Best Business Idea for the Setup of API Bulk Drugs Manufacturing Unit
If you are looking to evolve yourself in an API Bulk Drug Manufacturer Unit, here is everything you need to know. The best business idea for the setup of the API Bulk Drug Manufacturing Unit includes some extra cautions and characteristics. Here, I'm listing all the required things and information that will help you in starting your new business.
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The API Bulk Drugs Manufacturing Unit Business will need Location, machinery, license, and other requirements for manufacturing and chemical reactions. Moreover, some equipment will be required for laboratory and quality control processes.
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- Name and Location:
The First thing you would need to decide is the name of your business. Next, you need a location for the factory setup. The location should be about 20-25 km away from the city. It should be in an outer area. Make sure to avail around 30 acres of an area of the factory setup.
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- License:
For The license, you will need to contact the state drug control office and submit a file for granting the manufacturing license of bulk drugs API. You need to go through the Drug and Cosmetic Act & Rules. The license that is labeled as the license for API Bulk Drug business are as follows:
● Bulk Drug Manufacturing License
● Wholesale Drug License
● Factory Act Registration
● Constitution of Firm or Company Registration
● Good and Service Tax Registration
Read our Book Here: Handbook on Active Pharmaceutical Ingredients (API), Drugs & Pharmaceutical Products
● Fire NOC
● NOC from the Pollution Board.
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There are some certain documents you would require to apply for the Manufacturing License of API:
● Introductory covering letter. It should mention the name and address of the plant as well as the Administration office.
● Application in a prescribed form and format.
● Fee receipt
● ID proof of all the authorized persons, partners, directors, and proprietors.
● Ownership related documents of location or rent or lease documents.
● List of Laboratory equipment and machinery.
● Site Mater File.
● Design and layout of the HVAC system.
● Water Analysis report.
● Detailed information about technical staff.
● Blueprint of plant and layout of location with the specification of installation of machinery and equipment.
● NOC if applicable.
● Factory Act Registration if applicable.
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- Machinery & Equipment:
Next, you will require the machinery that would help you in manufacturing the API. Following are the machines you will need:
● SS and Glass Lined reactors having a capacity of 160 to 5000 ltr.
● SS and MS Rubber Lined Centrifuges.
● Glass Assemblies
● Filters
● Multi Mill
● Sifter
● Tray Dryer
● Air Jet Mill
● Blender
● Packing area.
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Apart from the machinery in the factory, you will also require laboratory equipment. The laboratory equipment required are as follows:
● Gas-Liquid Chromatography
● Total Organic Carbon Analyzer
● TOC Analyzer
● Video Microscope
● Ultra-Pure Water Purification System
● Automatic Glassware Washing and Drying Machine
● Fourier Transform Infrared Spectrophotometer
● High-Performance Liquid Chromatography.
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- Market Conditions:
If we look at the current market conditions, the global industry of API is dominated by synthetic chemical APIs. However, the biographical Bulk Drugs are gaining the profit too because of the Biotechnology industry.
Your targeted audience will be drug suppliers. You will need to focus on the wholesale trading companies to perform the desired sales.
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- Facilities:
When you are presenting a proposal of API manufacturing business setup, you will need the following facilities:
● Technical Facility
● Pharma Facility
● Quality Control Facility
● Supply Chain Management Facility
● Engineering Services Facility
● Raw Material Storage
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Key Points:
● Pharmaceutical Manufacturing Industries need continuous power, making sure the government provides uninterrupted power supply.
● A strategic location and approach are important for the implementation of this business plan.
● As you are starting Bulk Drug Business, make sure to keep the factory hygiene and avoid the infections.
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