Heparin Update…
The recent drug
recalls of Heparin, by the US FDA in the US followed by other countries like Japan,
Germany, Italy, Australia, France, Denmark, Switzerland have re-iterated the importance of the Organization’s
experience, capabilities and systems to manufacture and test the product
far beyond the monograph’s requirements. The recalls which got
triggered by the number of deaths
and adverse reactions
caused by using Heparin from the Chinese Origin has once again proved
the criticality of the traceability of the source as well as the
integrity of the supply chain manufacturing process.
With more than three
decades of experience as pioneers of Heparin Technology in India, Gland
has built-in capabilities and systems to screen the raw material
Heparin before compounding into Injections and has the safeguards to
detect all impurities.
Gland
Pharma has established fully integrated manufacturing facilities
starting from Heparin API (Active Pharmaceutical Ingredients) to
finished products Heparin Injections. Gland Pharma manufactures Heparin
Injections in a state-of-art and world- class facilities inspected and
approved by USFDA. The
USFDA- which has attributed the allergic reactions/deaths caused, to the
toxic and additional impurity found in the Heparin raw material of
Chinese origin- has recently outlined new testing procedures to detect
these impurities beyond the scope of the normal pharmacopoeia. All the Heparin batches manufactured by us are evaluated by chemical, Instrumental and Pharmacological techniques to investigate the impurities/contaminants. Nuclear
Magnetic Resonance (NMR) methods and Capillary
Electrophoresis (CE) techniques
used for the detection have shown that the additional peak referred
by the US FDA and attributed to the contaminant causing allergic
reactions is not present in our products.
Gland has also examined its products for their efficacy and safety through Pharmacological methods on animal models. In
the light of the adverse reactions of an extremely serious nature and
the findings of the US FDA, exhaustive studies were undertaken by us on
the injections manufactured by us in the recent past, as well as the
Heparin substances that went into the making of them. Our
findings are that there were NO CONTAMINANTS
of the type detected by FDA; and PURITY
of Heparin substance remained consistent. We
have also received NO COMPLAINTS
from either India or the 25 countries to whom we export. We
wanted to share our confidence with the medical profession that our
knowledge and understanding in this particular field, backed by decades
of manufacturing experience stand by us in making safe
and efficacious Heparin products. Again it is this knowledge that
qualified us and enabled us to manufacture a full range of Basic
L M W Heparins including Enoxaparin. As
you perhaps know, that amongst the 20 odd Heparin manufacturers in
India, Gland Pharma stands out unique as the Only
Indian Manufacturer of Basic L M W Heparins which has become
possible because of our Profound Understanding of the Chemistry;
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