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Category
Method
Developed
Methods
Validated
Methods
Transferred
to the
manufacturing
Site
Oral Solid Dosages 18 32 18
Derma products 18 29 18
Oncology products 7 10 3
MDI 11 18 8
DPI 6 – 2
Nasal 1 – 1
NCE 4 5 3
API 3 2 17
Total 68 96 70
Documents for
Drug Substance
(STP, Specs etc.)
– – 170
In Analytical Research activities for NCE research:
a) New analytical test procedures are developed to
establish the structure and evaluate the quality
of NCE prior to initial biological screening.
During pre-clinical studies, we generated
analytical data for establishing the quality and
setting up specification for the release testing
of Drug substances. The methods used to
release the drug substances which are used in
clinical trials, are validated as per International
Regulatory Standards.
b) Physicochemical properties of new chemical
entity are established and characterization
studies are conducted.
c) CMC related Dossiers, study protocols and
study reports were prepared to support various
pre-clinical studies and clinical trial applications
with Regulatory Agencies.
d) We perform polymorphic evaluation and
salt selection studies on various NCEs drug
substance and drug products.
e) Reference standards of NCE were generated
and supplied to CROs and manufacturing sites.
2. Future plan of action
R & D is working on new molecules in the following
segment;
- Antifungal molecules
- Antibacterial molecules
- Antiasthmatic molecules
- Antidiabetic products
- Antiaging products
- Antiinflammatory products
- Atihyperlipidemic products
- Antiosteoporosis products
- Antiemetic products
- Antihypertensive molecules
- Nutraceuticals
- Sunscreens Products
- Technology – such as micro spheres and
aerosols foam Mousse.
- Development of formulations for Semi regulatory
market.
- Development of formulations for Latin American
market.
- Development of formulations for US market.
- Metered dose inhaler products for India Brazil/
US market.
- Development of specialized NDDS products for
Indian/SRM.
- Nasal sprays for Semi regulatory market and
US market.
TECHNOLOGY ABSORPTION, ADOPTION
AND INNOVATION:
1. Efforts in brief towards technology absorption,
adoption and innovation
Our efforts in the area of technology absorption,
adoption and innovation are based on our own
efforts in R & D. They include improvement
in yield and quality, efficacy, improvement of
processes and development of new processes
with validation studies.
2. Benefits derived:
Benefits derived are introduction of new products,
improvement in the yield and quality, safety and
efficacy of products, cost reduction of products
and processes without affecting the quality of the
products and process efficacy. Our R & D Centre
is recognised by D.S.I.R., Ministry of Science
and Technology, Government of India.
3. Information regarding technology imported
during the last five years – Nil.
3. Expenditure on R & D:
(` in Million)
2010-11 2009-10
a) Capital
Expenditure 89.98 57.97
b) Revenue
Expenditure 569.20 460.55
c) Total 659.18 518.52
d) R & D
Expenditure as
a percentage of
total turnover 5.30% 4.99%
C. FOREIGN EXCHANGE EARNINGS AND
OUTGO
1. Activities relating to exports; initiatives taken
to increase exports; development of new
export markets for products and services; and
export plans; The Management Discussion and
Analysis report forming a part of the Directors
Report deals with the same.
2. Total foreign exchange earned was ` 3339.26
million and outflow was ` 1558.86 million.
Mumbai
Date: 10 May 2011
For and on behalf of the Board of Directors
Glenn Saldanha
Chairman & Managing Director
36
GLENMARK PHARMACEUTICALS LIMITED