Dr Reddy’s Laboratories GMP Custom API and Dosage Form Services for Clinical Needs

Custom pharmaceutical services (CPS) draws on the company’s expertise in pharmaceutical development and manufacturing to provide custom manufacturing and development services for regulated starting materials (RSM), intermediates, drug substance (API) and drug product (dosage form) needs with an exceptionally wide range of capabilities.

CPS caters to the needs of innovators with a wide range of service offerings which include niche services like high potent drugs, steroids, solutions to complex chiral molecules, activated mPEG’s, life cycle management (LCM) options, combination dosage form products etc.

Small molecule intermediates and API synthesis

Process R&D – analytical R&D and scale-up

• Competence in process research to develop novel, safe and cost-effective processes
• Extensive experience in crystallisation and polymorphic studies
• Method development and validation
• Characterisation and structure elucidation of NCEs
• Impurity profiling including isolation, identification and characterisation
• Stability study per ICH guidelines

Infrastructure

• Dedicated development centers in Hyderabad, India & Cambridge, UK with state-of-the-art synthetic organic chemistry laboratories
• cGMP Kilo lab / pilot plant for scale-up and early clinical material with a class 100,000 clean room
• Class 100,000 cGMP cytotoxic suite for early clinical material
• Chemical and hazard evaluation laboratory
• Certified, qualified and validated equipment: DSC/TG, GC/LC-MS, LC-MS-MS, powder XRD, single crystal XRD, NMR, LC-NMR,FT-IR, CHN analyzer
• GMP API / intermediate contract manufacturing
• GMP API’s supplies as per ICH Q7a guidelines
• Global supply-chain
• Dedicated product managers
• Extensive, 20-year track record with USFDA

Infrastructure

• 8 USFDA inspected, ISO certified and cGMP compliant sites: 6 in India, 1 in the UK and 1 in Mexico
• Over 600 GL/SS reactors from 25L to 20KL

High potent GMP API contract manufacturing

• Containment practiced through air handling, pressure zoning, isolators and personal protective equipment
• Occupational Exposure Limits (OEL) 0.2μg/m3 for 8h TWA

Steroidal API contract manufacturing

• Former Roche/Syntex facility in Mexico acquired by Dr. Reddy’s in 2005
• 12 Active DMFs/VMFs for steroidal APIs

Infrastructure

• Two fully contained bays dedicated to steroidal and High Potent API manufacturing
• Cryogenic reactors capable of -110 °C

Drug product development, scale up and GMP clinical supplies

Formulation development

• Preformulation and formulation development
• Analytical and bioanalytical development
• Clinical trial supply manufacturing
• Pilot scale-up
• Product registration support

Infrastructure

• Fully equipped analytical laboratories with specialised instrumentation
• Fully equipped product and process development laboratories, solid state characterisation
• Stability areas for testing as per ICH guidelines
• Availability of a high precision Xcelodose capsule filling machine, contained in an isolator. Very small quantities of cytotoxic powder (as low as 100µg and greater than 100mg) can be filled with extreme precision into capsules suitable for cGMP clinical supplies.

Contract GMP manufacturing

• Clinical material manufactured in pilot plants and commercial suites support launched products
• Ability to handle cytotoxic oral solids (tablets/
• capsules) and cytotoxic injectables (liq/lyo)
• Conversion of dosage forms to finished packs of HDPE bottles, Blisters (PVC/Alu, PVC-PVdC/Alu, Alu-Alu, including cold form, PVC/ACLAR or aluminium pouches)
• Extensive track record with USFDA, MHRA, MCC, TGA, ANVISA

Infrastructure

• Key manufacturing site in India has several modular commercial manufacturing suites
• Three pilot plants
• ISO 9001, ISO 14001 and OHSAS 18001 certified

Chiral technologies and services

CPS has assembled an industry-leading portfolio of technologies with specific strengths in chiral chemistry. Our main focus is on catalysis as this provides long-term advantages and sustainability for chemical processing. Technologies include: asymmetric hydrogenation, hydro-formylation and biocatalysis – working together with customers we have proven ability to select and combine technologies to deliver optimal solutions to even the most challenging of projects.

Activated mPEGs

Over the last five years, CPS has manufactured and supplied activated mPEGs for the conjugation of proteins, antibody fragments and peptides; to improve the stability and the pharmaco-kinetic properties of biologic drugs. With outstanding GMP capabilities and back integration to high purity mPEG-OH, we can guarantee the quality and security of supply of our activated mPEG products.