A pharmaceutical company
engages in activities such as the development, marketing, research and distributing of drugs in different forms and dosages. In Malaysia, the industry includes both manufacturers of generic drugs as well as those involved with producing new medicinal drugs or herbal medicines.
Investors who open a pharmaceutical company in Labuan need to observe the current market regulations as well as the intellectual protection regime that applies to local and foreign investors involved in researching new drugs and patenting formulations.
When starting this type of business it is understandable that there will be stricter regulations than for other types of companies. This is why working with our team of agents who specialize in Labuan company formation
can be helpful for many investors who are just entering the pharmaceutical industry and are not familiar with the approvals and permits needed in the field.
In this article, we describe the main conditions for opening this type of business in Labuan, we outline the general approvals and regulations as well as describe the steps for company formation in Labuan.
Starting a business in Malaysia
Labuan is a location that offers a number of advantages to those that set up a company here. Not only is the legal entity subject to low taxes, but also to a simplified incorporation process with low requirements.
The steps needed to open a company in Labuan are the following:
Choosing a type of company: in Labuan, the International Business Company will be the preferred business form, however, there are several other types of companies.
Reserving a company name: this is mandatory for new legal entities and one of our agents can help you perform a name check.
Prepare the documents and register: the company’s incorporation documents along with information about the shareholders are required; once the file is complete, the company can be registered.
Obtain needed visas: one of our agents can help the company founders obtain a Labuan business visa, as needed.
Post-registration steps: we can also assist investors in opening a bank account and handling the post-registration steps such as obtaining permits and licenses.
These are the general steps for company formation in Labuan
. According to the regulations applicable in Malaysia, that can also extend to a business operating in this field in Labuan, the company will need to obtain approvals from the Ministry of Health
, the National Pharmaceutical Control Bureau and those regarding Good Manufacturing Practice. Additional approvals will be required from the Department of Occupational Safety and Health, the Fire and Rescue Department and the Department of Environment for those pharmaceutical companies that set up production and research centers in the region.
The pharmaceutical sector in Malaysia and Labuan
Labuan is a Federal Territory of Malaysia containing the Islands with the same name and other smaller ones. For the purpose of discussing the status in the pharmaceutical sector, we will refer to the one in Malaysia as a whole.
The healthcare sector is well developed in Malaysia and its development is a priority for the Government. This is why the pharmaceutical industry is one of the ones that is being encouraged by the Government. The types of pharmaceutical products manufactured in the country can be included in four categories:
- Prescription medicine: they require a medical prescription to be distributed, usually contain higher strength active substances.
- Over the counter medication: obtained without a prescription, used in most cases for mild conditions such as headaches, minor muscle or joint problems, mild aches.
- Traditional medicines: alternative medicine such as plant-based medicines, homeopathic remedies and medicine, and other formulations.
- Health and food supplements: different formulations containing vitamins and minerals in different forms and dosages.
Large pharmaceutical companies in Labuan will focus on mainstream or generic drugs, including painkillers, antibiotics, injectable formulations or health supplements. Branded drugs owned by foreign multinational corporations in the industry are distributed by locally incorporated companies in Malaysia or Labuan which are licensed importers.
Companies in the pharmaceutical sector will produce drugs in multiple dosages, among which we can mention pills, tablets, capsules, gel capsules, liquid drugs, injections, eye preparations, and slow release or time release medications.
One of our agents who specialize in Labuan offshore company formation
can help you with additional information about the specific requirements applicable in this field.
for more details on how to open a company in Labuan, either in the pharmaceutical industry or in other business fields.