New Drug Approvals

Home » COMPANIES » Biocon’s Rosuvastatin Calcium tablets get EU approval to treat hyperlipidemia

Biocon’s Rosuvastatin Calcium tablets get EU approval to treat hyperlipidemia

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

PAYPAL DONATIONS

ORGANIC SPECTROSCOPY

Read all about Organic Spectroscopy on ORGANIC SPECTROSCOPY INTERNATIONAL 

Categories

Blog Stats

  • 1,305,011 hits

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

Join 1,778 other followers

add to any

Share

 

Biocon’s Rosuvastatin Calcium tablets get EU approval to treat hyperlipidemia
Indian biopharmaceutical company Biocon has received approval from the European Commission for its Rosuvastatin Calcium tablets to treat hyperlipidemia or mixed dyslipidemia.

http://www.pharmaceutical-technology.com/news/newsbiocons-rosuvastatin-calcium-tablets-gets-eu-approval-to-treat-hyperlipidemia-4811839?WT.mc_id=DN_News

Indian biopharmaceutical company Biocon has received approval from the European Commission for its Rosuvastatin Calcium tablets to treat hyperlipidemia or mixed dyslipidemia.

Hyperlipidemia is a common genetic disorder that increases lipids and/or lipoproteins levels in the blood.

The first generic formulation approval will allow Biocon to sell Rosuvastatin Calcium 5mg, 10mg, 20mg and 40mg tablets in more than 15 European countries, starting in fiscal 2017.

“This approval paves the way for Biocon to launch Rosuvastatin Calcium tablets in several European countries.”

The company plans to collaborate with regional partners to market the drug; a generic equivalent of Crestor tablets.

Biocon chairperson and managing director Kiran Mazumdar-Shaw said: “This is indeed a proud moment for Biocon’s Small Molecules business.

Biocon chairperson and managing director Kiran Mazumdar-Shaw

“This approval paves the way for Biocon to launch Rosuvastatin Calcium tablets in several European countries.”

The approval will allow the company to address the $1.2bn opportunity in the EU. It will also make it easier for the company to market its products in emerging markets, where regulatory clearances are primarily based on approvals given by regulators in the US / EU.

Biocon was the first generic company to receive a certificate of suitability (CEP) for Rosuvastatin Calcium API from the European Directorate for the Quality of Medicines (EDQM).

CEP certification indicates that an API is suitable for use in medicinal products in the EU.

Biocon CEO and joint managing director Dr Arun Chandavarkar said: “The European approval for Biocon’s generic version of Rosuvastatin Calcium underscores Biocon’s unique strengths in the chronic therapies space and our compliance with global standards that enable us to achieve the highest quality standards for all our products.

“It augurs well for this nascent business, which will be one of our growth drivers in the coming years.”

The company plans to boost its generic formulations business with a target of 20-25 filings over the next few years.

Additionally, Biocon is developing a new facility in Bengaluru, in the Indian state of Karnataka, where it will produce oral solid dosage formulations.

Biocon CEO and joint managing director Dr Arun Chandavarkar

 

 

/////////


Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

Paypal Donate

DR ANTHONY CRASTO

Follow New Drug Approvals on WordPress.com

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

Join 1,778 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

View Full Profile →

TWITTER

bloglovin

Follow my blog with Bloglovin The title of your home page You could put your verification ID in a comment Or, in its own meta tag Or, as one of your keywords Your content is here. The verification ID will NOT be detected if you put it here.
%d bloggers like this: