We Have More Success Stories

    At Chemigran, we support global pharmaceutical companies by solving complex supply chain challenges across R&D, regulatory, and manufacturing stages. The following real-world case studies illustrate how our expertise ensures regulatory compliance, supply security, and long-term market success.

    Case Study 1 - Rapid API Replacement Prevents Product Disruption​

    European Specialty Pharmaceutical Company​

    Challenges

    1. Industrial-grade Coumarin is abundant but GMP production is not economically feasible given the limited scale of pharmaceutical usage.
    2. Decision from client’s sole GMP-qualified supplier for Coumarin to cease production

    3. Supply chain of credentialed API was disrupted and client’s finished product continuity threatened due to supply chain disruption.

    Chemigran Solutions

    1. Leveraged Chemigran’s global partner network to identify a manufacturing site capable of establishing GMP-compliant production under strict timelines.
    2. Supported GMP setup, process scale-up, and DMF preparation.

    3. Delivered validated commercial supply in 6 months.

    Through Chemigran’s swift intervention, the supply chain was restored, regulatory compliance upheld, and product continuity maintained without disruption.

    Case Study 2 - Specialized API for 3D-Printed Formulation Trials

    Local Pharmaceutical Innovator

    Challenges

    1. Development of 3D-printed dosage forms requiring multiple APIs in small, customized batch sizes.
    2. Conventional suppliers unable to support low-volume GMP-compliant production.
    3. Limited availability of fully credentialed suppliers with traceability and regulatory documentation.
    4. Client’s clinical trial timelines at risk of interruption due to limited GMP-compliant API availability.

    Chemigran Solutions

    1. Engaged Chemigran’s partner network to identify and qualify GMP-compliant suppliers capable of flexible production volumes.
    2. Structured tailored supply agreements aligned with clinical trial phases.

    3. Delivered full regulatory documentation packages, including CoAs, stability data, and compliance certificates, within 3 months.

    Chemigran’s proactive support safeguarded clinical trial timelines, ensured full regulatory compliance and traceability, and enabled flexible supply continuity for ongoing development.

    Case Study 3 - 25-Year Oncology Partnership from Development to Commercialization

    Global Pharmaceutical Partner (Oncology: Etoposide Project)

    Challenges

    1. Required long-term support across the entire product lifecycle:
    • Early development
    • Impurity profiling
    • Regulatory credentialing
    • Global market expansion
    • Ongoing regulatory maintenance
    1. Global market continuity dependent on stable long-term partnership:
    • Secured consistent API supply for international markets
    • Provided ongoing regulatory and technical support
    • Enabled risk mitigation through reliable, scalable production

    Chemigran Solutions

    1. Supplied initial lab-scale API samples and credentialed reference comparators.
    2. Managed impurity profiling, analytical method support, and regulatory documentation preparation.
    3. Coordinated GMP scale-up, commercial manufacturing transfers, stability programs, and DMF filings.
    4. Provided ongoing regulatory updates and compliance management across multiple global markets for over 25 years.

    Chemigran enabled seamless development-to-commercialization support, sustained global regulatory compliance, and over 25 years of uninterrupted market access through a trusted long-term strategic partnership.

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