Rx Manufacturing Profile

General Information

            There is any out sources of company to manufacture the products under license of R.X. Group of which the raw materials and packing materials are partially supplied by R.X. Manufacturing Co., Ltd. The out sources company shall comply to GMP standard and get the approval from FDA which renewal on regular basis. The maintaining GMP certificate from FDA is the guarantee of those out sources to assure their quality and system exclusive of controlling by R.X. Manufacturing.

            R.X. Manufacturing Co., Ltd. implements GMP to align with FDA regulation and introduce the ISO 9001 standard to develop and strengthen the people and system, satisfy customer and continue improvement. ISO 14001 standard to responsible for the environment.

            R.X. Manufacturing was granted GMP Certificate from Thai FDA since the beginning of its operation in December 2004. At present R.X. Manufacturing is granted GMP Certificate from Thai FDA from November 20, 2006 and recertified every 3 years. The scope of GMP Certificate for R.X. Manufacturing is Non-sterile products (tablet, capsule) Penicillin non-sterile products (powder, tablet, capsule) This premise has no production of Cephalosporin, Hormones and Anticancer drugs.

There is no other manufacturing activities carried out on the site.

Name and Address of Site

R.X. Manufacturing Co.,Ltd. 76 Moo 10 Salaya-Bangpasi Road, Tumbon Narapirom, Amphur Banglane  Nakornpathom 73130 Thailand.    

Telephone No. of contact person (66)063 205 7085 - 8

Type of Actual Products Manufactured

              Non-sterile products

                   Solid dosage forms

                        - Unit dose form (tablets, capsules)

                        - Multi dose form (powders)

              Penicillin product in tablet, capsule and powder. They are produced in the penicillin building

              Human products are prepared on the site only

A short description of the site

              R.X. Manufacturing is located at 76 Moo 10 Tumbon Narapirom, Amphur Banglane, Nakornpathom.

              R.X. Manufacturing occupies 10.8 acres piece of land which comprises 4 buildings which are non-penicillin building, penicillin building and utilities building.

                       - Non-penicillin building has an area of 4,653 square meters.

                       - Penicillin building has an area of 1,548 square meters.

                       - Utilities building has an area of 498 square meters.

              There is warehouse which are raw materials warehouse, finished goods warehouse and packing materials warehouse in non-penicillin building and penicillin building. Laboratory is also in the non-penicillin building and penicillin building as well.