Pharmaceutical Department

Introduction of 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
Consultation
  • Target Compound
  • Budget
  • Lead Time etc.
R&D
  • Study on Synthesis Method
  • Procurement of Raw Materials
  • Safety Test etc.
Scale-up
  • Optimization of Processes
    and Analysis Methods
  • Scale-up [1 – 5 kg]
  • Pilot Test [10 – 200 kg] etc.
Industrialization
/ 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