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Research & Development

Innovation at the Heart of Everything We Do

Aarti Pharmalabs Limited (APL) has transformed from a vendor to a preferred partner. Our two cutting-edge R&D facilities, located in Gujarat's Dombivli and Vapi, consistently strive for:

  • Route Scouting and Design
  • New Product Development
  • Process Optimization and Scale-up
  • Life Cycle Technology Management

Establishing ourselves as a global pharma API and intermediates manufacturer in the pharmaceutical sector is our strategic objective. In the long haul, we want to further embrace open innovation and build a worthwhile, sustainable nutraceutical companies.

We are prepared to seize development possibilities and play a crucial part in establishing our presence in the international pharmaceuticals sector, supported by our knowledge, experience, technical prowess, and resources organisation.

Expertise in specific chemistry

APL has developed expertise in various chemistries and to name a few:

  • Ammonolysis
  • Condensation
  • Chlorination
  • Denitrochlorination
  • Diazotization
  • Ethylation
  • Halex (Fluorination)
  • Hydrogenation
  • Nitration
  • Sulphonation

  • Alkylation
  • Acetylation
  • Amino Acid Esterification
  • Aldol Condensation
  • Asymmetric Hydrogenation
  • Benzidine Rearrangement
  • Biocatalysis
  • Bromination/Sandmeyer
  • Butyl Lithium Reaction
  • Balz-Schiemann Reaction
  • Boron Chemistry
  • Carboxylation
  • Cynation
  • Cyclocondensation
  • Chichibabin Reaction
  • Chiral Chemistry (Implementation of enzymatic technology)
  • Dehydrogenation
  • Denitrochlorination
  • Diborane Reduction
  • Darzens Glycidic Ester Condensation
  • Darzens Glycidic Ester Condensation
  • Esterification
  • Epoxidation
  • Fluorination: KF, AHF, DHF and Balz Schiemann
  • Friedel Crafts Reaction
  • Flow reactor technology at commercial scale
  • Grignard's Reaction
  • Hydrogenation/Dehalogenation/Reductive amination
  • Hetero Diels Alder Reaction
  • Kolbe Schmitt Reaction
  • Knoevenagel Reaction
  • Methoxylation
  • Meerwein-Ponndorf-Verley Reduction
  • Michael Addition
  • Negishi Reaction
  • Oxidation
  • Oppenauer Oxidation
  • Organometallic Coupling
  • Grignard/Kumada/Suzuki
  • Phosphorylation
  • Phosgenation
  • Ring Alkylation and N-alkylation
  • Sulfonation
  • Silylation
  • Sandmeyer Reaction
  • Suzuki Coupling
  • Swern Oxidation
  • Skraup Reaction
  • Steroid Chemistry
  • Triphosgene Reactions
  • Ullmann Reaction
  • Vapour phase reaction:
  • Ammoxidation/Isomerisation
  • Vilsmeier-Haack Reaction
  • Wittig Reaction
  • Willgerodt Reaction

Analytical Capability

APL has a state-of-the-art analytical laboratory with an experienced and qualified team of scientists engaged in

  • Analytical Method Development, Calibration and Validation
  • Structural Identification and Elucidation
  • Impurity, Byproduct and Metabolite Isolation
  • Analytical Technology Transfer and Documentation
  • Stability Studies as per ICH guidelines

Typical infrastructure at the Analytical Development laboratory consists of specialised equipment such as HPLC, GC, LCMS, GCMS, Flash-Chromatography, ICP-MS, Particle Size Analyser, NMR and other equipment such as colourimetry, auto-titrator, stability chamber etc.

