If you glanced at medicine packages, you would find the chemicals and composition used to manufacture the drug. Pharmaceutical manufacturing does not just use chemicals as raw materials. Besides synthetic and biologics, pharmaceutical raw materials include natural materials such as leaves, flowers, fruits, fungi, and seeds.
Active pharmaceutical ingredients (APIs) and excipients are the industry’s two types of pharmaceutical raw materials. Chemical suppliers andpharmaceutical ingredients manufacturers are among the major raw materials suppliers to the pharmaceutical industry.
What is Pharmaceutical Raw Material?
The pharmaceutical raw material comprises different substrates or elements that can be used to manufacture different types of drugs, such as drugs that treat endocrine disorders, musculoskeletal disorders, and anti-infective drugs. It also includes penicillins, ampicillin, cephradine, etc. Ingredients and excipients used to manufacture pharmaceuticals come from various sources.
Chemical compounds, such as acids, alcohols, esters, phenones, and pyridines, produce pharmaceutical raw materials. Depending on the source, they may be natural or synthetic. Many active pharma ingredients previously obtained from natural sources are now being synthesized or biotechnologically produced. This is because they are more economical, safer, and quicker to manufacture artificially.
As part of the production of pharmaceutical drugs, raw materials such as active pharmaceutical ingredients (APIs), also known as bulk active ingredients, are essential. In other words, these drugs are pharmaceutically active and have the pharmacological effects they are supposed to have. For example, alvimopan, sparfloxacin, sapropterin dihydrochloride, lanreotide acetate, nicotinic acid, etc. A pharmaceutical excipient is an inert substance that aids in delivering the active ingredient, such as binders, coatings, disintegrants, and fillers.
A high-quality standard is expected of raw chemical materials used in the pharmaceutical industry. Their purity and the specific technical parameters that result from the specific production process place strict requirements on these intermediate products.
The International Organisation for Standardisation (ISO) recommends that raw pharmaceutical materials be made by manufacturers who adhere to ISO standards, such as Bulat pharmaceutical. Theactive pharmaceutical ingredient companies‘ regulatory responsibilities are defining requirements for quality management systems (ISO9001) and environmental management standards (ISO14000).
Types of Pharmaceutical Raw Materials?
ACTIVE PHARMACEUTICAL INGREDIENTS IN RAW MATERIALS (APIs)
Active pharmaceutical ingredients (APIs) and inactive ingredients or excipients are raw materials in pharmaceutical products. Active pharmaceutical ingredients (APIs) are medicines that are pharmaceutically active and produce a desired pharmacological effect, whereas excipients are substances that are pharmacologically inactive and typically used as a carrier for the API in a drug.
Among the main components of the pharmaceutical drug is the API, which performs the drug’s action pharmaceutically. When making API, accuracy and precision are two essential factors.
Standards for determining API strength in drugs: There are certain standards for determining API strength in drugs. By law, manufacturers must prove the potency of their products in labs and real life through patient tests.
Approximately $198.8 billion is expected to be generated by the Active Pharmaceutical Ingredients market by 2022, making it at the top of the pharmaceutical raw materials price list. Patent expiration, government initiatives, penetration, and the older population mainly drive this growth.
Asia, India, and China are the countries with the largest manufacturer of APIs.
EXCIPIENTS IN PHARMACEUTICAL RAW MATERIALS
A pharmaceutical excipient is a cost-effective, stable, easily handled, and inert component. Formulations contain excipients to increase bulk, facilitate absorption, provide stability, and prevent denaturation. In addition to capsules, tablets, liquids, inhalers, implants, and injections, excipients are used in various medicinal products.
An excipient is also known as a drug carrier or an inactive ingredient. Excipients are raw materials used in pharmaceuticals, such as solvents. By facilitating absorption and preventing denaturation of drugs, excipients give drug formulations bulk and stability.
Materials that qualify as excipients must follow guidelines set by international pharmaceutical standards.
Analysts report the global excipients market to reach $7.7 billion by 2022, with a compound annual growth rate of 6.53%. By ASD reports, the global market for excipients is being driven by a rise in the consumption of oral drugs.
Due to its large excipient manufacturers and rising pharmaceutical drug demand, North America holds the largest market share for pharmaceutical excipients. Following Europe, Asia Pacific has the second-largest global market share.
Problems with Pharmaceutical Raw Materials Market
Counterfeit Product Threat
The pharmaceutical supply chain worldwide is susceptible to false medicines and counterfeit drug products. It is usually the case that counterfeit drugs are made with lower-quality APIs, with incorrect ingredients, or with the wrong dosage.
Counterfeit products can cause side effects and complications due to fraudulent mislabeling and non-compliance with intellectual property rights. Taking such actions will negatively affect raw material manufacturers in the pharmaceutical industry. This is leading to the increasing popularity of medical surveillance services and fake-identification technologies such as mass spectrometry, infrared spectroscopy (FTIR), nuclear magnetic resonance spectroscopy, Raman spectroscopy, and gas chromatography-mass spectrometry (GC-MS), which are used to detect fake samples.
Trade Taxes Increase
Pharmaceutical companies manufacture their final products in primary markets such as the United States and Europe. The raw materials for these drugs are often procured from emerging countries such as Brazil, China, India, and Israel. Customs and trade taxes are additional expenses that drug manufacturers have to bear. The Trump administration has slapped a double-digit tariff on companies outsourcing drug manufacturing activities to promote the “Made in America” movement. Due to such regulations, pharmaceutical raw material manufacturers will be discouraged from obtaining cheaper raw materials.
Delays in Regulating
The government and medical associations heavily regulate drugs and medicines, which are sensitive issues regarding public health. Therefore, pharmaceutical raw material suppliers need FDA and EMA approval to market their products. Delays in the approval process can slow down time-to-market, and patent validity may expire, among other issues. A delay in production can severely impact drug manufacturers’ profit margins, thus hindering the market’s growth as a whole.
Bulat Pharmaceuticals’ mission is to manufacture raw materials that follow the highest standards as a manufacturer of pharmaceutical raw materials. The Bulat Pharmaceutical Company is widely respected for its high quality and purity of raw materials that it distributes to major pharmaceutical companies worldwide, including those in Poland.
The company produces an extensive list of raw materials for the pharmaceutical industry, and it can offer common APIs for drugs. We can offer our clients active ingredients, raw materials, excipients, and additives in one place and the ability to purchase them directly from a global manufacturer of chemicals.