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API Drug Substance Development & Manufacturing

SCL Lifesciences as a Global API Development Partner

At SCL Lifesciences, we take pride in being a trusted partner in API manufacturing. Having developed and delivered high-quality APIs, specialty chemicals, and advanced intermediates to our MNC customers for over three decades. SCL Lifesciences has built a legacy of trust and reliability, capable of supporting your requirements including that of CT stage development, high-potency molecules and niche generics.

Our end-to-end process covers:

Selection of Suitable route of Synthesis

Chemical Synthesis & Purification

QC, Packaging, & Regulatory Compliance

Strong Emphasis on Backward Integration

Our global footprint extends from USA, Europe, Japan, S. Korea, Latin America, CIS, MENA, and RoW markets, backed by global regulatory approvals and certifications such as USFDA, Japanese PMDA, Korean MFDS, ANVISA Brazil and several CEPs.

All the new product development activities are undertaken at our state-of-the-art Knowledge Centre based in the Genome Valley, Hyderabad.

Find your API using CAS

Easily locate your desired API by searching with its CAS number for precise identification.

Accelerate Your Development Journey

Our development process is designed to accelerate your journey to market, ensuring timely delivery of high-quality APIs.

  • Concurrent Development & scale up

  • CFT driven & PMO monitored development.

  • Manufacturing facilities with Regulatory approvals from International Agencies like WHO Geneva, Japanese PMDA, USFDA, EDQM, etc.

  • Documented Technology development & seamless transfer.

  • Capability to Validate Small Scale to pilot and Commerical manufacturing scale.

  • State of ART (SOTA) - R&D, instrumentation, facilities, skilled, trained & experienced scientific force to help, develop & troubleshoot at the earliest if need be.

  • Development, Technology transfer, Validation, and Impurities reports to support the customer for regulatory filings.

  • Depending on the requirements, a flexible development, validation & manufacturing plan can be designed to suit the customer.

The Custom API Synthesis

Custom Active Pharmaceutical Ingredient (API) synthesis is a specialized process tailored to develop and manufacture APIs with specific chemical properties.

Navigating the path from Investigational New Drug (IND) applications to commercial launch requires precision and innovation. SCL Lifesciences specializes in custom small-molecule API development, offering

1

Face appropriate approach to suit the customer requirements starting from gms to kgs for various phases of development.

2

Regular updating of work progress & TCs with Customer to keep the transparency.

3

Design Tailored Solutions

4

Delivery: Provide High Quality Compounds

5

Quality & Customer Satisfaction Achieved

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