Vietnam is focusing on the production of specialty pharmaceuticals.

1. Introduction to Specialty Pharmaceuticals and Production Trends in Vietnam

In recent years, the Vietnamese pharmaceutical industry has seen strong development, especially in the production of specialty pharmaceuticals. These are drugs that are exclusively invented and produced by a pharmaceutical company, have their own trade name, and are usually protected by patents.

Previously, Vietnam mainly imported specialty pharmaceuticals from abroad. However, currently, domestic pharmaceutical companies are gradually focusing on producing specialty pharmaceuticals to reduce dependence on imports, while meeting domestic demand and expanding exports. This opens up many great opportunities but also poses many challenges for pharmaceutical manufacturing businesses in Vietnam.

One of the important factors that helps the specialty pharmaceutical manufacturing industry develop sustainably is the standard-compliant cleanroom system. This is a mandatory condition to ensure the quality of pharmaceutical products before they reach consumers.

2. Why is Vietnam Focusing on Developing Specialty Pharmaceuticals?

There are many reasons why Vietnam is promoting the production of specialty pharmaceuticals:

• Strong growth of the domestic pharmaceutical market: The demand for specialty pharmaceuticals in disease treatment is increasing. People also tend to prioritize domestic drugs with equivalent quality to foreign drugs but at lower prices.
• Support policies from the state: The government has issued many preferential policies to encourage domestic drug production, reduce import taxes on raw materials, and support loan capital for pharmaceutical businesses.
• Large export potential: Vietnam has the opportunity to expand its market to Southeast Asian countries and beyond when it achieves international quality standards such as GMP-EU, FDA.
• Strong development of cleanroom systems: Specialty pharmaceutical manufacturing plants are being heavily invested in GMP-WHO, GMP-EU standard cleanroom systems, helping to better control product quality.

3. Challenges in Producing Specialty Pharmaceuticals in Vietnam

Despite many opportunities, the Vietnamese pharmaceutical industry also faces many difficulties in developing specialty pharmaceuticals:

• High investment costs: Research, development, and production of specialty pharmaceuticals require large capital investment, from building factories, purchasing equipment, researching formulas to clinical trials.
• Fierce competition from foreign pharmaceutical companies: International pharmaceutical corporations have advantages in technology, capital, and experience.
• Strict standard requirements: To produce specialty pharmaceuticals, factories need to meet standards such as GMP-WHO, GMP-EU, FDA, which require strict quality control processes.
• Shortage of high-quality human resources: The pharmaceutical industry requires a team of engineers and experts with high professional qualifications, while human resources in Vietnam are limited.

So, what solutions can help Vietnamese pharmaceutical businesses overcome these challenges? Building a standard-compliant cleanroom system is the most important key.

Opportunities and challenges of the Vietnamese pharmaceutical industry

4. Cleanroom – Key Factor in Specialty Pharmaceutical Production

Pharmaceutical production, especially specialty pharmaceuticals, requires an absolutely sterile environment. Even small dust particles or bacteria in the air can damage the quality of the drug, posing a danger to users. Therefore, a GMP-compliant cleanroom plays an extremely important role in ensuring the quality of specialty pharmaceuticals.

A standard-compliant cleanroom system in the pharmaceutical industry needs to ensure:

• Air cleanliness level (according to ISO 14644-1 standard)
• Control of temperature, humidity, air pressure
• HEPA/ULPA air filtration system to remove bacteria and fine dust
• HVAC (Heating, Ventilation, and Air Conditioning) system to maintain a stable environment
• Standard-compliant cleanroom materials to minimize the generation of dust particles and bacteriaModern cleanroom image in the future

5. The Role of Anh Khang Cleanroom in the Specialty Pharmaceutical Production Industry

As a unit specializing in cleanroom design, construction, and solution provision, Anh Khang Cleanroom is accompanying many pharmaceutical businesses in building GMP-standard specialty pharmaceutical manufacturing plants.

Anh Khang Cleanroom's Cleanroom Services

✅ Consulting, designing, and constructing GMP-WHO, GMP-EU cleanrooms for specialty pharmaceutical manufacturing plants.
✅ Installing HVAC, AHU, FFU systems, ensuring optimal cleanroom environment control.
✅ Providing cleanroom equipment such as Pass Box, Air Shower, UV disinfection lamps.
✅ Cleanroom measurement and testing, periodic maintenance, ensuring stable system operation.

Anh Khang Has Implemented Cleanroom Projects for Pharmaceutical Plants Such As:

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With many years of experience in the field of cleanrooms and M&E electromechanical, Anh Khang Cleanroom is committed to providing high-quality cleanroom solutions, helping pharmaceutical businesses optimize investment costs, meet GMP standards, and enhance competitiveness in the market.

6. Conclusion

Vietnam is making strong progress in the production of specialty pharmaceuticals, opening up great opportunities for the domestic pharmaceutical industry. However, to succeed, businesses need to invest in standard-compliant cleanroom systems, ensuring the quality of specialty pharmaceuticals according to international standards.

If you are a pharmaceutical business looking for cleanroom solutions for a specialty pharmaceutical manufacturing plant, please contact Anh Khang Cleanroom for detailed consultation!

ANH KHANG CLEANROOM MECHANICAL AND ELECTRICAL JOINT STOCK COMPANY Hotline: 1900 636 814 - 0902 051 222 Email: info@akme.com.vn Website: akme.com.vn Add: Lot B7 - Xuan Phuong Garden - Phuong Canh - Nam Tu Liem - Ha Noi.