Process Chemistry Capability and Infrastructure

  • State of the art synthesis and process development laboratories
  • With more than 20 PhDs and 80 postgraduate scientists

Process Chemistry Infrastructure

Reaction workstations are established to conduct various unit reactions

Atmospheric

<p>Our labs are equipped with modern experimental set-ups to conduct a range of atmospheric pressure reactions. Fully automated advanced jacketed glass reactor set-ups help in easy control of parameters such as temperature, dosing, pH control dosing while capturing real-time data. We also conduct cryogenic (-80<sup>o</sup>C) and high temperature (>150<sup>o</sup>C) reactions regularly using this cutting-edge set-up.</p>

High Pressure

<p>A dedicated fully automated high-pressure section has been developed with ballast-proof walls. The reactors are remotely controlled by PLC to avoid any exposure to research personnel and meet the best safety standards. Further, software can control gas feeding, temperature control, cooling, liquid feeding, etc., while capturing real-time data. Reactors with various MOCs like SS316, Hastelloy C22, Zirconium, Tantalum, etc. are part of the facility.</p>

Parallel Reactors

<p>Parallel reactors are being used for high throughput screening of reaction parameters and process optimization using statistical design of experiments (DOE) software. Parallel reactors are also used for deviation/What-if studies during process development to optimise development and optimisation time.</p>

Availability of Process Analytics Tools

<p><strong>React-IR:</strong> Understanding Reaction Kinetics<br /> <strong>FBMR:</strong> Monitor and Control the particle size<br /> <strong>Colorimetric probe: </strong> Understanding heat of the reaction</p>

Mimic Unit Operations using lab equipment such as:

<p>Jacketed Agitated Nutsche Filter, Centrifuge filter, solvent recovery unit<br /> Additionally, our facility is equipped with an automated distillation apparatus that can achieve separation of compounds with boiling point difference in the range of 1<sup>o</sup>C. This distillation set-up provides flexibility for changing theoretical plates and reflux ratio. The data obtained from the lab helps while scaling up and designing pilot and plant scale distillation set-up. The distillation set-ups are available in different MOCS: Glass, SS316, etc. to ensure different chemistries can be accommodated.</p>

Waste Pre-treatment Studies

Our waste pre-treatment studies aim to reduce the environmental load at process design stage while targeting various environmentally important parameters such as:

  • COD
  • BOD
  • TSS
  • pH
  • TDS
  • Ammoniacal Nitrogen content
  • Bromide content
  • Chloride content
  • Sulphate content
  • Metal content

Process safety Studies

Health and Environmental Hazards:

There are essentially four major hazards in chemical processing:

Health and environmental hazards are identified through the in-house SDS generated through GHS compliant software.

Chemical Reaction Hazards data generation and its interpretation

The chemical reaction hazards that may be generated during the chemical processing/storage. The three major chemical reaction hazards are:

  1. Thermal instability of reactants, reactant mixtures and products (including any intermediates, residues, wastes, potential contaminants and by-products)
  2. Exothermic reactions which raise the temperature to produce decomposition reactions or violent boiling
  3. Gas evolution

A dedicated team equipped with advanced laboratory equipment conducts different process safety studies.

  1. Thermal stability studies using
    1. Differential scanning calorimeter – DSC
    2. Thermal Screening Unit – TSU
    3. Vent size packaging – VSP
  2. Exothermic Reaction Studies using
    1. Reaction Calorimeter – RC1 (Atmospheric and Hastelloy Pressure vessel)
  3. Gas Evolution and Vent Sizing Studies using
    1. Gas Evolution measurement apparatus along with reaction calorimeter
    2. Thermal Screening Unit – TSU
    3. Vent size packaging – VSP
  4. Chemical reaction Hazard assessment through
    1. Accelerating rate calorimeter-ARC

Fire and Explosion Hazards:

We carry out thermal stability tests and other fire and explosion tests especially for powder safety testing. For quick results of powder safety testing, we have also extensive tie ups with third-party service providers. The data from these tests is assessed in-house in our laboratories.

We are also building capabilities and infrastructure for fire and explosion hazards such as

  1. Minimum ignition energy-MIE
  2. Flash point

We undertake Hazop studies during the R&D process development to ensure our processes are inherently safe for commercialization

Material Safety Management and Product Stewardship:

We have developed a Safety Data Sheet (SDS) database of all the GHS compliant products and chemicals being used at APL. This online database is readily accessible to all employees. We also have in-house capabilities to retrieve and generate new MSDS for development products. Being a ‘Responsible Care’ company, such capability of material safety management also helps in establishing product stewardship for existing and new products which helps our employees and customers to take appropriate action and care while handling our chemicals and products.