Ideal Cures recently received EXCiPACT certification. Suresh Pareek, Managing Director, Ideal Cures talks to Usha Sharma about the recognition and how it will boost the company’s growth
Ideal Cures has recently received EXCiPACT certification for pharmaceutical excipients. What is the significance of this certification for Ideal Cures as well as for your customers?
Ideal Cures is the first Indian company to receive the EXCiPACT certification for manufacture of film coating materials, neutral pellets, Ecocool Extended Cooling Booster, Methacrylic Co-polymers and dispersions and Ethyl Acrylate Co-Polymers. This covers the full range of products manufactured by Ideal Cures. This certification is an ample evidence of the fact that Ideal Cures produces pharma excipients, while maintaining high quality GMP and GDP practices. According to the EXCiPACT, Ideal Cures has yet again shown that it is very sincere about the quality of its products and providing the best products to the customers.
It is an international accreditation and it is going to be an important tool for the customers to repose the trust in the EXCIPACT certified company and eliminate elaborate audits and inspections to consider us a trustworthy vendor with consistent quality for the listed materials.
With our products portfolio, we ensure to achieve the highest standards in regulatory, quality and safety. The EXCiPACT scheme can be made available when the regulators in the EU and the US require the holder of the marketing authorisation for medicines to ensure that appropriate GMP and GDP is applied to the manufacture and distribution of both APIs and excipients. The US Food and Drug Administration and the European Medicines Agency continue to require drug producers to qualify their excipient suppliers appropriately and as a result the suppliers must be prepared to receive increasing numbers of audits from their customers.
EXCiPACT helps to avoid additional audits in a cost-effective manner for all parties concerned because one single audit is all it takes to prove that an excipient complies with current GMP and GDP requirements.
Which manufacturing sites have received the certification and for what?
Ideal Cures has three manufacturing sites at Vasai (Maharashtra), Jammu and Khambhat (Gujarat) and we have already been awarded the certification for Khambhat and Jammu. For the Vasai site, the audit is already done and the recommendations have been forwarded to the EXCiPACT headquarters by SGS and we hope to get the certificate by mid May 2015. We manufacture the tablet film coating materials (Instacoat, Instaspray, Instamodel), acrylic polymers (Ecopol) Cooling boosters (Ecocool), Neutral Spheres/Pellets (Espheres). We are the first Indian company to have achieved this distinction and it shows a symbol of quality.
So far, how many Indian as well as multinational excipient manufacturing companies have obtained this certification? How will this certification differentiate Ideal Cures from other domestic excipient manufacturers?
So far no other Indian company has received this distinction/certification, Ideal Cures has become the first Indian company to receive this certification. A total of 15 multinational organisations have received this certification www.excipact.org/certification/certificates/.
How will EXCiPACT certification impact your exports?
We export our products to 42 countries spread across five continents. This certification encompasses all the regulatory and GMP aspects what the pharma regulators look for. This accreditation will fulfil the basic requirements of the customers so the product evaluation becomes faster and based on the suitability of the material in the customer, products will accelerate the usage and supply. This will be beneficial to both the customers as well as Ideal Cures .Since EXCiPACT is going to be an acceptable certification for highly regulated markets, the acceptance of our materials for use in the products of international drug manufacturers will open up a lot of opportunities.
What is EXCiPACT?
EXCiPACT is a project of the IPEC Federation, a global organisation to promote quality in pharma excipients (see www.ipecfed.org ). EXCiPACT is a voluntary international scheme which provides independent third party certification to manufacturers, suppliers and distributors of pharma excipients worldwide. It ensures patient safety through supplier quality while minimising the overall costs for assessing the excipient supply chain. It was launched in January 2012 since when there has been a considerable interest among pharma excipient suppliers, customers and regulators.
Give us a review of the new products in the Ideal Cures pipeline? Will they be launched in the international markets?
Our new product Instacoat 4G, which is for immediate release film coating, at 35 per cent reconstitution has been launched and is receiving an excellent response. The product reduces process time by more than 50 per cent for normal film coating operations. This saves cost in terms of time and power and machine utilisation can be enhanced. The product is very good for continuous coating and we have already taken successful trial with Thompson machines in Chicago and the product has performed with excellence. So far, Instacoat 4G is the only product with 35 per cent reconstitution level and has excellent coating ability. Apart from this, other products in the existing products range of Instacoat, Instamodel, Ecocool have already been launched. For Espheres, we are having the commercial availability of SiO2 and tartaric acid.
What are the corporate plans for the current financial year?
In April 2015, we have completed the second phase of expansion at Khambhat and the Ecopol manufacturing capacity is enhanced to 400 MT per month. For 2015 – 16, we have plans to expand our Jammu facility for both Instacoat film coating materials and E Spheres (Neutral pellets). Apart from this, we have plans for acquisition of manufacturing units outside India involving an outlay of Rs 50 – 100 crores.
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