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Local Bioequivalence (BE) Studies Centres

As of 1 January 2020, NPRA had revised the way the clinical and bioanalytical facilities under the NPRA BE Centre Compliance Programme. Clinical and bioanalytical facilities are listed separately and may collaborate freely with any other listed facilities. Collaborating facilities must ensure that different phases (clinical & bioanalytical) of the BE study are conducted within the listing period.

Failure to do so may result in the BE study report to be rejected during product registration submission.

Clinical Facilities

There are 4 clinical facilities that are listed in NPRA BE Centre Compliance Programme as of 16 July 2026.

Borneo Kinetics Sdn. Bhd.

Address:

Borneo Kinetics Sdn. Bhd.
Level 6, Wad Penyelidikan CRC,
Pusat Jantung Sarawak,
94300 Kota Samarahan,
Sarawak

Validity:

  1. 18 September 2013 – 18 September 2016
  2. 18 September 2016 – 17 September 2019
  3. 18 September 2019 – 17 September 2022
  4. 7 July 2026 – 6 July 2029

Contact Information:-

Telephone

+6013-8952356 / +6010-9600385

Fax

N/A

Email

borneokinetics@gmail.com

Contact Person

Dr. Lee Toong Chow / Dina Sia

 
Clinical Research Ward, Centre for Clinical Trial, Hospital Ampang
Info Kinetics Sdn. Bhd.
Questra Clinical Research Sdn. Bhd.

Bioanalytical Facilities

There are 3 bioanalytical facilities that are listed in NPRA BE Centre Compliance Programme as of 13 February 2026.

Bioxis Sdn. Bhd.

Address:

PMT 1241, Jalan Perindustrian Bukit Minyak 8,
Taman Perindustrian Bukit Minyak,
14100 Simpang Ampat,
Pulau Pinang.

Validity:

  1. 8 September 2021 – 7 September 2024
  2. 8 September 2024 – 7 September 2025
  3. 8 September 2025 - 7 September 2030

Contact Information:-

Telephone

+604-5057358

Fax

N/A

Email

bioxis2u@gmail.com
bioxis@bioxissdnbhd.com

Contact Person

Dr. Gabriel Loh Onn Kit

 
Info Kinetics Sdn. Bhd.
Questra Clinical Research Sdn. Bhd.

 

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400

 

 

DISCLAIMER

The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

Site Last Modified

  • Last Modified: Thursday 16 July 2026, 13:39:16.

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