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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.
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.
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.
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.
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.
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.
Conclusion
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.
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Picking the Perfect API Partner
Contract developers and manufacturers of active pharmaceutical ingredients (APIs) are now playing an even more fundamental role in contemporary drug development strategies.
A report by analyst firm visiongain forecasts that the overallpharmaceutical contract manufacturing market is growing fast, achieving revenues of $84.0 billion by at a compound annual growth rate of 6.4% from . The market, says visiongain analysts, is expected to continue to grow from to as more pharmaceutical companies strategically outsource manufacturing services.*
With the growing reliance on contract services and a fragmented landscape creating plenty of choice, it is more critical than ever to pick the right CDMO.
Where API strategy and procurement tactics intersect
Because most product plans are unique, choosing a small molecule API and drug substance manufacturer that can provide excellent quality, while routinely demonstrating supply reliability over a drug&#;s entire lifecycle, is worth a concerted effort. Finding a &#;perfect&#; partner to marry your drug strategy can be as challenging as it is critical to market success.
Critical qualities and attributes of strategic small molecule API partners
Pharma&#;s drug developers are increasingly sourcing APIs from CDMOs. These intellectual property owners have to evaluate a number of critical aspects in making their choice for such a strategic partnership, including the overall program&#;s financial viability. More and more current drug strategies hinge on the partner&#;s technical and operational capabilities and their experience synthesising the target compound in question. Most procurement professionals understand these competing priorities despite extreme pressure from their organizations to closely control program costs.
That&#;s why when selecting a partner to develop and manufacture small molecule APIs and meet strategic business interests, the decision to choose a supplier must be weighted appropriately among all the critical, strategic attributes a &#;perfect&#; API partner should have.
Here are six critical, strategic attributes to consider right up front when choosing a small molecule API partner:
1. Reliable supply chain
Great access to a well-executed quality supply chain is an essential attribute of any strategically important supplier. How well one&#;s API supplier manages its own raw material supply chain is a leading indicator. Any disruptions to your supplier&#;s supply chain and your API delivery may be delayed. Pfizer CentreOne, being embedded within Pfizer has direct access to one of the industry&#;s most developed, secure and reliable supply chains in the industry
2. Robust, relevant process expertise and experience
Drug development routes are getting more complicated and the APIs in high therapeutic demand are getting harder to make. Robust process development is paramount, but it has to be matched to deep science and process engineering acumen. This clearly extends to troubleshooting and refining synthesis to find new or better production and cost economies, as well as creating those more robust and effective processes that increase quality and reliability.
3. Knowledgeable in how to accelerate your product&#;s pace to market
Pharma understands that the more directly and succinctly a drug developer can manage a drug&#;s critical timelines on the way to market, the more successful the product will be financially, both in the near and far term.
Early, intensive synthesis analysis is one good way potential partners can add value. Pfizer CentreOne for example, was presented recently with a synthesis that was unsafe to reproduce even under the strictest of lab conditions and controls.
Within a very intensive timeframe, Pfizer chemists and process engineers were able to define a much more stable, scale-able chemistry to reliably make the high-value therapeutics being developed by the company
4. Great quality systems, operational excellence and the staff to back it up
Achieving critical quality attributes (CQAs) with consistency and transparency is certainly a prerequisite for any strategic supply relationship. But for pharma, it&#;s a fundamental requirement and a key performance indicator when assessing the potential for long-term reliability and quality when choosing a strategic API supplier.
For APIs of every kind, one common CQA denominator is the ability of your API developer and manufacturer to effectively, cost efficiently control contaminants or impurities during all primary and intermediary processing steps.
Another KPI is controlling and manipulating an API&#;s physical properties effectively is another KPI. A CDMO partner with the staff, technology and experience to evaluate and address your API&#;s physical properties for therapeutic action and other goals is intrinsically strategic. A supplier that can accurately engineer drug substance attributes to meet drug formulation and drug product (DP) targets early in a small molecule API program can often yield efficiencies to leverage later in the journey to market.
Lastly, when combined with a robust and repeatable process, &#;small molecule&#; API becomes &#;commercial-ready&#; API with a validated process well-proven and ready to go the distance over the drug product&#;s intended life-cycle.
5. An extremely conscious approach to sustainable industrial process
Thinking environmentally? Suppliers that can provide more stable, less volatile chemistries and efficient batching are more efficient. Those with experience optimizing processing methods that reduce or recycle intermediates and other hazardous by-products, are worth considering very carefully.
CDMOs that put an emphasis on delivering cleaner chemistries that reduce their impact on the environment through best-practice operations and technical mastery are better able to deliver project economies. With literally hundreds of CDMO partners to choose from, those that live core sustainability principles of re-use, recycle and reduce, are likely to be both great environmental stewards and the most cost-efficient processors.
6. A singular focus on continuous improvement, flexibility and intelligent collaboration
Processing API batch after batch, month after month, year-after-year may, over time, introduces complacencies and issues related to status-quo in process, operations and technology. If your chosen small molecule API manufacturer is not continuously focused on continuous process improvement, they may not be the perfect partner for strategic drug supply.
CDMOs with experience and vision will likely be able to bring an intelligent, collaborative approach to partnering and the insight needed to innovate solutions. Part of this comes from the talent and resourcefulness of the people who make your API and how they leverage the resources and technologies to assure the best outcomes of every batch. These attributes support creating an environment that is responsive, agile and more capable of performing over the long run.
Whatever your product&#;s market agenda might be, drug owner and drug maker often have to build a common base of knowledge and do it in a timely and prescribed manner. Better drugs begin with a better, smarter collaboration and the sooner both parties can achieve a true and transparent meeting of the minds, the better.
A strategic API partner will always be seeking ways to innovate and improve your compound or product&#;s value as part of the deal, and do it with the dedication of a partner, not a supplier.
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