- Our standing in this business for more than a decade.
- A key indicator is reinvestment in the latest equipment and technology via medium of our newly constructed plant built as per the WHO guidelines.
QUALITY BY DESIGN
- Our newly built,state of the art facilities meet the concept of quality by design . This ensures regulatory acceptance and helps in mitigating risk of accidents or cross contamination
- The facilities ensure control of men, material based on authorizations and responsibilities for controlled reworking environment.
- Preference to quality over cost
- Buying from approved vendors only
- Periodical Vendor audits
- WHO GMP
- ISO 9001:2015
- c GMP, INDIA
- Sri Lanka
- Many more in the pipe line.
GOOD DATA MANAGEMENT SYSTEM
- Complete Process flow is controlled by ERP and a system oriented document management is in place which ensures data protection,authorizations, security, authentication etc. online.
- We have fully equipped labs with International Branded HPLC’s , FTIR’s, GC, Dissolution Apparatus, UV visible etc
- Supported by State Art of Microbiology Lab.
- Qualified technical staff and periodical training for updating of skills
- Team of Pharmacist and RA working together on regulatory documentation, products approvals and bio-equivalence.
- Products manufactured are backed by CTD dossier, validated processes and testing procedures.
- Support clients with dossiers and regulatory process for creating a win-win situation.
- QP release for clients buying from EU nations.
STRONG AND ROBUST PRODUCT PORTFOLIO
- Basket of Branded and Generic Formulations
- Over 61 DCGI (Drug Controller General of India)
- Over 120+ COPP’s and 20+ CTD Dossiers
- Willingness to develop or co develop new products
- Willingness to develop or co develop novel forms of delivery system
- Dedicated Formulation Development Lab in class 100,000 conditions to develop new formulations.
- R&D lab is fully supported by an independent Analytical development lab and stability lab.
- Tablets (nos.)———-1680
- Capsules (nos.)——-375
- Liquids (nos.)———-19.5
(per shift per annum capacities, in million)
ESTABLISHED QUALITY RECORD
- Well laid down SOP’s, stringent quality tests and vigilant checking of incoming materials ensures quality products for our clients.
- Impressive Track Record, Decade long association with MNCS and India MNCS
- No conflict of interest as we donot have any API business.
- Formulation being our core business we invest continuously in up gradation of technology, to improve the quality and output of the product.
ECONOMIES OF SCALE
- As a contract manufacturer we tend to aggregate demand across clients , benefits thus received of the low cost due to high volumes are passed on to the customers.
- SEA1 rating by NSIC-CRISIL
- Focus on employee growth and benefits that create long tenures, hence ensuring uninterrupted service to clients.
ENVIRONMENT, HEALTH AND SAFETY
- Complying to all local as well as national EHS regulations and norms