Tihomir Kamenov, a Bulgarian lawyer specializing in international law, and Toni Vekov, biotechnology engineer, currently Associate Professor of Health Management, founded Tchaikapharma High Quality Medicines Inc.
The project for the development of the first plant in Varna was awarded to Architectural Bureau Helvetia. Krasimir Videlov, an expert in pharmaceutical technologies, was assigned as the first Director of Manufacturing.
Tchaikapharma’s development has been keenly followed by the public in Bulgaria and Europe. Our advantages are our large investments, innovative projects, informed selection of new pharmaceutical products and talented management team.
The company completed the construction of the first plant and after a GMP inspection by the Bulgarian Drug Agency, obtained a manufacturing license. The company was already set on the path described by the Minister of Health Dr. Ilko Semerdzhiev in his speech at the opening of the first plant in Varna: “He who would have the fruit of recognition must climb the tree of quality.”
The event was attended by representatives of the Bulgarian political, academic, public and economic elite, and by a number of foreign guests.
The state-of-the-art plant equipment was supplied by Robert Bosch GmbH. The design and implementation of the clean areas was awarded to the British engineering company, MRC Systems Ltd. Two such areas exist in the company plants: for blister packaging – area with clean class D in accordance with Directive 91/359/ЕЕС, and an area for labeling of cephalosporin vials and ampoules – a “closed” area. The pure areas implemented by MRC Systems Ltd. include the special system MRC 1500 for wall covering; doors with magnet locking; vinyl roll for the floor; Armstrong clip-in-system for the ceiling; system of air barriers.
The line for primary and secondary packaging has a capacity of 5 million tablets and capsules per annum and the labeling machine for sterile ampoules and vials has a capacity of 1.5 million per annum.
The facility successfully passed its first GMP inspection by F. Hoffmann-La Roche, and then started to manufacture Rocephin 1 g.
Manufacturing of the first registered Tchaikapharma-owned products: Bromazepam-Tchaikapharma (bromazepam), Ranitidin-Tchaikapharma* (ranitidin), Verapamil-Tchaikapharma 40 mg (verapamil) and Nifedipin-Tchaikapharma* (Nifedipin).
*Ranitidin-Tchaikapharma and Nifedipin-Tchaikapharma were the first products in Bulgaria manufactured under the so called Formpack technology of Lawson Mardon Packing. What is interesting about it is that the blister is made completely of aluminum foil, unlike the traditional AI/PVC blisters, for maximum protection of the drug against the impact of external factors (humidity, light), which is extremely important for ranitidin and nifedipin: moisture and light sensitive substances. In this way the preservation of the drug in its entire shelf life and its full therapeutic effect are ensured.
Enalapril-Tchaikapharma (enalapril maleate) was registered and reimbursed. It has been one of the most successful products for treatment of hypertension and soon took over the demand for АСЕ-inhibitors.
More products for inpatient and outpatient treatment were released. The Tchaikapharma brand became synonymous with quality and affordability in the eyes of doctors and patients.
Atenolol-Tchaikapharma (atenolol), Ceftriaxon-Tchaikapharma (ceftriaxon), Diclofenac-Tchaikapharma (diclofenac), Spironolacton-Tchaikapharma (spironolacton).
Expansion of manufacturing facilities
A second labeling installation for vials was put in operation after a contract with F. Hoffmann-La Roche was executed for the manufacturing of Madopar tablets 250 mg (levodopa/carbidopa).
New basic laboratory equipment for quality control of the batches was utilized.
The company market expansion continued with Allersan (cetirizine dihydrochloride), Jamax (selegiline hydrochloride), Korincare (nifedipine), Pentoxifyllin-Tchaikapharma (pentoxifyllin.) A sector portfolio was developed spanning six major therapeutic areas – central nervous system; cardiovascular system; respiratory system, muscle and skeletal system, bacterial infections, metabolic disorders.
Increased manufacturing necessitates creation of new plant
Manufacturing reached a volume of 4.7 million packages per year and the maximum work capacity of the Varna plant was exhausted. There was an actual risk of slowing the growth process and this marked the beginning of the second important stage in the development of the manufacturing company – the construction of a new, bigger plant in the city of Plovdiv. This was followed by the installation of three blistering lines of the Italian machine engineering company IMA and a high capacity blistering line of the German company Uhlmann.
Opening of a second plant
Tchaikapharma’s second plant was opened on March 17th, 2005, fully equipped with state-of-the art laboratory machinery for physical and chemical control and microbiology. The total value of the plant was BGN 15 million (EUR 7.7 mln.)
The opening ceremony brought many prominent government officials, with the Bulgarian President Georgi Parvanov as a guest of honor, as well as representatives of multinational pharmaceutical corporations who showed interest in contracting part of their manufacture to the company.
*The company product portfolio continued to expand with Akinestat (biperiden hydrochloride), Diltiazem-Tchaikapharma (diltiazem), Doxazosin-Tchaikapharma (doxazosin), Verapamil-Tchaikapharma 80 mg (verapamil), Verapamil-Tchaikapharma 240 mg (verapamil).
*F. Hoffmann-La Roche contracted manufacture of a third product – Madopar HBS 125 mg capsules.
Expansion of manufacturing area
Due to the company’s fast market entry, the third expansion of the manufacturing area started in late 2005 with additional 663 square meters. Fifth and sixth Uhlmann blistering lines were added.
Company registration in Macedonia
After a successful GMP inspection by the Macedonian Drug Agency of the recently inaugurated plant, the registration of Tchaikapharma medicines started in the Republic of Macedonia.
