Panexcell at a Glance

History
  • Panexcell Clinical Lab Private Limited (Formerly known as Drug Monitoring Research Institute (P) Ltd.) was established in the year 1998, in Sion, Mumbai - India.
  • Spread over 800sq.m., it was equipped with just one HPLC (High Performance Liquid Chromatography) and a four member team.
  • In 2006, Panexcell shifted its facility to Rabale, Navi MumbaI - India.

 

Current Status

Currently, Panexcell is well-established with sophisticated instruments, comprehensive total quality management systems, standard processes specifically designed for high-quality deliverables, a sustained and reliable regulatory environment, and highly trained manpower.

Milestones


2017


MOH Chile Facility Approval


2017


CDSCO (DCGI) Facility Approval


2015


MOH, Turkey Study-approval.


2015


MHRA, UK Study-approval.


2015


USFDA inspection carried out at our facility in December 2015 cleared with 0 483 observation.


2015


CDSCO (DCGI) Facility Approval


2014


TGA, Australia Re-approval.


2014


HAS, Singapore Re-approval.


2014


USFDA approval for BA/BE study.

DCG(I) – Re-approval.

Name Change: From “Drug Monitoring Research Institute (P) Ltd.” To “Panexcell Clinical Lab Private Limited”.


2013


CDSCO (DCGI) Facility Approval.


2012


MOH, Kazakhstan Re-approval.


2012


MOH - Turkey Re-approval.


2011


MOH - Malaysia Re-approval.


2010


Phase IIA – Australian TGA submission: NCE (New Chemical Entity) for patients with Pediculosis Capitis conducted in-house.

Phase III – USFDA submission: Dermatology trial for patients infected with Tenia Pedis conducted in-house.

Phase I – DCGI and USFDA submission: NDDS (Novel Drug Delivery System) formulations for patients infected with breast cancer. (Conducted at 5 sites).


2009


Phase II – USFDA submission: NDDS (Novel Drug Delivery System) formulations for patients with Pediculosis Capitis conducted in-house.

UK - MHRA approval


2008


MCC – South Africa approval.

MOH – Turkey approval.


2007


Drug Controller General-India approves Panexcell facility.

Phase I (late) – USFDA submission: NCE (New Chemical Entity) for Type II diabetes patients
(Conducted in-house).


2006


Set up a State-Of-The-Art Clinical Research Facility at Rabale, Navi Mumbai - India.


1998


Drug Monitoring Research Institute (P) Ltd. was established at Sion, Mumbai - India.