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Claris Lifesciences Limited

Claris Lifesciences Receives MHRA Approval for New Plant

Aug 21, 2014 22:54 IST 
India

Claris Lifesciences Limited (Company) has today announced it has received the MHRA approval for its newly commissioned plant (Plant 2). This will help in enhancing capacities to grow in the regulated markets, especially the European Union. The Company's specialty injectables business saw a growth of 30% in the last quarter.

 

As on 30th June 2014, the company had approvals of 13 ANDAs in US, 14 molecules in the Europe and 11 molecules in Other Regulated Markets (ORM), additionally, there are 28 ANDAs in the US, 8 molecules in Europe and 10 molecules in ORM, which are filed and awaiting approval. The company is currently functioning at high capacity utilization and is adding capacities in Plant 2 to service future demands. To sustainably grow, attaining the required regulatory approvals is one of the key growth drivers; and the company has a large pipeline of products; which includes the under approval and the products currently under development.

 

The Company's flagship plant (Plant 1) is already approved by MHRA-UK. This is the first regulatory inspection and compliance approval conducted by MHRA-UK in line with the EU GMP regulations for Plant 2, this approval is for Terminally Sterilized products presented in glass ampoules manufactured in Line 1 of the Plant 2.

 

The company has plans to install another line in this new plant (Plant 2) which will be ready for commercial production by the end of this year. The existing line has capabilities to manufacture Aseptic Sterilized products as well, and the new line will have the capability to manufacture Lyophilized Products.

 

About Claris Lifesciences Limited:

Claris Lifesciences Limited (BSE Code: 533288) is one of the largest sterile injectables pharmaceutical companies in India. The company manufactures and markets products across various therapeutic segments including Anesthesia, Plasma Volume Expanders, Blood Products, Parenteral & Enteral Nutrition, Infusion therapy, Anti-infective and Renal Care. A significant majority of these products are generic drugs that are capable of being directly injected into the human body and are predominantly used in the treatment of critical illnesses.

 

The company has 3 manufacturing plants; at its campus on the out skirts of Ahmedabad. With emphasis on Quality, Technology & Innovation, Claris offers a range of niche technology-driven injectable products across delivery systems such as glass bottles, glass vials & ampoules, and non­PVC/PVC bags. Claris' sterile injectables facilities have been approved by regulatory authorities including USFDA, MHRA (UK), TGA (Australia), and GCC FDCA. The company's manufacturing capabilities have several times received awards from prestigious institutions like Frost & Sullivan and IDMA.


 
 
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