JP is only Asian Company successfully inspected by EDQM for the product Isosorbide 5-Mononitrate.
JP is recognized as an approved vendor to many reputed European users.
We have a dedicated plant involved in manufacturing (APIs) -
:: ISOSORBIDE DINITRATE and
:: ISOSORBIDE 5-MONONITRATE
The processes used have been developed in-house, thus giving us an edge over others as we have mastered the expertise in manufacturing the same.
Over the last fifteen years we have been known for our consistent quality and timely supplies by internationally reputed companies - giving us very special recognition as a reputed approved supplier. This has enhanced our market share globally.
EXPANSION
- Setting up a state of art US FDA facility with capacity of 120 MT per year for product IS 5-MN.
- Expected to commence production in 2008.
- Contract manufacturing.
OUR EXISTING FACILITY
- Successfully inspected by EDQM in Dec 2006 without any critical and major remarks.
- Revised Certificate of Suitability received in May 2007.
- Pure Pyrogen free water confirming to Ph.Eur specifications for process and cleaning.
- Isolation of pure product and further processing conducted in clean zone area.
- ICH Q7 guideline are followed and implemented by maintaining all documents.
- Consistently audited without remarks by reputed European companies.
Our manufacturing site is located at Kurkumbh - chemical zone, India and our head office is at Pune, India.
SAFETY AND ENVIRONMENT
Safety and reliability are designed into our facilities and processes from their inception. Regular programs of safety audits and maintenance reviews are conducted followed by appropriate action when necessary. We value our environment and all our processes are eco-friendly thus meeting all new regulatory requirements and norms.
QUALITY CONTROL
Professional and experienced team of personnel handle Quality Control and Quality Assurance department. Thus, we always strive to achieve perfection and satisfy our valued Customers with dedication.
Working to the highest safety standards, all the machinery is compliant with cGMP Standards.
All the reactors are 316 SS quality, validated as per ICH guidelines procedure following defined IQ, OQ, PQ and DQ standards.
Clean in place systems as per designated SOP's are in place.
