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FACTORY I

  • Address: K63/1 Nguyen Thi Soc St., My Hoa 2 hamlet, Xuan Thoi Dong ward, Hoc Mon District., Ho Chi Minh City
  • Total area: 9.248 sqm
  • Oral solid workshop:
    • Surface area: 1.541 sqm
  • Annual capacity:
    • Tablets: 360 million pcs/year (including uncoated tablets, coated tablets, enteric tablets, hormonal tablets)
    • Granules: 21.2 million sachets/year
  • Topical workshop:
    • Surface area: 1.281 sqm
    • Annual capacity: 1 million pieces/year

 

FACROTY II:

  • Address: 40 Tu Do Avenue, Vietnam - Singapore Industrial Park, Thuan An Dist., Binh Duong Province.
  • Total area: 34.300 sqm
  • Oral solid workshop:
    • Surface area: 2.454 sqm
    •  Annual capacity: 1900 million pcs/year including:
      • Tablets (uncoated tablets, coated tablet, enteric tablets)
      • Capsules
      • Effervescents
      • Pellets
      • Granules
  • Oral liquid workshop:
    • Surface area: 1.909 sqm
    • Annual capacity 1.125 million liters/year including:
      • Bottled syrup
      • Oral emulsion / suspension
      • Oral solution ampoules
      • Liquid form sachets

Targeting at creating high-quality products, STADA-Vietnam maintains a well-established and continuous developing quality management system in accordance with EU-GMP. In addition to multi-level scientific documentation system prepared and managed by an experienced, competent staff, STADA-VN employs technology and synchronous automation as an effective tool for quality management and risk minimization.

 

Application Software in Production Equipment

Most of the equipment in production areas are controlled by Programmable Logical Controller (PLC) to set parameters of production and ensure uniformity of each batch.
Device in the manufacturing sector are equipped with SCADA systems to ensure control, manage the database and history of the production processes.
All software used in the processes of manufacturing and testing meet the requirements of 21 CFR part 11.

 

Heating, Ventilating, Air-conditioning (HVAC) System

An HVAC system consisting of 60 air handling units (AHUs), 6 special dehumidifiers, a dust collecting system, chillers and an air ducting network are designed and installed in compliance with EU-GMP requirements, to ensure that the environnement in production and storage areas satisfy the temperature, humidity and cleanliness required by the European GMP.

 

BMS System for Controlling Production Environment

Building Management System (BMS) controls humidity, temperature and air velocity with the support of SCADA system for the control, monitoring and data acquisition complying with requirements of EU-GMP. The system assures all materials and products are processed in good condition, minimizing risk factors of cross contamination and alerted when problems arise.

 

RO-CDI Purified Water System

Advanced water treatment technologies such as RO-CDI for water purification, hot water sanitization, automated control through PLC, electro polishing, pipe fitting and orbital welding are customized in the water system in order to generate purified water in compliance with the criteria stated in European and US pharmacopoeia. 

 

“Calibration Schedule Manager”

Management software is utilized to alert of maintenance schedule for production equipment, to test and calibrate equipment and sensors, and notify of necessary repairs. The software has been reviewed and assessed under the provisions of 21 CFR part 11 of the GMP - United States.

 

QUALITY CONTROL

STADA-VN’s quality control department was established in accordance with GLP requirements with experienced qualified analysts, state-of-the-art instruments and validated testing procedures in order to facilitate quality control and stability of commercial products in accordance with ICH rules. 

Data archive and acquisition are checked and updated on a regular basis on system equipment, which are connected to a server and management software application that has been evaluated under 21 CFR part 11, matching the European GMP, WHO and FDA standards to ensure accuracy, safety and the ability to recover data in case of incidents.

Standard and Working Principles

Committed to the objective of developing products for regulated markets, STADA-VN establishes its research and development in compliance with ISO 9001:2008 and implements its activities in accordance with ICHQ8 guidelines.

 

Investment for a Better Future

Every year, STADA-VN financially invests significantly in research and product development, primarily in the areas of modernization of equipment and technology, and training researchers. Production development involves testing bioequivalence and evaluating suppliers of raw materials. To keep up with the latest technology, STADA-VN actively searches for and exchanges technology with various partners as part of the CRO to improve and research pharmaceutical development. In order to fulfill the mission and commitment to supply quality products to patients, STADA-VN constantly invests in research and training of the staff with technological and professional knowledge by experienced experts from Germany and India.

 

People – the Decisive Factor

STADA-VN is proud of its team of young, qualified, dedicated and creative scientists. Pharmacists, chemists and other staff working in R&D are willing to devote to research activities and cooperate with other divisions in establishment of a strong and stable business.

 

Technology and Innovation – the Key to Success

State-of-the-art facilities and equipment similar to those of production areas facilitate research and development activities as well as technology transfer processes. In addition, our laboratories are well equipped with high performance analysis instruments such as our liquid chromatography with auto sampler, differential scanning calorimetry, particle size analyzer, etc. These high performance instruments are utilized for research, analysis and quality control.

Many approaches to novel knowledge, inventions and technologies are available for staff’s mastering and application in their work to create high-quality products.

 

Achievements

STADA-VN has successfully launched 200 of 300 developed products of various therapy groups to the market.

 

Since 2006 STADA-VN has already completed bioequivalent studies of 11 products. In the future, STADA-VN is aiming at carrying out bioequivalent studies of other products to assure that effective and safe medicines are being offered to its valued customers.

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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