Changing strategy Hai Duong Pharmaceutical and Medical Supplies Joint Stock Company (HDPHARMA) was established on April 21, 1961 under the name of Hai Duong Province State Pharmaceutical Enterprise. The birth of the State Pharmaceutical Enterprise was vital for the people in the context of medicine shortage at that time. However, following the ups and downs of the times, the Company's later development journey encountered many difficulties, even many crises. In 2003, HDPHARMA was equitized. After many years of doing business in Ukraine, with the desire to contribute to his homeland, in 2014, former Soviet Union student Nguyen Trung Viet returned to his homeland. He decided to invest in HDPHARMA and directly participate in management as Chairman of the Board of Directors.

Mr. Nguyen Trung Viet, Chairman of the Board of Directors of HDPHARMA (Photo: Provided by the character).

When taking over the company, Mr. Viet realized that in Vietnam, high-value pharmaceutical products and specialty drugs are mostly imported from advanced pharmaceutical industrial countries such as Germany, Italy, Spain, the US, Japan, etc. The prices of these drugs are also very high. In his mind, a desire arose to build a pharmaceutical chain that meets the standards of advanced pharmaceutical industrial countries to produce high-quality drugs, meeting the medical needs of Vietnamese people and further exporting to demanding markets. "We determined that for a manufacturing enterprise, technology and R&D (research and development) are important. Particularly for the pharmaceutical manufacturing sector, R&D is even more important and is a key factor," Chairman Nguyen Trung Viet shared. The R&D Center was quickly invested in and fully equipped with the most modern machinery. Whatever type of machine is in the workshop, the R&D Center will basically have a mini version of that machine to serve research activities.

R&D specialist operates hammer mill at HDPHARMA EU Factory R&D Center (Photo: Character provided).

Many types of specialized machines are being used at the R&D Center, including: Hammer mills, vibrating screens, high-speed mixers, granulators and grain conditioners, fluidized bed dryers, finishing mixers, tablet presses, film coating machines, angle of repose meters, hardness meters, pH meters, dissolution testers, magnetic stirrers with heating, HPLC high-performance liquid chromatography systems, etc. “Before a pharmaceutical product is manufactured and circulated on the market, that product will be thoroughly researched at the R&D Center. The Center will prepare and test produce many times to optimize the formula as well as the production technology. The product will be monitored for stability and carefully tested in the laboratory. When the quality indicators meet the requirements, the R&D Center will write a dossier to submit to the Drug Administration (Ministry of Health). Leading pharmaceutical experts of the Drug Administration will review it many times and issue a registration number. Only then will the product be commercially produced and circulated on the market. This process can take from 5 to 7 years,” said Mr. Viet. The path to take to produce high-quality domestic drugs After carefully researching the pharmaceutical market with a group of experts, the “captain” of HDPHARMA realized that EU-GMP is the path to take to be able to produce high-quality domestic drugs and have a competitive advantage. EU-GMP (Good Manufacturing Practices – European Union) is Good Manufacturing Practice according to European standards - one of the highest evaluation standards of current factories in the world. This is a set of principles and standards developed and issued by the European Medicines Agency to control activities or problems occurring at pharmaceutical production facilities. EU-GMP standards aim to ensure the production of high-quality drugs, ensuring the health of consumers. “There are 2 reasons why HDPHARMA is determined to invest in EU-GMP standard production lines. Firstly, quality is the key factor in pharmaceutical production. With that in mind, HDPHARMA persistently pursues its mission: Producing pharmaceutical products according to the highest standards of the world pharmaceutical industry, equivalent to products produced in advanced pharmaceutical industrial countries at prices suitable for Vietnamese patients. Secondly, to be able to export drugs to demanding markets such as the European Union, the production line must achieve EU-GMP certification," Mr. Viet explained.

Two HDPHARMA pharmaceutical products are manufactured on EU-GMP production lines (Photo: Character provided).

