One of the most important responsibilities of any pharmaceutical company is that of how to start a pharmaceutical business. It requires enormous financial resources as well as huge organizational skills. There are several steps which you need to follow if you want to know how to start a pharmaceutical company. These steps may vary from one pharmaceutical company to another and thus you need to be very careful in choosing the right pharmaceutical company for your requirements. It is always better to consult the State Health Department or FDA before you decide on how to start a pharmaceutical company.
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Initial Investment required: There is no capital required in this business, but it is definitely an investment. In order to start your own pharmaceutical company, you need at least 100k in investment. Besides investment, you will require licenses for manufacture and distribution of generic medicines. You may also require financial backup from bank and other financial institutions, depending on the requirements of your state.
Licenses to run Pharmaceutical Unit: Before you set-up your pharmaceutical company, you need to get all the licenses which are required for manufacture and commercialization of various medicines. The licenses are easily available and can be obtained from FDA, except for New Drug Application (NDA). In case of NDA, FDA has to approve the commercial production of the medicine within certain time. The final cost of investment required to set-up your pharmaceutical company depends on the licenses and the number of employees.
How To Start A Pharmaceutical Company
Initial Investment required: In case you are starting from scratch, you do not have to make any initial investment, but all your profits will go into purchasing of medicines. So, initial investment is something that you should take care off. But if you are starting a branded company in the pharmaceutical sector, there will be initial investment involved as well. This will be of many dollars, so you need to have a ready cash reserve in order to run the business successfully. The other point is that even if you are starting from a zero, you still have to make profit, otherwise your company will not last for long.
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Private Limited Company: To set-up a pharmaceutical company, you need to get a Private Limited Company, or PLC, under the name of your company. This is done by the regulatory authority of your country, or by the delegated authorities of the country. The delegated authority will also provide you with the Memorandum and Articles of Association for your company. You need to keep all these documents in a file.
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Loan license: For the purpose of manufacturing and marketing of medicines, it is required for you to get a loan license from the local unitary authority (OUI). The loan license is obtained by producing tangible goods for commercialization of the drugs and for paying the cost of production. This loan license helps you to fund the commercialization of the products of your company. This loan is usually given by the local stock exchange or by the pharmaceutical manufacturing company.
Pharmaceutical manufacturing licenses: There are two general categories of pharmaceutical manufacturing licenses. These are primary licenses and secondary licenses. The primary licenses are given to start a limited company, while the secondary licenses are for the purpose of manufacturing medicines for commercialization. The first category includes the process of formulation, development, processing and packaging of the products manufactured by your pharmaceutical company. The second category includes the design and development of pharmaceutical packaging material such as syrups, capsules and caps.
Service tax: Some of the services that are not exempted from the state sales tax include retail sales of cosmetics and toiletries, cosmetic products and perfumes, vitamin supplements and drugs, and some medical supplies. In addition to these services, the state sales tax also includes occupational licenses such as dentist and physician assistant, engineer or mechanic, and other health care service occupations that are not considered retail sales. If you have an established business in New York and want to know how to start a pharmaceutical company, you need to consider this issue so that the tax problems can be solved soon.
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