| NPIL's
Global Manufacturing Plant
Based
near Hyderabad, NPIL's APIs and Intermediates plant is one
of the very few in India with very comprehensive international
protocols and certifications. This gives a definite edge to
NPIL's export strategy as the outsourcing partner of choice
for pharmacos worldwide.
The plant is one of the very few USFDA plants
in India. The plant is unique in that it has USFDA approval
for the entire facility and not merely a product line, without
and deficiency or non-conformity i.e. without any 483s. It
is also accredited and approved by MCA of UK, TGA of Australia
and the European and Canadian Drug Authorities. The plant
also has ISO 9001 accreditation.
NPIL can now take advantage of the opportunities
that will emerge in the bulk actives and intermediates market
for outsourcing of both on patent and off patent drugs in
the regulated markets of Europe, US and Japan. Capabilities
will be critical in this business - manufacturing, process
development (integrating with R&D), IPR protection, BD
and supply chain management.
Significantly,
NPIL is also well placed to offer manufacturing services across
the entire life cycle of a product. Our capabilities today
include not just lower cost dosage manufacturing, but the
ability to manage costs through process innovation and the
skills to aid in formulations R&D development and new
dug delivery systems. We will also create further market opportunity
by partnering with companies across the entire product life
cycle, including the development stage. The company's capabilities
enable it manufacture and partner at each stage of the life
cycle. Our FDA approved manufacturing plant is best-in-class
and is capable of all types of reactions.
The manufacturing facility with a pharma
area conforming to Class 100000 comprises two dedicated facilities
and one multipurpose plant.
At one of the largest single location AP/intermediate
facilities in India, NPIL can offer research capabilities
and manufactures bulk actives and drug intermediates in a
completely environmental friendly ISO 14000 certified environment.
There are two dedicated manufacturing blocks
and one multi purpose plant with a capacity of 165 reactors
and a production capacity of 460 kilo litres. It has 38 centrifuges
and 28 dryers.
The
company manufactures Dilitiazem, Ketaconazole, Verapamil hydrochloride,
Gabapentin, Benzethonium Chloride, Pentoxifylline, Itraconazole
and Oxymetazoline hydrochloride. In addition, it manufactures
intermediates for Dilitiazem hydrochloride, D(+) acid, Cis(+)
hydroxylactum, Ketaconazole, Cis (+) bromobenzoate, Cis Tosylate,
Cis mesylate, venlafaxine HCl, Flucanazole, Rosiglitazone,
Cetrizine hydrocholride, Valdecoxib, Zaleplon and Leflunomide.
A 2000 square feet R&D facility
enables the company to process and develop new APIs and intermediates
while also supporting its existing products by developing
efficient processes.
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