Funding of veteran monument
To celebrate the 120th anniversary of the victory in the battle near Slivnitsa of the Bulgarian army in the Serbian-Bulgarian war in 1885, Tchaikapharma High Quality Medicines Inc. erected a monument of Bulgarian officers, sergeants and soldiers fallen in the war. Tchaikapharma funded the entire project and organized an inauguration on Nov. 7. The monument was inaugurated in the presence of the Vice President of the Republic of Bulgaria, war veterans, representatives of military organizations and numerous citizens.
Successful GMP inspections followed by manufacturing contracts
Successful GMP inspections of the Plovdiv plant were performed by Roche, sanofi~aventis, Pfizer and AstraZeneca.
The inspections confirmed the compliance of the plants with all European requirements and led to the awarding of the manufacturing of Dilatrend 6.25 mg, Dilatrend 12.5 mg, Dilatrend 25 mg (carvedilol) and Endotelon 150 mg (procyanidolic oligomers).
The new additions to the product list were: AllGone (nimesulide), Antidepressa (citalopram), Cefotaxim-Tchaikapharma (cefotaxim), Co-Enalapril-Tchaikapharma (enalapril maleate/hydrochlorothiazide), Diab (gliclazide), Gliper (glimepiride), Klacar (clarithromycin), Korincare Neo (nifedipine), Lamotren (lamotrigine), Nordipin (amlodipine), Sertran (sertralin), Simvacor (simvastatin), Ticlopid (ticlopidine hydrochloride), Tonypiryn (paracetamol/ascorbic acid/chlorphenamine), Tonialgin (metamizole sodium).
Tchaikapharma was assigned the marketing authorizations for good market share medicines manufactured by Elly Lilly (Vancocin CP (vancomycin) and Axid (nizatidine).
Inspection by Torrex Chiesi leads to manufacturing of Pamitor
Torrex Chiesi performed a GMP inspection which re-affirmed our compliance with the highest standards, opening the door to the manufacture of Pamitor (disodium pamidronate.)
Headquarters moved to Sofia
In search of a more efficient market and regulatory process management system, the company headquarters was moved from Varna to Sofia.
HypoDehydra (hydrochlorothiazide), Losartan-Tchaikapharma (losartan), Metformin-Tchaikapharma (metformin), Nebivolol-Tchaikapharma (nebivolol) – now Bravylol, Pisizif SR (indapamide), Resperon (risperidone), Ropinirole-Tchaikapharma (ropinirole).
Inspection by sanofi~aventis leads to manufacturing of Endotelon
The GMP inspection by sanofi~aventis held jointly with a representative of Veritas set the beginning of the in-licensed manufacturing of Endotelon.
Tchaikapharma registered the first cancer pharmaceuticals in the company catalog – Bicalodex (bicalutamide) and Irinto (irinotecan hydrochloride trihydrate). The product list was expanded to include Ambrin (ambroxol hydrochloride), Furoser (furosemide), Ketoprofen-Tchaikapharma (ketoprofen), Lisinopril-Tchaikapharma (lisinopril) – now Cordacare. The company received consistent positive feedback from patients and doctors for the high quality, affordability and timely provision of new pharmaceuticals.
CentroQueen (quetiapine), a schizophrenia treatment drug, was released on the market. The following products were registered: Depoxat (paroxetine), Felodipine-Tchaikapharma (felodipine), Letrofemin (letrozole).
New laboratory equipment was installed and laboratory information system LIMS SM 9,2, was implemented to cover the overall work in the plant laboratories.
Expansion of manufacturing sites
Another expansion of manufacturing sites too place in the form of a 1,026 square meters shop for tablets and capsules, equipped with machines for granulation, dry-mixing, tableting and coating.
Tchaikapharma surpasses new EU standards
On Feb. 1, the Bulgarian Drug Agency issued a GMP Certificate for compliance with the EU requirements, in accordance with the Law on Medicinal Products in Human Medicine as amended. By that time the agency had been making annual inspections for compliance with the national manufacturing requirements. Still the standards we work with surpass the requirements of local legislation and adhere to much higher in-house criteria.
New marketing contracts
In 2010, Tchaikapharma High Quality Medicines, Inc. was granted marketing authorizations for 15 medicines:Alonet (amisulpride), Betablockade (metoprolol succinate), Cefuroxime-Tchaikapharma (cefuroxime), Kefadim (ceftazidime), Lifurox (cefuroxime), Bisor (bisoprolol fumarate), Cardifriend (ramipril), Climox (amoxicillin / clavulanic acid), Fosanat (alendronate), PlaquEx (clopidogrel), Pravastatin-Tchaikapharma( pravastatin), ParaCeta (paracetamol), Tobanex (topiramate), Venlafectin (venlafaxin) and Ibufen (ibuprofen).
Expansive product portfolio
In 2010 Tchaikapharma High Quality Medicines, Inc. has 69 registered medicines, covering all major therapeutic areas: cardiovascular system, central nervous system, digestive system, muscle and skeletal system, bacterial infections, coagulation and fibrinolysis, oncology, endocrine system, respiratory system, urogenital system, analgetics and antipyretics. The portfolio also includes a wide range of vitamins and food additives. The two plants annually package 280 million tablets.
Tchaikapharma High Quality Medicines continues to develop as a new large-scale manufacturing project in Plovdiv is underway.
During 2011, the following medicines receive marketing authorization:
Corabace-Co (quinapril/ hydrochlorothiazide)
Klacar powder for solution for infusion (clarithromycin)
Klacar XL (clarithromycin)