Activities

At Alembic Pharmaceuticals, we recognize that Research and Development is vital for our survival and growth as a leading pharmaceutical firm in India. Research and Development is focused on fermentation technology, strain improvement, industrial enzymes, non-infringing process developments for API's & intermediates, development of innovative formulations, NDDS. The Department of Scientific and Industrial Research (DSIR) of the Government of India has recognized Alembic's Research and Development Unit since 1975.

Research and Development efforts at Alembic Pharmaceuticals are focused on 3 broad categories

Chemistry and Synthesis

Activities pertaining to APIs/ Bulk Drugs Development

We develop cost-effective and eco-friendly processes for drugs and their intermediates. We have gained significant expertise in developing processes for macrolides and ketolides apart from handling various organic reactions. The non-infringing processes developed by R&D lead Alembic Pharmaceuticals to file DMF’s in the regulated market. Process development of API's for generic markets remains our key focus. The Company is one of the two organisations in India which produce phosgene based chemicals. Our Strenghts in Process Development are :-

  • Development of novel / non-infringing process for APIs
  • Development of environmentally friendly processes
  • Development of chiral APIs
  • Ability to comply with ICH guidelines
  • Synthesis, isolation and characterization of impurities.
  • Expertise in handling polymorphic reagents
  • Expertise in very low (-40 %) temperature reactions
  • Expertise in handling organometallic reactions
  • Polymorphism
  • Synthesis of novel polymorphs
  • Synthesis of amophous forms using lyophilization spray dring or solvent evaporation ttechiques.
  • Development of novel process for new polymorphs
  • Quantifications studies for polymorphs using IR / DSC / XRD
  • Determination of polymorphs stability

Equipped with state-of-the-art analytical instruments like XRD, LC/MS/MS, Capillary Electrophorosis, Proton and carbon NMR, our Analytical Development laboratory is the backbone for development and validation of analytical methods besides making impurity profiles and quantification of polymorphs. As many as 100 scientists work on process innovation and simplification, cycle time reduction and continuous process improvement.

The Company’s R & D strengths are in developing intellectual property in the area of non-infringing processes and resolving complex chemistry challenges. A strong IPR cell at Alembic Pharmaceuticals facilitates the scientists in creation and protection of intellectual property with necessary documentation.

Our operations are supported by well documented systems and procedures and are ISO-9000 certified. A separate department called DQA (Development QA) is dedicated to R&D and ADL to guide the scientists to achieve compliance with respect to QA and RA requirements.

Our fully equipped Kilo lab, pilot plant and manufacturing plants and their sophisticated infrastructure give us a competitive edge in R&D operations.

Formulations Development

Activities pertaining to Formulations Development

Pharmaceuticals Research is an integral part of R&D, comprising of Formulation, Packaging and Analytical development departments. We deliver various kinds of dosage forms for manufacturing locations complying with their regulatory requirements.

The dosage forms include solid dosage form, oral controlled release, Pelletization, and pulmonary drug delivery systems.

The main focus of Pharma Research is on value-added, difficult-to-make 'niche' products with patented technologies. Our research capabilities have delivered the various formulations for domestic markets. Now our focus is on developing the products for advanced markets such as US & Europe.

Our vision, product selection criteria and unique product development strategy will enable us to file ANDA's in US & Europe market.

Endorsing our endeavor to build and position Alembic Pharmaceuticals a research-based Organization the NDDS program is yet another step in that direction. Driven by a team of enthusiastic and bright young scientists, the Company's current focus on Drug delivery Research is in the area of oral-controlled release-systems.

The Company is developing products in the area of Oral Controlled Release Systems, using its patented 'Platform Technologies’.

Apart from these we have plans to develop various technologies such as:

  • Swellable Gastro floating Systems
  • Osmo micro sealed Gastro retentive Drug Delivery
  • Taste Masking
  • Pulmonary drug delivery system
  • Trans dermal drug delivery system

Contract / Collaborated Research

Activities pertaining to Contract / Collaborated Research

Alembic Research Centre, the R&D division of Alembic Pharmaceuticals Limited, is a rapidly growing Contract / Collaborated Research services organization providing a wide range of services to global research based pharmaceutical and biotech companies.

Alembic Research Centre is an R&D focused organization, partnering with customers worldwide to provide technical expertise to expedite projects/ product development in a time-bound, confidential and cost-effective manner.

Alembic Research Centre is a well-equipped R&D center spread over an area of 120000 sq. ft. and has a rich pool of over 250 scientists that bring together more than 850 man-years of varied scientific experience spanning across all domain of services.

ALEMBIC RESEARCH CENTRE OFFERS VALUE-ADDED SOLUTIONS IN THE FOLLOWING DOMANS

Chemistry
  • Custom synthesis & compound supply of NCEs
  • Process chemistry at gm to Kg levels
  • Process innovation,development and optimizations
  • Manufacturing of intermediates {Non GMP]
  • Supply of API's as per GMP standards
  • Impurities isolation & synthesis
  • Analytical chemistry services

BIOEQUIVALENCE / BIOAVAILABILITY

Clinical
  • Bioequivalence assessment of Generic dosage forms
  • Drug interaction studies
  • Food effect bioavailability studies
  • Different route of administration {Oral,IV,Im,Buccal,Rectal etc}
  • Bioanalytical
  • Development and validation of new analytical assay methods
  • Adaptation and revalidation of sponsor's assay methods

Alembic Research Centre has a multidisciplinary team based approach to the various challenges posed by the drug discovery industry.
We trust in integrity confidentiality and quality of our research solutions and can be a valued partner to your Research team and drug discovery process.