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India’s leading manufacturer of Sterile Injectables company to soon enter the EU markets with various range of injectables and expand gradually.
Swiss Parenterals Limited, one of the India’s leading sterile injectable manufacturer has received the European Union (EU) GMP for its two state of the art manufacturing facilities located at Bavla in Gujarat. The certification will allow the company to market its product in all the 27 member countries of EU and also give access to European Economic Area (EEA) countries.
The company plans to enter in the EU and EEA with its super specialty niche molecules in sterile injectables segment.
The inspection was carried out in the end February 2020 and first week of March 2020 for both of its site situated in Bavla, Ahmedabad. The final approval received on 31st of July 2020.
The company is currently engaged in manufacturing sterile injectables in both liquid and powder forms and covers a special segment of niche injectables in various dosage like ampoules, vials, lyophilization, pre filled syringe, cartridges, sterile eye drops and expanding soon into liquid inhalation anesthesia, sterile ointment and suppositories. Above this the company is also engaged in contract manufacturing of oral solid dosage including tablets, capsules and other forms from its various vendors.
Mr. Vikram Shah, Managing Director, Swiss Parenterals Limited said. “We are very delighted to receive the EU GMP accreditation for our sterile manufacturing plants and this is an outcome of our great team work, I am thankful to the members of the company who are maintaining the GMP standards”
Mrs Sindhu Marar, Director International Business, said “This approval is very important to us and the stepping stone to increase our international foot print. The company had previously approval of EU GMP on its one of the manufacturing sites along with PIC/s and TGA Australia approval, post which this year company decided to go for EU GMP approval for its both injectables site in Ahmedabad.
Mr Naishadh Shah and Mr Piyush Pandya, Directors who are responsible for the operations said “EU GMP approval is the result of stringent quality and compliance norms followed at Swiss Parenterals across all department and especially in Microbiology and Quality assurance including data compliance.
With the EU GMP approval the company will focus to cater to the niche segment and growing needs of injectables around the world. The company plans to enter along with the EU and EEA now through the Mutual Recognition Agreements (MRA) to various other stringent regulated markets including Brazil, Colombia, Mexico, Australia, New Zealand and South Africa in the first phase.
The company has been operational only in exports and this key approval will help to get a boost in sales worldwide. The company is focusing to develop new molecules year on year basis through its formulation development. Since competition in the injectables domain is less the company also is maintaining a high net profit ratio.
Swiss Parenterals Limited is a third generation, unlisted family run business. The company has strong portfolio in injectables. Company is currently present in 47 countries and this approval will bring a minimum boost of 90 plus countries. Current presence of the company is across Arica, Latin America, South east Asia and Middle east.
The company believes in maintaining a high level of GMP and manufacturing more profitable products at lower production utilization and thus is not currently looking forward to enter domestic markets, and focus on export-oriented growth.
