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LAB &
PILOT SCALE PRODUCTION
PRODUCT TRIALS AND MEDICAL
SERVICES
We have an
associate Lab and Pilot scale production facilities at Mahad
Near Mumbai & in Hyderabad dedicated exclusively to
us for
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Lab
scale trials of Process Development, Evaluation and Standardisation
in Areas of Bulk drugs, Intermediates, Herbal Actives,
Nutriceuticals and Cosmeceuticals |
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This
is backed by a fully developed Analytical Lab using most Modern
Equipments like Spectroscopy NMR, FTIR, UV, GC Mass Spec and in
Chromatography GC, HPLC, TLC, Column etc. to analyse and verify
Final results and Impurity Profiles of products
manufactured along with providing very essential in-process checks |
Supporting the above two
divisions is our Data Bank Providing
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Rich
source of Synthetic/Natural Routes & Processes of New Molecules |
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Purification
& Maximization of yield datas of new molecules |
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Analytical
Methods for New molecules of Synthetic and Natural origins |
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Finger
Print data of Crude Herbs and Herbarium Profiles of Medicinal Plants |
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Supervising
the above operations is our associate company Spectroline
Laboratories Ltd under the control of Mr Agarwal who has
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More
than 8 Yrs experience in Bulk drug & intermediate
synthesis |
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Interaction
and knowledge of new molecule synthesis being carried
out at various research foundations in India |
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Expertise
in Chiral Synthesis & Chiral resolution technology of new
molecules |
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Fermentation
and DNA genetic engineering |
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MEDICAL
SERVICES OFFERED
We can
offer medical services for the purpose of screening of new drugs so that
discoverer of the drug may use it as a guideline on whether or not to
proceed with further studies.
ACUTE
ANIMAL TOXICITY STUDIES
Through
our association with Medical Colleges and Research Institutes, we can
organise Acute Animal Toxicity Studies for screening purpose. Subacute
and Chronic Toxicity, Carcinogenic and Mutagenic Studies will not be
undertaken routinely.
BIOEQUIVALENCE
STUDIES
We can
offer up-to-date and excellent studies to support the marketing of
generic drugs.
CLINICAL TRIALS
(Clinical Pharmacology III)
Due to
restrictions imposed by the Drugs Controller, India, we
are unable to offer Clinical Pharmacology Phase I and Pharmacology
Phase II. Clinical Pharmacology Phase I and Phase II are permitted only
if the drug is discovered in India
Clinical
Pharmacology Phase III (Clinical trials) is permitted provided the Drugs
Controller, India, is satisfied that the drug is reasonably safe and
effective as assessed from the clinical Pharmacology Phase I and Phase
II studies performed in the country of Origin.
We can
arrange trials to be carried out through us in some of the leading
Medical colleges and Research Institutes in the country with full
assurance of confidentiality.
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