In October 2015, HDPHARMA started to build the HDPHARMA EU factory in Cam Thuong Industrial Park, Hai Duong City. To be granted EU-GMP certification, HDPHARMA's production line must meet many strict requirements including: The production process must be clearly defined and controlled to ensure consistency and compliance with technical specifications; Personnel participating in the production process must be qualified and trained in knowledge of EU-GMP standards; The factory and equipment must be designed, built, and arranged in accordance with the production process and minimize dust, cross-contamination, and risks during the production process that may affect product quality... This is an extremely complicated process and requires high expertise. Therefore, HDPHARMA has invited leading European experts to guide and supervise throughout the entire construction and production process. Due to the impact of the Covid-19 pandemic, the time to assess HDPHARMA's EU-GMP production line was prolonged. Although completed, the production line still cannot be exploited and put into use because it has not been certified. As one of the few domestic enterprises to independently implement a pharmaceutical factory project meeting EU-GMP standards without the participation of foreign shareholders like many other enterprises, HDPHARMA encountered many difficulties. In the face of countless challenges, HDPHARMA's only advantage when implementing the EU-GMP production line is having a dedicated, hard-working team with a desire to fulfill its mission. And then, on June 24, 2022, the Bulgarian Drug Administration granted an EU-GMP certificate to the production line of tablets, film-coated tablets, hard capsules, granules, and powders that do not contain Betalactam antibiotics at the HDPHARMA EU factory.

Workers operate a brewing system that meets EU-GMP standards (Photo: Character provided).

Conquering the international market “Up to now, HDPHARMA EU Factory is the first and only pharmaceutical manufacturing facility in the North to be granted EU-GMP certification. EU-GMP standards are considered a prestigious guarantee for the quality of pharmaceuticals produced on the production line: high-quality drugs, qualified for export to the world's leading pharmaceutical markets. HDPHARMA is registering many products in the European Union to soon export to this demanding market. The operation of the EU-GMP standard production line will create a big step forward for HDPHARMA in affirming its competitive advantage in quality and products; contributing to the development of the domestic pharmaceutical industry on the world pharmaceutical map”, Chairman Nguyen Trung Viet proudly said.

HDPHARMA team works with experts on requirements for pharmaceuticals exported to the EU market (Photo: Character provided).

Currently, HDPHARMA has more than 50 pharmaceutical products exported to markets such as Cambodia, Uzbekistan, Iraq, Yemen, Laos, etc. In which, Europe, the US, Canada are the most demanding markets; while the Middle East and Southeast Asia are two potential markets. The main export products include: Ka.na.dol Extra Strength, B Calcium.Kana, Ka.na.Corvit, LOPERAMID. “The general trend of the pharmaceutical industry in Vietnam and the world is to upgrade to the highest production standards to create high-quality products. The level of competition in the Vietnamese pharmaceutical market is increasingly fierce due to the participation of large multinational enterprises. Currently, we have 2 pharmaceutical factories with many production lines with full dosage forms and diverse products, so we can meet the requirements of different customers in many different markets,” Mr. Viet assessed. These days, HDPHARMA is continuing to develop other EU-GMP standard production lines such as: Cephalosporin antibiotic injection line, Cephalosporin oral solid drug line, Non-Betalactam injection line... "EU-GMP line is the only way for HDPHARMA's products to compete with products of major pharmaceutical corporations in the world. I hope to build more EU-GMP lines to produce more pharmaceutical products that meet the highest standards of the world pharmaceutical industry, bringing the best products for public health. I hope that Vietnamese people can use the highest quality pharmaceuticals produced domestically, at reasonable prices. We expect HDPHARMA to become a leading enterprise in the Vietnamese pharmaceutical industry, and our products will conquer more and more international markets", Chairman Nguyen Trung Viet expressed.

Vietnamnet.vn

Source: https://vietnamnet.vn/khat-khao-khang-dinh-duoc-pham-viet-nam-tren-ban-do-duoc-pham-the-gioi-2284629.html