IDEAL CURES becomes the First Indian Excipients Company to receive EXCiPACT™ Certification
Mumbai, 4th May, 2015
IDEAL CURES PVT. LTD. is well known in the pharmaceutical excipients industry for a long time. IDEAL CURES PVT. LTD. becomes the first Indian company to receive EXCiPACT™ certification for its two manufacturing sites one at Jammu for film coating materials (INSTACOAT™, INSTANUTE™, INSTASPRAY™ and INSTAMASK™), Specialty products (Ecocool Extended Cooling Boosters - ECOCOOL™) and Neutral Spheres- ESPHERES™. Second certification is received for manufacturing site at Khambhat for methacrylic acid co-polymers (ECOPOL® L30 D55, L100 and S100).
Audit for plant at Vasai, which is also the main manufacturing facility has also been successfully conducted and recommendations have been forwarded for issuance of certificate by SGS France, one of EXCIPACT’s internationally-recognized certification bodies. IDEAL CURES has yet again shown that it is very sincere about the quality of its products. This EXCiPACT™ certification is an authenticated proof that IDEAL CURES PVT. LTD. produces pharmaceutical excipients, while maintaining high quality GMP practices. IDEAL CURES PVT. LTD. specializes in excipients used in the pharmaceutical drug protection, drug release (immediate, delayed, extended or modified), taste masking, acrylic pharma polymers, neutral spheres SiO2, MCC and sugar, extended release cooling booster etc.
IDEAL CURES has received EXCiPACT™ certification for 2 of its 3 manufacturing sites. “IDEAL CURES has always given foremost priority to Quality and the grant of this certification is another jewel added to our crown”, said Mr. Suresh Pareek, the Managing Director of the company. He further added that, “The idea behind seeking this certification was to develop trust and confidence of those of our customers who are not able to audit our manufacturing facilities themselves”.
Since this certification is international in nature, in the long run it will be a boon to the excipient manufacturers and suppliers. IDEAL CURES surely hopes to gain added trust of customers with the addition of EXCiPACT™ certification in its basket of achievements.
Apart from active drug, a pharmaceutical tablet also contains other ingredients called excipients. Excipients, generally are non-active components of medicines. They do not have any therapeutic activity of their own and help formulate active pharmaceutical ingredients into finished drug dosage forms. They account for almost 90% of the total bulk of the pharmaceutical tablet. Different type of excipients like fillers, polymers, neutral spheres, taste masking agents, bulking agents, lubricants, plasticizers, glidant, pigments etc. are used for all drug forms. Excipients can influence the potency and bioavailability and release pattern of an active ingredient.
Checking the safety and quality of the API according to the standards is important, however it is also equally important to check the quality of the excipients that are used in drug formulations. Earlier there were no GMP (Good Manufacturing Practices) and GDP (Good Distribution Practices) standards to evaluate the quality of the excipients. Pharmaceutical API manufacturers had to personally carry out audits at each of their excipient manufacturers and suppliers. To reduce the amount of time and money that was being put into each of these audits a voluntary, high quality, international third party certification scheme called the EXCiPACT™ was introduced in 2012.
The EXCiPACT™ project, which began in 2008, was resourced by a consortium of expert industrialists from 5 trade associations namely, European Fine Chemicals Group (EFCG), European Association of Chemical Distributors (FECC), IPEC–Americas, IPEC Europe and the Pharmaceutical Quality group (UK). The EXCiPACT™ Certification Scheme was launched in 2012 to provide independent third party certification to manufacturers, suppliers and distributors of pharmaceutical excipients worldwide. The declaration that a product is USP/NF compliant suggests that it is made in accordance with USP . This informational chapter is effectively identical to IPEC-PQG GMP Guide 2006. EXCiPACT™ uses the IPEC guidelines to define GMP and GDP in its standards. The GMP guidelines formulated by the IPEC were in consultation with US FDA and European regulatory authorities. Thus certified manufacturers who comply with EXCiPACT™ standards in turn also comply with USP guidelines. Moreover, all EXCiPACT™ approved certifying bodies and their auditors have to undergo a rigorous assessment process in order to become EXCiPACT™ Registered and to provide certification.
Press Release by Ms. Saryu Pareek, Sr. VP- Corporate, Ideal Cures Pvt. Ltd., Mumbai, India
For further information please contact:
Web – http://www.idealcures.co.in
India HO and R&D Centre
A-223 to 229, Virwani Industrial estate
Off western express highway
Goregaon (east), Mumbai - 4000063 India.
About IDEAL CURES:
IDEAL CURES is an Indian company with international presence in more than 40 countries having its subsidiary company IDEAL CURES Europe SRL, Europe and has three cGMP manufacturing plants. Ideal Cures, is an ISO 9001:2008, WHO GMP certified company and maintains US type IV Drug Master files for all its products. Ideal Cures has 10 granted Indian Patents and 10 pending applications. Ideal Cures has spent a decade in its relentless pursuit of excellence in finding customized excipients and coating solutions for solid dosage forms, from ready to use Film Coating Systems of INSTACOAT™, INSTANUTE™, INSTASPRAY™and INSTAMASK™brand, Modified release Technologies- INSTAMODEL™ blend, NDDS and Acrylic Pharma Polymers of ECOPOL® L30 D55, ECOPOL® L100 and ECOPOL® S100 to, Ecocool Extended Cooling Boosters - ECOCOOL™ and Neutral Spheres- ESPHERES™.