What are Pharmaceutical Raw Materials?
Pharmaceutical Raw Materials are substances, chemicals, and compositions used to curate and manufacture pharmaceutical products.
These raw materials are generally classified into three categories, ie.
- Active pharmaceutical ingredients aka API raw material
API is the main ingredient in pharmaceutical drugs and is majorly responsible for drug action. Certain standards have to be followed to decide the percentage of an API in a pharmaceutical product. These require specific maintenance and packaging as they are active ingredients in them. Active pharma ingredients need specific packaging to keep them intact.
This raw material is used to cause a reaction in API manufacturing to form the chemical and molecular specifications required to manufacture the pharmaceutical product.
Additives are the substance added to the formulation to add to the specific requirement for that pharmaceutical product. These can be used in bulk to add specific qualities to a drug formulation.
Chemical suppliers and biologics manufacturers majorly supply these raw materials to pharmaceutical companies.
Checklist to Test Quality of Pharmaceutical raw material
The quality of pharmaceutical raw materials is of utmost importance to curate a product that does the job right. Any kind of defect in the quality can be harmful to the product user.
Consistent quality is required to manufacture a product to maintain the standard attributes of the products. Quality is also important because it is a risky area; if you get your manufacturing wrong, it can cause a huge loss to the business.
The checklist to test the quality of pharmaceutical raw materials includes:
- Set Specifications for raw material
The first step is to set acceptable specifications for the raw material to have something to test against. Make the specifications clear to the supplier to maintain the quality accordingly. For example, suppose the quality test is for Vitamin B12. In that case, it has to be tested as per pharmacopeias and any other test (if required) for the quality control of raw materials.
- Trusted Suppliers
Goes without saying that it is a wise call to only buy the raw material from trusted suppliers who ensure quality material and won’t compromise with the quality in any manner. Trust is also built over time, but it is inevitable to get tricked at times if you are new in the market. So one needs to be precisely careful while selecting a supplier to meet your quality needs. Please do not refrain from thorough research and background check to ensure you deal with a trusted supplier who delivers what they promise.
Indulge in regular inspections to avoid any degraded quality of raw material. Inspect the supplier’s manufacturing system and the delivered raw material for a successful inspection. Provide a specified list of the standards required and expected from them so that there is no confusion while delivering the raw material.
- Packaging of API Raw Material
Especially while dealing with active pharma ingredients, check the packaging. Some APIs need special packaging to keep them secure and in the right state. For example, some elements need specific temperature maintenance to keep them intact and usable form.
- Conducting Lab Test
A lab test can be conducted to check the quality of the raw material. Especially in the case of manufacturing medicine and related products, it is important to keep the specified quality maintained to deliver quality products that match company standards. Lab testing of the raw material is part of the procedure as no mistakes are to be made while manufacturing pharmaceuticals. Precision is the major key when it comes to pharmaceutical products.
Where to buy the best Pharmaceutical Raw Materials?
As per stats, 70% of the bulk drugs and raw materials worth 2.4 billion are imported from China. There are multiple suppliers in India as well as the market for Pharmaceutical Raw materials is huge, which can make determining the right option a little difficult. There is an abundance of suppliers in India, but certain raw materials are not available in India; hence, they are imported from different countries.
Follow these steps to determine where to buy the best pharmaceutical raw materials.
- Decide what you want.
Make a list of the raw materials you will need for your pharmaceuticals business. First, it is important to know your requirements and specifications of the number of raw materials, quality, quantity, pricing, etc. the raw material you require depends on the scale of your manufacturing unit, demand in the market, supply available on call, availability of supplier and raw material, etc. The first step is to set a course of action to avoid hindrances while working, as time and money are crucial to the business.
- Market Research
After you have a list of your requirements, perform market research on the available suppliers in the market. Make a list of the suppliers that fit your budget and tick all your requirement boxes. Also, it is wise to perform background research as to what the supplier delivers against what they promise.
- Competition Check
It is also important to determine the competitors operating at the same level as you. Check out their suppliers, and they buy the raw materials at what cost. All the research will help negotiate a better price and not fall for unfair prices.
An in-depth market study is very important for every business, and a manufacturer needs a constant supply of raw materials to keep the manufacturing process constantly flowing. Quality maintenance can be challenging but is of utmost importance for a successful business. Another thing to highlight is the precision required in manufacturing pharmaceutical products. It can be very risky to go wrong in manufacturing such products as these need certain certifications and license clearance.
So well-performed research is the key to buying the best raw materials for pharmaceutical manufacturing.
We at Bulat Pharma deliver quality products that clear all the required lab tests and standard specifications. For more details on the utilities we provide and our products, visit our website. You can reach out to our executives for any concerns or queries about our services and products.