Swiss Parenterals, a leading sterile injectables manufacturer has received the European Union (EU) GMP for its two manufacturing facilities located at Bavla in Gujarat. The certification will allow the company to market its product in all the 27 member countries of the EU and also give access to the European Economic Area (EEA) countries.
The company plans to enter in the EU and EEA with its super speciality niche molecules in sterile injectables segment.
The inspection was carried out at the end of February 2020 and the first week of March 2020 for both of its site situated in Bavla, Ahmedabad. The final approval received on July 31, 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 dosages like ampoules, vials, lyophilization, pre-filled syringe, cartridges, sterile eye drops and expanding soon into liquid inhalation anaesthesia, sterile ointment and suppositories. The company is also engaged in contract manufacturing of oral solid dosage including tablets, capsules and other forms from its various vendors.
Vikram Shah, Managing Director, Swiss Parenterals said, “We are very delighted to receive the EU GMP accreditation for our sterile manufacturing plants and this is an outcome of our great teamwork, I am thankful to the members of the company who are maintaining the GMP standards”
Sindhu Marar, Director International Business, said, “This approval is very important to us and the stepping stone to increase our international footprint. The company had previously received the approval of EU GMP on one of its manufacturing sites along with PIC/s and TGA Australia approval, post which this year company decided to go for EU GMP approval for both the injectables sites in Ahmedabad.
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.
Swiss Parenterals is a third-generation, unlisted family run business. The company has a strong portfolio in injectables. It is currently present in 47 countries and this approval is expected to bring a minimum boost of 90 plus countries. The current presence of the company is across Arica, Latin America, Southeast Asia and the Middle East.