Example 1: Cost Saving

Dr. Reddy’s CPS has been a supplier of choice for one of the pharma majors for GMP manufacture of clinical material.
This hard earned position has been a result of continued on-time delivery and exceeding expectations on chemistry and manufacturing skills for over two years and scores of projects.

As an illustration, CPS was recently awarded an API process optimization and scale-up project involving 15 stages and 3 Suzuki coupling reactions. Cost of raw materials for manufacturing 1 kg of the API was $140K.

Following the technical package provided by the customer in the laboratory on a small scale, it soon became evident to the chemistry team that the process had several yield and purity issues and would need several modifications before optimization could be attempted for scale-up.

CPS recommended a change in the process that involved a bromo-compound to a chloro-compound. A team was created at CPS and at customer’s end to recommend a new set of ligands and catalysts for the Suzuki coupling reactions. Both teams came-up with different recommendations.

CPS was given an opportunity to demonstrate feasibility which resulted in a process that could be scaled-up with a new per kilo raw material cost of $65K. Same process with customer’s recommended ligand and catalyst yielded a raw material cost of $98K.

Not only did CPS deliver a superior process that could be used for future large scale manufacturing but also saved the customer a significant sum in chemical cost. Even at a modest 5 kg scale the savings in just the raw material cost for the API translated to $375K.

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Example 2: Execution Excellence and Delivery Time

Dr. Reddy’s CPS was entrusted recently with manufacturing a key intermediate that is utilized for manufacture of a pandemic prevention medication. Facing a sever supply shortfall scenario, the innovator was looking for a capable supplier that could produce several tons in short order with limited or no prior experience with the involved chemistry.

Customer provided a tech-pack and the starting raw material. Technology Development Center (TDC) in Hyderabad did an initial feasibility study on gram basis and the process engineers were involved from the project initiation stage itself.

Armed with satisfactory results and with confidence in the process design documents, the process engineering team did the tech-transfer to commercial manufacturing site at 250kg scale in Cuernavaca, Mexico within 6 weeks of initiation of laboratory trials. First commercial production batch met all quality parameters, the fourth batch met customer’s expectation on yields and in the subsequent batches yields exceeded those reported by the big pharma.

Dr. Reddy’s CPS was not only able to mitigate customer’s risk of shortfall of a pandemic prevention medicine meeting 20MT requirement of the intermediate but also did so against daunting timelines and stringent specifications. This superior value add to the customer did not go unnoticed and the customer awarded an order for another 20MT of the intermediate.

This 20MT was the balance of the year’s requirement for which three suppliers were competing and Dr. Reddy’s CPS won the project based on the rapid manufacture of the first 20MT order exceeding customer’s expectations on yield and quality.

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Providing Flexibility in Meeting Customer Request

Example 3: Volume and Timing

Dr. Reddy’s CPS has a long term supply agreement for supply of a recently launched NDA product. The major pharma initially placed an order for launch quantities and within three months came back with revised market estimates. Their requirement of the API had tripled.

In order to meet the urgent customer need, Dr. Reddy’s invested in incremental capacity, worked with raw material suppliers to compress lead times to the extent possible and reworked production schedules to produce three times the initial order within six months.

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Example 4: Changed Specifications

Dr. Reddy’s CPS has been working with several emerging pharma companies providing clinical trial material from early to late phase of development. CPS was initially awarded a process research project to identify the sourced of an impurity.

Satisfied with the service provided, the customer decided to award CPS the optimization and scale-up job too for the eight step synthesis to produce 30kg of the API within five months. Given the short project timelines, the team focused on most critical steps and implemented learnings along the way.

When we reached stage-6 during scale-up, the customer changed an impurity specification and introduced a new specification on polymorph. The team responded by developing a new crystallization method to control the polymorph and the third step was modified to control the impurity.

Even with these changes, the team was able to manufacture the requisite quantities meeting specifications with only two weeks added to the initial timelines. Satisfied with the responsiveness of the team and technical competency, the customer has placed an order of additional 50 kg of the API and project need of another 100 kg in the immediate future.

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