Indoco’s state-of-the-art R&D Centre is located at Rabale, Navi Mumbai. This facility is spread over an area of 100,000 sq. ft. and is approved by the Department of Scientific and Industrial Research, Ministry of Science and Technology, Government of India.
The facilities at the Centre include, Synthetic Chemistry Labs (APIs), Formulation Development, Analytical Method Development, Regulatory and Intellectual Property Rights Cell. The API section has capabilities to synthesize APIs, work on process improvement, as well as development of non-infringing processes for APIs and intermediates.
The F&D section is engaged in development of dosage forms – solid & liquid orals, creams & ointments, ophthalmic preparations, small volume parenterals and dental products. It is also engaged in research in the area of modified release products like sustained release and controlled release tablets. The Regulatory and IPR Cell is equipped with online patent search tools and syndicated databases with access to various libraries and are engaged in preparing regulated market ANDAs and dossiers in CTD format.
The robust R&D capabilities within the company for both ‘Process Designing’ and ‘Product Development’, reflects our commitment to be a leader in the generic space.
API R&D focus:
Custom chemical synthesis of molecules & intermediates (R & D, Preclinical and Clinical Phase)
Contract Research: Process Chemistry Research & Development
Non-Infringing process design & scale up
Analytical Research (Analytical Method Development, Validation, Impurity Characterization, Impurity profiling & Polymorphic Studies)
Intellectual Property Management
Formulation R&D focus:
Complex Ophthalmics and Injectables
Controlled Release Technologies
Development of “Difficult to Formulate” Products
Dental Care Products
Neutraceutical Product Development
Development of all kinds of dosage forms
Capabilities:
Fume Hoods: 22 Nos. (Waldner - Germany)
Lab Furniture: Waldner - Germany
Rotavapor: 10 Nos. (Buchi)
Hydrogenator: 2 No., (2 Ltrs. &1 Ltr)
High Vaccum pumps: 15 Nos. (Vaccubrand - Germany)
Operating Temperature: Low(-40 Deg. C.) High(250 Deg. C.)
Lyophilizer: (Thermo)
HPLCs Alliance, with PDA, UV Detector & sample cooler heater & Analytical method development software
LC-MS/MS
GC-HS-MS
X-Ray Diffractometer
Modulated Differential Scanning Calorimeter
Thermogravimetric Analyser
GC with TCD & FID Detectors
Preparative HPLC
Flash Chromatograph
FTIR
Particle size Analyser
Lyophilizer
Grignard Reaction
Suzuki Reaction
Baeyer - Villiger Oxidation
Hofmann Rearrangement
Negishi Reaction
Ritter Reaction
Kolbe Carboxylation
Reformatsky Reaction
Oppenauer Oxidation
Vilsmeier - Haack Reaction
SNAr Reaction
Willgerodt Reaction
Birch Reduction
Gomberg Reaction
Skraup Synthesis
The Kilo Lab Facility at Rabale is for the production of gram-to-several kilogram quantities of APIs and key intermediates for pre-clinical phase to phase II clinical studies Pilot Plant facility is of a modern, state-of-the-art facility developed to manufacture clinical materials for the pharmaceuticals industry.
Indoco pilot facility is versatile kilo lab and able to perform a wide variety of reactions and complete multi-stage intermediate and API processes.
Batch size : 1 to 20 kg
The Pilot Plant is situated at the Company's solid oral facility, Plant I in Goa. The Plant has a manufacturing area with relative humidity upto 40 percent with capability to handle aqueous and non-aqueous coating.
The machinery and equipment in Pilot Plant are prototype of the ones installed in the R&D facility in Mumbai and the main manufacturing area. This helps for scale-up from the R&D stage. The pilot plant is useful for manufacturing exhibit / validation batches, so also, the high value products, which are usually required in small batch sizes.
The Pilot Plant has been approved by the UK-MHRA, Darmstadt-Germany and ANVISA-Brazil.
Batch size : 15 to 60 kg