Glenmark Generics Limited (GGL) aspires to become one of the leading players in the global generic market. The foundation of this goal is visible in the range of talent and diversified expertise of its scientists. Additionaly, GGL has set up a state of the art facility for both chemical and pharmaceutical development at Taloja, Navi Mumbai, India.

This Research and Development plant would be an integrated facility to provide pertinent opportunities for improving the patient health through developing active ingredients and formulated products. The R &D unit will work in close co-operation with the Intellectual Property Management Cell of the organization to develop cost effective and patent driven APIs and generic formulations that are bioequivalent to the originator product but do not rely on any of the patents that protect the original formula.

The goal of generic R&D is to take advantage of all filing opportunities by doing effective product selection and patent landscaping with a vertical integration of API. This R&D centre will have in-house capabilities to conduct Bio-equivalent studies in its state-of-the-art Clinical Research Unit (CRU) located at Sanpada, Navi Mumbai in India.

The R&D team is committed to deliver a comprehensive catalog of prospects for filing of ANDAs & Drug Master Files as well as registration dossiers and CEP, to ensure timely and successful product launches.

The Centre will have following specialized research & laboratories and focusses on:  

• Process Research for APIs
• Formulation Development
• Analytical Research Development
• Clinical Research & Pharmacokinetics
• Intellectual Property Management Cell

The R&D team comprises:

A scientific staff of over 300, including several PhDs with postdoctoral experience from universities in US / Europe engaged in Process Chemical Development, Formulations Research and Analytical Research.

Formulation Development

The objective of Formulation Development is to deal with all the aspects of Generic drug development from pre-formulation to various regulatory and IP strategies with emphasis on timely development of formulations for ANDA and EU submissions. The focus of the department will be to develop high quality generic products for US, Europe and Argentina markets for a fast and smooth registration process and timely approval.

High quality, technology driven product development is carried out to produce a stable and clinically safe and effective formulation. A variety of dosage forms are being developed as Tablets (conventional, chewable dispersible, orally dissolving, extended release, enteric coated etc.), Capsules, Semi-solids (ointment, cream, gel, lotion) and Liquids (solution, suspension) focusing on therapeutic categories like anti-hypertensive, anti-psychotic, anti-convulsant, anti-depressant, anti-fungal, anti-inflammatory, anti-psoriasis, anti-acne etc. These development programmes covers the First to File (FTF), Paragraph II, III & IV and 505(b)2 opportunities and extended Release products for ANDA as well as EU dossier submissions.

A well-equipped state-of-art formulation facility for all of these dosage forms is located currently at Mahape, Navi Mumbai. Additionally, this location contains an exclusive development set-up for hormone products. The teams involved in the various stages of formulation development include 60 development scientists and a full fledge packaging development and technology transfer group to scale up the lab scale technology to commercial scale.

Analytical Research Lab

The Analytical Research Laboratory is the central analytical facility to support the development of Active Pharmaceutical Ingredient (API) and the Generic Drug Products for various markets at the Glenmark Research Centre.

The Central Instrumentation facility is equipped with modern scientific equipment to develop and validate methods of testing the quality of developed products as per national / international standards and regulations which includes:

• LCMSMS (Liquid Chromatography with Mass Spectrometry)
• NMR (Nuclear Magnetic Resonance Spectrometer)
• Powder X-Ray Diffraction Analyzer
• DSC Differential Scanning Calorimeter
• TGA Thermo Gravimetric Analyzer
• Elemental Analyzer
• Flame and atomic Absorption Analyzer
• FTIR and Number of HPLC and GC Chromatographic Systems

The analytical team is engaged in structural elucidation, development and validation of analytical methods, stability and degradation studies on API, preparation of the Drug Master File and Dossiers for registration in India and other countries.

This Department is fully capable of handling various tasks and provides specific services to various departments. Automation is used extensively to maximize the time available for research-based experiments

Following are the activities carried at ARL

• Analytical method development and their validation as per ICH Guidelines
• Development / preparation of complete specifications for raw materials/starting material, intermediates to Final API and the non- pharmacopoeial excipients and Drug Products
• Forced Degradation Study to study the effect of solvent, alkalies, acids, peroxide , temperature and humidity on the stability of Drug Substances and the Drug Products
• Hygroscopicity Study of API
• Structure elucidation and isolation and characterization of degradation products by UV, IR, Chromatography, DSC, Elemental analysis, TGA, Mass, NMR.
• Characterization of polymorphs using X-Ray diffraction, differential scanning Calorimetry and FTIR
• Structure elucidation and characterization of in house reference standards and impurity standards by UV, IR, Chromatography, DSC, Elemental analysis, TGA, Mass, NMR and XRD.
• Stability study of Drug Substance and the Drug Products as per ICH guidelines

The analytical team is responsible for transfer of analytical methods and specification to various manufacturing site during the scale of the process Technology from R&D to commercial manufacturing of the Drug Substance and Drug Products. Department also provides various scientific in puts in handling the regulatory agencies.

