Indonesia's biodiversities are the source for active pharmaceutical ingredients. PT Dexa Medica through the DLBS (Dexa Laboratories of Biomolecular Sciences) Bioactive Fraction production facilities - which have permit for Industri Ekstrak Bahan Alam (IEBA, Industry of Natural Extract), is ready for production active pharmaceutical ingredients from Indonesian natural resources.
The medicinal drugs are produced by DLBS and have been marketed by PT Dexa Medica namely; Inlacin (oral treatment for anti-diabetic), Redacid (gastric disorders, gastroprotector), Vitafem Free Me (premenstrual syndrome), and Phalecarps (breast cancer), Disolf (anti-thrombotic and thrombolytic agents) and Dismeno (endometriosis).
President Director of PT Dexa Medica, Ir. Ferry Soetikno, Msc., MBA explained that the DLBS Bioactive Fraction production facilities of PT Dexa Medica are capable of producing active herbal ingredients in the form of Bioactive Fraction.
"This is the first pharmaceutical company in Indonesia that can produce active herbal pharmaceutical ingredients in the form of Bioactive Fraction", said President Director of PT Dexa Medica to Minister of Research, Technology, and Higher Education of the Republic of Indonesia., Prof. H. Mohamad Nasir, Ph.D., Ak. in the DLBS Building PT Dexa Medica in the Jababeka II Industrial Area, Cikarang, West Java, on Thursday, January 29, 2015.
As the second largest country for natural biodiversities, Indonesia’s natural resources can be used as potential pharmaceuticals active ingredients. "Thus, it takes several requirements such as having advantages in the field of herbal medicine research," said President Director Soetikno.
The production facilities of DLBS, PT Dexa Medica, were inaugurated by the Minister of Health of the Republic of Indonesia on August 20, 2013, and has met the requirements for Industri Ekstrak Bahan Alam (IEBA, Industry of Natural Extracts) as written in the Regulation of the Minister of Health of the Republic of Indonesia No. 006 Year 2012, on Traditional Medicine's Industry and Business.
“We are very proud and highly appreciate, that on this day, Thursday, January 29, 2015, Ministry of Research, Technology, and Higher Education of the Republic of Indonesia, gave their trust to us to establish cooperation in the field of research, while increase collaboration between the government and the national private pharmaceutical industry.” President Director Soetikno replied.
The agreement between PT Dexa Medica and the Ministry of Research, Technology, and Higher Education of the Republic of Indonesia was signed by Ir. Hari Purwanto, MSc, DIC and Ir. Ferry Soetikno, MSc, MBA, while the agreement between PT Dexa Medica and the Deputy of Relevance and Productivity of the Ministry of Research, Technology, and Higher Education of the Republic of Indonesia was signed by Dr. Ir. Agus Puji Prasetyono, M.Eng and Dr. Raymond Tjandrawinata, MBA, PhD, FRSC on January, 29, 2015 in the DLBS Building PT Dexa Medica, Cikarang, witnessed by the Minister of Research, Technology, and Higher Education of the Republic of Indonesia.
Biotechnology & Natural Sources Drug Discovery
The Executive Director of DLBS, Dr. Raymond R. Tjandrawinata, MBA, PhD, FRSC explained that DLBS has been committed to discover the new drug with a number of advantages, namely:
1. Using Indonesian Biodiversity.
2. Using the modern pharmacological principles with a biomolecular approach to discover new drugs.
3. Conducting clinical trials to complete medical evidence, according to Good Clinical Practice (GCP) and ethically conducting animal testing according to the International Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) certification which has been received by DLBS.
4. Loaded with Intellectual Property Rights.
5. Produce herbal medicine raw materials according to Good Traditional Medicine Manufacturing Practices-Industry of Natural Extract and other international requirements, such as ISO22000 and Hazard Analysis and Critical Control Points (HACCP).
"These natural medicine ingredients produced by DLBS are the results of our own research coming from Indonesian biodiversities. It started with biomolecular research, animal pharmacology test, and then clinical trials on patients in cities throughout Indonesia," said Dr. Tjandrawinata.
DLBS Production facilities have been through a validated process in a production system supported by modern technology, certified with a grade A by Halal Assurance System LPPOM-MUI, AAALAC International, ISO 22000 certification (Food Security System Management) and HACCP. DLBS finished product facility is made in PT Dexa Medica production facility which was certified with Good Manufacturing Practices (GMP), Good Traditional Medicine Manufacturing Practices, ISO 9001:2008, and ISO 14001:2004.
Dr. Tjandrawinata added that DLBS researchers study the candidates for the active ingredients of herbal medicine from the chemical and biological aspects at the molecular level through a process that is called Tandem Chemistry Expression Bioassay System (TCEBS). "TCEBS is a systematical filter methodology to find the most active potential candidate for products, along with bioassay system which utilizes gene expression and protein array technique," he said.
The success of DLBS-PT Dexa Medica in producing active herbal medicinal extracts also supports the government program in terms of autonomy national pharmaceutical active ingredients supplies. In addition, this moment also gave a value-added point for Indonesia since these active herbal extracts produced by DLBS have been patented not only in Indonesia but also worldwide, through the Patent Cooperation Treaty scheme.
A number of DLBS featured products have been marketed, namely: Inlacin, Redacid, Dismeno, Vitafem Free Me, Phalecarps and Disolf.
Inlacin is an oral treatment for diabetic patient with type 2 diabetes. Inlacin works by reducing insulin resistance and improving the glucose intake by cells. Inlacin, which contains bioactive fraction DLBS3233 was developed from Lagerstroemia speciosa and Cinnamomum burmannii that work to improve glucose and insulin intake sensitivity. During the clinical trials, Inlacin showed an ability to control blood glucose, insulin levels, lipoproteins (such as High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL)), triglyceride, and total cholesterol level.
Redacid helps to alleviate gastric disorders by reducing gastric acid and is also used as a gastroprotector. Redacid contains bioactive fraction DLBS2411 which is fractioned from Cinnamomum burmanii. It works by inhibiting the activity of H+/K+ ATPase enzyme, an enzyme that regulates proton pump in stomach. The inhibition of this enzyme would lead to the reduction of excessive gastric secretion. Redacid is an effective option for patients with gastric disorders.
Dismeno, which contains Bioactive Fraction DLBS1442, has been developed from Phaleria macrocarpa. Its mechanism is by regulating estrogen and progesterone receptors, reducing gene inflammation regulation and preventing proliferation of endometriosis tissue, which effectively overcomes endometriosis. Dismeno can also reduce menstrual pain posed by endometriosis (secondary dysmenorrhea).
Vitafem Free Me contains Bioactive Fraction DLBS1442 indicated for Premenstrual Syndrome (PMS). PMS is characterized by physical and emotional symptoms during the phase before menstruation. Bioactive Fraction DLBS1442 can reduce pain arising before and during menstruation.
Phalecarps contains Bioactive Fraction DLBS1425 which has been developed from Phaleria macrocarpa to cure breast cancer. Phalecarps has anti-proliferative, anti-inflammatory, and anti-angiogenic functions, which makes it pharmacologically good to treat breast cancer.
Disolf contains Bioactive Protein Fraction DLBS1033 which has been developed from Lumbricus rubellus that has been used for atherosclerosis patient. Disolf has ability as anti-thrombotic and thrombolytic agents through fibrinolytic activity. Also, Disolf is able to stabilize plaque on arteries thus can prevent stroke. Corporate Communications