. Waldinger’s meta analysis shows that the use of these conventional antidepressants increasing IELT from two to ninefold above base line in comparison of three to eightfold when dapoxetine is used. However, these SSRIs must be taken daily in order to achieve meaningful efficacy, and the long half-life increases the risk of the drug accumulation and as a consequence increased of adverse effects such as decreasing sexual libido and causing erectile dysfunction. Dapoxetine, on the other hand, is a fast-acting SSRI. It is rapidly absorbed and eliminated from the body within a few hours. This favorable pharmacokinetics minimizes the risk of the drug’s accumulation in the body, and therefore reducing side effects.

%d bloggers like this: