Pharmaceutical Department
1. Overview
Since establishment in 1980 as a trading company specialized in chemicals, we, TOSCO Co., Ltd., have been supplying Japanese customers with high quality chemicals manufactured in Europe, North America and mainly China.
Based on the company growth, we established Tosco Pharmachem Pvt Ltd as a subsidiary in India and merged an excellent chemical company of GM Fine Chemicals that had the manufacturing facilities in Hyderabad and Visakhapatnam.
GM Fine Chemicals supplies a variety of APIs and intermediates to the pharmaceutical companies in Europe, USA and Japan. Additionally, they have “Accreditation certificate of foreign manufacturer” that authorizes the manufacturing of APIs for Japanese market. This merger enabled the manufacturing of APIs and intermediates at our own plant as well as the process development.
Thus, we have completed a new supplier system that functions as not only a manufacturer but also a trading company.
In Japan, more medical expenses are being expected currently owing to aging progress. Now, TOSCO Co., Ltd. aims for realization of an enriched aging society by contributing to medical care through stable supply of high-quality APIs and pharmaceuticals including generics at an affordable price.
1980 Establishment of TOSCO Co., Ltd.
Procured high-quality chemicals mainly from China and supplied as a chemical trading company.
2019 Merger of GM Fine Chemicals
Enabled the manufacturing of APIs and intermediates as well as the process development.
Completion of Manufacturer & Supplier System by Close Cooperation of Japan, India and China.
2. Similar System to Japan
Plant in India can respond to the customer’s request rapidly and flexibly under the management similar to the Japanese style.
We have already been supplying APIs and API intermediates to the Japanese pharmaceutical companies.
Plant in India (Visakhapatnam)
3. High Quality, Low Cost, Stable Supply
We achieve our mottos of “High Quality”, “Low Cost” and “Stable Supply” based on advanced technology, state-of-the-art equipment and flexible and quick response.
- High Quality products satisfying the Japanese strict standard.
- Low Cost manufacturing in India.
- Flexible and Quick Response based on manufacturing at our own plant.
<High Quality>
India is a country with the largest number of pharmaceutical colleges and universities in the world, and is engaged in the development of API industry as well as human resources.
Plant in India is working on complying with GMP according to Schedule “M” WHORTSICH and relevant guidelines for Purity, Identity, Strength, Safety, Efficiency and Quality in order to supply the required APIs to our customers.
<Low Cost>
R&D Center is attached to Plant in India and we secure excellent human resources there.
Therefore, we can supply a high-quality product at a low cost by a consistent system from process development to manufacturing in India.
<Stable Supply>
We have already been stably supplying APIs and intermediates to the Japanese pharmaceutical companies.
Since Plant in India is located in the Technocrat Industrial Estate, Balanagar, Hyderabad, Telangana, it is easily accessible by train, land and air.
High Quality
Low Cost
Stable Supply
4. Contract Manufacturing
- API & Intermediate (GMP Manufacturing)
- From Milligram to Kilogram
- Scale-up
- Multistep Synthesis
- Optimization of Manufacturing Processes
- Contract Research
- Target Compound
- Budget
- Lead Time etc.
- Study on Synthesis Method
- Procurement of Raw Materials
- Safety Test etc.
- Optimization of Processes
and Analysis Methods - Scale-up [1 – 5 kg]
- Pilot Test [10 – 200 kg] etc.
/ Mass Production
- Validation of Processes
and Analysis Methods - Optimization of Supply Chain etc.
5. Synthesis Reaction
As of December 2020, we can handle the following reactions:
Cryogenic Reaction
- n-Butyllithium Reaction
- LDA Reaction
- Grignard Reaction
- Borane/Diborane Reaction
Special Reaction
- Multistep Reaction
- Carbohydrate Synthesis
- Heterocyclic Synthesis
Coupling Reaction
- Suzuki Coupling
- Heck Coupling
- Sonogashira Coupling
- Amide Coupling (DCC/EDC)
Hazardous Reaction
- AlCl3 Reaction
- LAH Reaction
- Bromination (Br2/HBr)
- Chlorination (POCL2/PCI5/SOCI2/Cl2)
- Sodium Metal/Hydride/Azide
Organometallic Reaction & Others
- Diazotization
- Chiral Synthesis
- Alkylation
- Cyclization
- Friedel-Crafts Reaction
- Column Chromatography
- Hydrogenation/Dehydrogenation
- High Vacuum Distillation
- Sulfonation (ClSO3H, MeSO2Cl)
- Amination
- Halogenation
6. Facilities & Production Capacity
Capacity of 108 kL
- Low Temperature Reaction: Up to - 140°C with liquid N2 for 2 kL to 6 kL of volume.
- High Temperature Reaction: Up to 250 °C with oil circulation for 1kL to 4 kL of volume.
- Hydrogenation: Up to 10 kg of working pressure 1kL to 4 kL of volume.
- Cleanroom: 2 Class 100,000 cleanrooms for crystallization.
Others
- GMP Warehouse.
- QC laboratories equipped with GC, HPLC and other instruments.
7. QC & QA
Quality Control Instruments
| HPLC | SHIMADZU |
| GC | SHIMADZU |
| UV Spectrophotometer | SHIMADZU |
| Semi-Micro Balance | METTLER TOLEDO |
| Karl Fischer Titrator | Polmon |
| Conductivity Meter | Polmon |
| pH Meter | Polmon |
| MR Meter | Polmon |
| Hot Air Oven | Vision |
| Vacuum Oven | Vision |
Muffle Furnace, etc.
Quality Assurance Activities
- Documentation, Approval and Issue
- Document Review
- Standard Operating Procedures (SOP)
- Validation
- Change Management
- Internal Audit
- Audit and Compliance
- Complaint Handling
- In Process Quality Assurance (IPQA)
- Asia-Pacific Quality Register (APQR)
8. Plant Tour
We accept customer’s plant tour any time.