Clinical Research Unit [CRU]

Glenmark has established a Clinical Research Unit to conduct human volunteer bioavailability / bioequivalence studies as a part of its regulatory submissions to countries including the United States, Brazil and the European Union.

Located at Turbhe, Navi Mumbai, the CRU is spread across an area of 15,000 sq. ft. and can now house 72 volunteers participating in clinical studies. The Centre has recently developed a Phase I unit equipped with 8 beds to conduct Phase I human volunteer studies.

Clinical studies conducted at the CRU are in compliance with established operating procedures and regulatory guidelines of various regulatory bodies which include the Drugs Controller General of India [DCGI], the US FDA, ANVISA [Brazil] and the UK MHRA, as well as national and international ethical guidelines including the Indian Council of Medical Research [ICMR], the ICH GCP and the WHO. All the study projects undertaken at the centre are reviewed and approved by an Independent Ethics Committee as per the DCGI guidelines. In February 2006, the CRU received approval from ANVISA [Agência Nacional de Vigilância Sanitária] for conducting bioavailability and bioequivalence studies in human volunteers as a part of its regulatory submissions to Brazil.

The CRU provides fully air-conditioned, hygienic staying and recreation facilities for volunteers participating in the studies. It is also well equipped to handle any medical emergency in its intensive care unit and employs the necessary personnel with required qualification to assist in its various associated functions. Additionally, it has required medical specialists on call to attend to any medical emergency.

Pharmacokinetic Division

The Pharmacokinetic division at Glenmark Research Centre is dedicated in providing leading edge innovative bio-analytical and pharmacokinetic solutions. The strong scientific and regulatory knowledge combined with expertise in bio-analytical method development and experienced scientists who understand the organizational needs for timely and accurate communication allows the Pharmacokinetic division to offer extensive bio-analytical, pharmacokinetic and statistical services.

The State of the art Pharmacokinetics division is spread over 4000 sq.ft and is equipped with sophisticated instruments like LC-MS/MS and HPLCs. The Laboratory operates in the GLP compliant environment to develop and validate the bio-analytical methods for drugs and/or there metabolites in human biological matrix. These validated assays are used for the quantification of the drugs and/or there metabolites from the clinical study samples of the Bio-equivalence (BE) studies. Specific QA procedures govern all activities from sample receipt through data packaging and sample disposal.

The studies performed at the Pharmacokinetic division are in compliance with the standard operating procedures and regulatory guidelines of various regulatory bodies which include the US FDA, ANVISA [Brazil] and the EMEA.

The division has state of the art Watson bioanalytical LIMS^® for sample management and data analysis. The division is fully air-conditioned and environmental condition is centrally monitored by Data Taker^®.

Pharmacokinetics and statistical analysis, sample size estimation etc is done using software tools like SAS^® and WinNonlin^®.

The facility is audited and approved by regulatory agencies like DCGI (India) and ANVISA [Agência Nacional de Vigilância Sanitária] for conducting Bioavailability and Bioequivalence studies in human volunteers as a part of its regulatory submissions to Brazil.

Process Research & Development

In today’s competitive environment, pharmaceutical process chemistry development needs a paradym shift in the industrial chemistry research by not only focusing on the commercially viable cost effective processes but also IPR protected processes. GGL Process R&D will focus on the fundamental understanding of process engineering and the use of on-line monitoring and control techniques to yield capabilities for rapid process development and scale-up together with the creation of highly robust manufacturing routes. The development of practically robust and cost effective processes for the synthesis of active pharmaceutical ingredients has critical implications for subsequent manufacturing and commercialization.

GGL process R&D Team has world class process chemists to deal with the current challenges associated with process chemistry development. This team has expertise in carrying out a variety of chemical reactions and has the expertise to develop a molecule with any structural complexity. Process R&D facility is equipped with international standard fume hoods and walk-in hoods, low temperature circulators, hydrogenators like Parr hydrogenator and autoclaves, ozonizers and other equipments to perform all types chemical reactions.

This facility will also be supported by a Kilo Lab to scale up the flask technology to reasonable scale. This Kilo Lab facility will be able to handle the reaction volume up to 200L and a variety of drying techniques.