Reporter Hwang Jae-seon. 2022.12.27
Owns one 30-ton extraction tank and four 10-ton tanks, the largest in the country. About 50 quality personnel thoroughly test and inspect raw materials and finished products. “Due to the nature of natural products, the environmental impact is significant, and consistent quality manufacturing know-how is required.”
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Different factories are competitive in themselves.
Production capacity is a powerful strength of pharmaceutical companies. A factory with qualitative as well as quantitative capabilities is a source of competitiveness. In Korea, where finished pharmaceutical products have developed, there are quite a few production facilities with diverse capabilities. Visit a unique production facility.
① Hormonal drug rare item GL Pharma Anyang Factory
② BC World Healthcare Wonju Factory, the only independent carbapenem facility
③ Hanpoong Pharmaceutical Wanju Factory, Korea’s largest production base for herbal medicine (herbal medicine) preparations
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Is it because I grew up watching the national drama ‘Heo Jun’? When you think of herbal or herbal medicines compared to Western medicines, the image that comes to mind is that they have fewer side effects and are more effective.
The market for herbal medicines stagnated due to the division of medicine, but recently, as related research and development has become more active, it is showing a trend of shared growth with herbal medicines.
The domestic herbal medicine and herbal medicine market is worth 109.7 billion won based on IQVIA data. Top players include Kwangdong Pharmaceutical, Iksoo Pharmaceutical, Kyungbang Pharmaceutical, Hanpoong Pharmaceutical, and Jungwoo Pharmaceutical.
Among these, Hanpoong Pharmaceutical holds 121 items of over-the-counter medicines (2 herbal medicines, 13 combinations of Western and herbal medicines and herbal medicines, 106 herbal medicines) and 82 items of prescription medicines as of November this year. Annual production capacity is 190,000 kg of dry extract, 280,000 kg of granule (dry, wet), 190,000 kg of powder, 70,000 kg of pill, 96 million capsules, and 500 million tablets.
Representative products include 'Good Morning S Granule', which ranks 5th in the oral laxative market, 'Chijirae Granule', an oral hemorrhoid medicine that not only improves blood circulation but also heals wounds caused by hemorrhoids, and Jayang, which combines Donguibogam manufacturing method with cutting-edge scientific technology. The tonic ‘Hanpoong Kyung-ok-ko’, etc.
Hanpoong Pharmaceutical is also conducting a consignment business for vitamin products. GC Green Cross' 'Bemax' series (Gold tablets, Active tablets, Meta tablets, Metabi tablets, etc.), which generates annual sales of about 50 billion won, is the representative consignment item.
In addition, raw materials for GC Green Cross' new natural product Shinbaro (anti-inflammatory painkiller) and Hallym Pharmaceutical's Bronpass (acute bronchitis treatment) are also supplied.
<HIT to the End> is Korea's first herbal medicine manufacturer and is growing as a herbal medicine and multivitamin CMO company. Hanpoong Pharmaceutical's Wanju plant met with Seong Rak-seon, head of the research and development department, head of the electrical quality department, and Choi Sang-geun, head of the manufacturing department, to discuss its strengths as a company specializing in herbal medicine and herbal medicine manufacturing. I listened to the features, etc.
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for a moment ! Glossary
What is the difference between herbal medicine and herbal medicine?
According to laws and regulations related to pharmacists and oriental medicine, the definitions of herbal medicine and herbal preparations are as follows. ‘Herbal medicine’ refers to herbal medicine collected from animals, plants or minerals and mainly dried, cut or purified in its original form.
In other words, herbal medicine is a substance in its original form that has not been processed separately, and can be formulated only after going through extraction, concentration, and drying processes.
Herbal medicine products refer to medicines manufactured by mixing herbal medicines according to herbal medicine principles. In other words, if approval/reporting is made according to the prescriptions listed in the 10 types of herbal medicine books and herbal medicine preparation guidelines recognized by the Ministry of Food and Drug Safety, there is no need for a separate clinical trial.
Herbal medicines are the same as general medicines in that they only differ in raw materials and require clinical trials to receive approval/report.
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From Korea’s first herbal medicine production company to consignment manufacturing of herbal medicines and general/specialized medicines
Founded in 1973, Hanpoong Pharmaceutical is Korea’s first herbal medicine company. During his training in Japan in 1970, the founder, Dr. Pilhyung Cho, was inspired by a pharmaceutical company producing herbal medicine preparations in the form of granules and tablets, and introduced this system to Korea.
Dr. Pilhyung Cho went through a lot of trial and error while introducing the herbal medicine production process in Korea. Not only was there no one with formulation technology, there was not even any training. He spared no investment, including introducing a large extractor for the first time and purchasing testing equipment such as HPLC (high-performance liquid chromatography), which at the time cost the price of several apartments. In 1994, the first Jeonju factory received KGMP certification.