Please contact us if you wish a plant tour.
Equipment List
| Name | Type | Capacity | Quantity |
|---|---|---|---|
| Reactor | GLR | 0.63 - 6.30 kL | 11 |
| Reactor | SSR | 0.6 - 6 kL | 24 |
| Centrifuge | SS-316 | 48 inches | 6 |
| Centrifuge | SS-316, HALAR | 48 inches | 2 |
| Agitated Nutsche Filter Dryer (ANFD) | SS-316 | 2 kL | 2 |
| Roto Cone Vacuum Dryer (RCVD) | SS-316 | 600 L | 1 |
| Vacuum Tumble Dryer (VTD) | SS-316 | 48 trays | 1 |
| Tray Drier | SS-316 | 96 trays | 3 |
| Shfter | SS-316 | 50 - 250 kg/hr | 2 |
Utilities
| Name | Capacity (or Equipment) |
|---|---|
| Coal Fired Boiler | 2 tons |
| Coal Fired Thermic Fluid Heater | 4,000,000 kcal/hr |
| Coal Fired Thermic Fluid Heater | 2,000,000 kcal/hr |
| High Vacuum System | Steam Jet and Dry Vacuum Pumps |
| Cooling Tower | 300 and 500 tons of refrigeration (RT) |
| ＋5°C Chilling Plant | 60 RT |
| -10°C Chilling Plant | 28 RT |
| -20°C Chilling Plant | 20 RT |
| Nitrogen Plant | 99.95% 25 nm3 |
9. Certification
Plant in India acquires ISO9001:2015 Certification, GMP Certification and Accreditation certificate of foreign manufacturer (Japan).
10. Product
We supply the following APIs, intermediates and starting materials to the pharmaceutical companies in Europe and USA.
We also receive contract manufacturing of other chemicals.
Moreover, we can procure the chemicals that you demand from all over China through our Shanghai branch.
Please feel free to contact us.
API
| No. | API | CAS RN | Therapeutic Category |
|---|---|---|---|
| 1 | Azilsartan | 147403-03-0 | Angiotensin II Receptor Blocker |
| 2 | Chlorthalidone | 77-36-1 | Thiazide Diuretics |
| 3 | Flurbiprofen | 5104-49-4 | Non-Steroidal Anti-Inflammatory Drug |
| 4 | Luliconazole | 187164-19-8 | Imidazole Antifungal Drug |
| 5 | Nizatidine | 76963-41-2 | H2 Receptor Antagonist |
| 6 | Ranolazine | 142387-99-3 | Antianginal Drug |
| 7 | Ravuconazole | 182760-06-1 | Triazole Antifungal Drug |
| 8 | Sertaconazole | 99592-32-2 | Azole Antifungal Drug |
| 9 | Silodosin | 160970-54-7 | Selective α1A Blocker (Urination Disorder Improving Drug) |
Intermediate, Starting Material
| No. | Intermediate or Starting Material | CAS RN | API |
|---|---|---|---|
| 1 | 2-Chloro-5-(trifluoromethyl)benzoic acid | 657-06-7 | Anacetrapib |
| 2 | 4-(4-Aminophenoxy)-N-methyl-2-pyridinecarboxamide | 284462-37-9 | Sorafenib |
| 3 | Methyl 2-ethoxy-1-[[2'-(N-hydroxycarbamimidoyl)biphenyl-4-yl]methyl]-1H-benzimidazole-7-carboxylate | 147403-65-4 | Azilsartan |
| 4 | 1H-Tetrazole-5-carboxylate | 55408-10-1 | Pranlukast |
| 5 | N-(3-Acetyl-2-hydroxyphenyl)-4-(4-phenylbutoxy)benzamide | 136450-06-1 | Pranlukast |
| 6 | 5-Methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridine-2-carboxylic acid hydrochloride | 720720-96-7 | Edoxaban |
| 7 | 4-Chloro-2,6-diaminopyrimidine | 156-83-2 | Minoxidil |
| 8 | Methyl 2-ethoxy-3-[[4-[2-(5-oxo-2H-1,2,4-oxadiazol-3-yl)phenyl]phenyl]methyl]benzimidazole-4-carboxylate | 147403-52-9 | Azilsartan |
| 9 | DCMP: 2-n-Butyl-5-dimethylaminocarbonylmethyl-6-methyl-3-[2’-[(N-triphenylmethyl)tetrazol-5-yl]biphenyl-4-yl]methylpyrimidin-4(3H)-one |
503155-67-7 | Fimasartan |
| 10 | 4-Chloro-2-pyridinecarboxylic acid | 5470-22-4 | Golvatinib |
| 11 | 4-Chloro-N-methylpyridine-2-carboxamide | 220000-87-3 | Sorafenib |
| 12 | 1-Phenethylimidazole | 49823-14-5 | Alcaftadine |
| 13 | Rhodanine-3-acetic acid | 5718-83-2 | Epalrestat |
| 14 | 3-Bromobenzaldehyde | 3132-99-8 | Starting Material |
| 15 | (3-Carboxypropyl)triphenylphosphonium bromide | 17857-14-6 | Starting Material |
| 16 | [(1R,2S)-rel-2-[(acetyloxy)methyl]cyclobutyl]methyl acetate | 98515-98-1 | Starting Material |
| 17 | 2-Amino-2-methylpropionitrile hydrochloride | 50846-36-1 | Starting Material |
| 18 | 2-Hydroxy-2-methylpropanenitrile (= Acetone cyanohydrin) | 75-86-5 | Starting Material |
Please feel free to contact us!
TEL +81-3-5577-5548