Contract Manufacturing Organization & Contract Research & Manufacturing Services (CRAMS) for Pharma

April 06, 2021

When it is pharmaceutical manufacturing, regulations, compliance, and quality is the topmost priority. The quality of the end product starts with the raw material of the product. It is critical to select the right contract manufacturing partner for the product's success and ultimately for the performance and reputation of the company.

India is one of the leading countries in manufacturing pharmaceutical intermediates and bulk drugs. With pricing, there are many other considerations, according to experts.

Some key considerations:

Selecting the Best Contract Manufacturer of Bulk Drugs Intermediates

Location (Geography):

Location in contract manufacturing of the pharma industry is a crucial consideration. You can primarily select the nearest contract manufacturer, and if they are somewhat local, that's just a matter of jumping in a car or maybe a train ride to the nearest town to do it. Otherwise, you're booking flights and hotels and managing all the other incidentals, which adds to the cost.

Chemical Reaction Expertise:

Chemistry of drug intermediates are complicated. Each reaction for each product may have its characteristic to react within. Consider chlorination; chlorination with thionyl chloride is a unique chemical reaction to carry out with special expertise. At Shree Ganesh Remedies Limited, we have more than 25 years of experience in various chemical reactions. Currently, we are capable of handling wide range of chemical reactions such as Chlorination, Reduction, Bromination, Friedel-Crafts, Grignard and other miscellaneous chemical reactions at our Ankleshwar facilities.

Quality & Compliance:

Quality and compliance are two primary considerations for selecting the manufacturer. From quality control facilities to quality assurance, it should be matching your expectations and market demand. Backorder will not be a solution as it will disturb your timeline for sure. The product should be complying the norms of the market and regulatory bodies. You can check their regulatory compliance capabilities to be assured.

Capabilities:

Selecting a manufacturer who has already manufactured your product or who has tackled similar chemistry is preferable. You would not like to be their first experience to try your products. Select a capable manufacturer who has experience in your product and scaling capabilities as per your requirements.

Responsiveness & Communication:

Select a responsive manufacturer considering how quickly a CMO response can indicate future dealings. Don't forget that all their Business Development team wants is a new business, and typically, they will do whatever it takes to get it. So, responses to your inquiries to your further queries are essential factors to consider. Transparent and open communication channels are critical to the successful transfer or development of your product. Getting to know team members can give you valuable insight into how a company works and its value.

Scaling & Supply Chain:

Select the contract manufacturer who has already worked for a company as of yours. It will make your decisions much easy to select the manufacturer. Being little fish in a big pond is as risky as being large fish in a bit of a pond. If you are a small start-up, do you want to be in contention with a large-scale company with high volumes for the same manufacturing space? Also, what are the costs of your production getting bumped?

Double-check the supply chain capabilities of the manufacturer. The stronger the supply chain, the more punctual the product delivery will be.

So, the quality, responsiveness, the communication you have with your supplier, the people at the manufacturing facility, and the technical expertise that keep pharmaceutical companies with a particular CMO or CRAMS. It's interesting how most companies may focus on price initially. Still, it seems that a low price isn't as important if there are supply interruptions due to late deliveries, quality issues, account neglect or apathy. At that point, the price doesn’t seem to matter as much.