Based on 50 years of know-how in producing herbal medicine preparations, it has grown into a specialized company recognized for its production capacity and quality across herbal medicine preparations beyond herbal medicine preparations. Recently, it has also been making a mark in the field of consignment manufacturing of over-the-counter medicines.
Hanpoong Pharmaceutical owns one 30-ton extraction tank, the largest in Korea, and several 3.5-ton tanks, including four 10-ton tanks. In fact, it is rare in Korea to find a company with a 10-ton extraction tank.
Considering that raw materials and water are usually added to the extraction tank in a ratio of 1:10, the simple conclusion is that a 30-ton cold wind tank can extract 3 tons of raw materials, and another company with a 10-ton tank can only extract 500 kg.
Of course, the size of the extraction tank is not everything. Know-how is needed to maintain consistent quality.
Choi Sang-geun, head of the manufacturing division, emphasized in this regard, “With nearly 50 years of experience in extraction, concentration, and drying, Hanpoong is the best company in Korea with the best work capabilities and know-how in this field.”
Production Kepa is important, but the basis is quality... 50 years of know-how accumulated by Hanpoong
According to Seong Rak-seon, head of the development division, the most important thing in producing herbal medicine (herbal medicine) preparations begins with confirming the origin of the herbal medicine (herbal medicine) listed in the compendium.
In the case of herbal medicine (herbal medicine) preparations, ‘Regulations on reporting product approval for herbal medicine (herbal medicine) preparations, etc. Based on 'Appendix 1', if the prescriptions listed in the 10 types of herbal medicine books and herbal medicine preparation guidelines are commercialized, it is recognized as safe and effective and product approval for herbal medicine preparations can be obtained.
In addition, if the quantity of the raw drug product of the product in question is the same as the item listed in the KP (Korean Pharmacopoeia) and KHP (Korean Pharmacopoeia Herbal Medicine Specifications), quality review can be conducted by applying this standard.
If raw materials that differ from the listed standards are used, separate standards must be established and managed. In this case, separate standards are set by referring to foreign drug collections such as the Japanese Drug Collection and the German Drug Collection or compendium-listed items.
Therefore, even if it has large-scale production capacity based on extraction, concentration, and drying capabilities, it is not the correct product if medicinal ingredients different from the origin described in the compendium are used.
Seong Rak-seon, head of the division, emphasized, “The part of the plant used, whether it was used as is, whether the skin was removed, etc. all correspond to the origin,” and “From here, the basics of producing herbal medicine preparations begin.”
The nature must also be checked. At this time, it is confirmed through a standard herbal medicine called a reference material for medicinal plant. It is an international standard established by the World Health Organization Western Pacific Regional Office (WHO/WPRO) seven countries (Korea, China, Japan, Singapore, Hong Kong, Vietnam, and Australia). It meets the standard.
Once the product has been confirmed and received, the quality team begins testing and inspecting the raw materials. In addition to quantitative analysis, purity tests such as heavy metal testing such as lead, arsenic, cadmium, and mercury, and pesticide residue testing are also conducted.
Hanpoong Pharmaceutical's quality team includes GC/GC-MASS (Gas Chromatography/Gas Chromatography-Mass Spectrometry) for analysis of pesticide residues, which is quite large compared to the size of the factory, and ICP-MASS (Inductively Coupled Plasma-Mass Spectrometry) for heavy metal testing. analyzer) etc. are deployed.
Quality control of herbal and herbal medicine preparations requires a lot of manpower. Since the number of main ingredients is relatively large compared to general chemical drugs, the test items required are also proportional to this. The number of test items required means that additional time and manpower are needed.
Hanpoong Pharmaceutical's Jeonju plant employs approximately 100 production personnel, 50 quality (QC, QA) personnel, and 15 research laboratory personnel. Among these, the research staff are experts with a master's degree or higher, and about 5 of them have doctoral degrees.
Jeon Jeon-yong, head of the quality department, said, "In the case of herbal medicine raw materials or products manufactured from those raw materials, compared to Western medicinal preparations, there is a lot of analysis of trace components and various tests must be performed, so there is a lot of demand for expensive analysis equipment and testing personnel." He explained, “Also, due to the nature of natural products, they are greatly affected by the environment, so a lot of know-how and effort are needed to always manufacture medicines of consistent quality.”
Considering these special characteristics, there is a need for the government to set and apply separate standards specialized for herbal medicine (herbal medicine) preparations that are different from general chemical and bio medicines.
He said, “I hope that the government and related companies will cooperate in research and development to understand the characteristics of herbal medicine (herbal medicine) preparations that use raw materials originating from nature, and to further develop and protect the excellent herbal medicine that has protected our health for a long time.” “He emphasized.
Hanpoong Pharmaceutical's vision is 'a company specializing in herbal medicine derived from natural products'.
Division Manager Seong Rak-seon emphasized, “We plan to continue research and development so that the people of our country can conveniently purchase and take safe and effective herbal medicines.”
Source: Hit News (http://www.hitnews.co.kr)
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