In
the year 1993 we entered the market with the aim to give our
customers a complete satisfactory package of products and services.
Since then we have worked to achieve and maintain our aim. The
technologies we give to our customers are well researched and tested.
Our on-time services have made us popular amongst our clients. Since
our inception, we are focused on making specialty whitener and Pharma
API's. The ISO 9001:2000 certificate is there to our credit and we
are working for WHO GMP certification and EU GMP certification.
About
Nivika Chemo-Pharma Pvt. Ltd.
We
are in sync with the pace of the market. The experts in our team very
wisely synchronize the changing technology to our regular working.
Before synchronizing there is a complete research and discussion, and
the steps taken, are the best for our customers. Thus we are always
equipped to give our clients the latest and the best in the market.
The
team of experts associated with us is the most integral part of our
company. These experts widely synchronize the changing technology in
our operations and try to offer the best to our clients. Before this,
they conduct in-depth research to assess the market needs and
customers' preferences so that we can meet clients requirements in
best possible manner. This is one of the key factors that we are able
to satisfy our valued customers in an efficient manner. The
assortment provided by us has higher demand in various countries. We
export varieties of products to Europe, US, Japan, Canada, Australia,
Israel, Turkey, Korea, and many more. In addition, our company
imports internationally acclaimed products from China, Germany,
Austria, and Japan.
We
are a reputed manufacturer of different types of Pharma APIs, which
are developed on state-of-the-art manufacturing site. All the
products provided by us are of unmatched quality and can meet diverse
needs of customers efficiently. The complete production process is
carried out under the guidance of qualified and experienced
personnel.
R
& D Capabilities
- Nivika
supports clients
- Route
Scouting
- Small
Scale Synthesis
- Scale
UP (GMP / Non GMP)
- Process
research
The
competence of the scientific staff comprises concurrent as well as
advanced technologies like metal organic reactions, chiral synthesis
etc. The scale up laboratories are well equipped to carry out these
reactions on larger scale including caryogenic & high pressure
reaction (presently up to 20 bars) Nivika blends world class
facilities with intellectual capital to meet the specialized R&D
needs of innovator companies.We are geared to ensure the speed and
excellence of execution and scalability.
Manufacturing
Facilities
Nivika
has infrastructure to manufacture Active Pharmaceutical ingredients
and advance Intermediates at different capacities such as:
- Tonnes
per month
- 100
kg levels per month
- 10-15
kg levels per month
Nivika
Manufactures Active Pharmaceutical Ingredients of various therapeutic
categories such as Analgesic, Anti- Inflammatory, Anti-Hypertensive,
Anti-Diabetic and others Manufacturing facility at Nivika company has
set of equipments such as Stainless Steel and Glass line Reactors,
Centrifuges, Dryers, Filters, Blender, Multi Mill, Sifter etc.
Manufacturing is undertaken by adhering to cGMP guidelines, Nivika
develop the below facilities:
- Clean-rooms
with Epoxy finishes, Flush doors, windows and light fixtures for
powder processing areas.
- Air
Handling systems with controlled temperature,humidity, Differential
pressure, Air changes, HEPA filters.
- Process
water systems with Reverse Osmosis and De-mineralization.
- Manufacturing
team comprising of chemical engineers and science graduates well
versed with good manufacturing practices.
- Maintenance
Team comprising of electrical and mechanical engineers well
experienced in preventive and breakdown maintenance.
Quality
Assurance
Nivika
preserves a tradition of dedication and professional integrity in the
pursuit of excellence by performing systematic and planed activities
to enable our organization to better compete with others. Below are
the features of Quality assurance.
Department
at Nivika:
- Quality
assurance is independent of Manufacturing and Quality control.
- In-process
quality is checked during manufacturing.
- Validation
of facilities, equipments, process, products and cleaning as per
master plan.
- Responding
Complaints.
- Handling
audits of customers and regulatory bodies.
- Storage
of records and samples.
- Stability
studies.
- Documentation
control.
- cGMP
Traing.
- Release
of batch for marketing
- Conducting
Supplier Audit as well as Internal Audit.
Regulatory
Affairs
With
focus to cater consistently to the highly regulated markets of
European Union, USA and Japan, Nivika has developed regulatory
affairs department comprising of qualified and experienced persons in
the field. Regulatory affairs at Nivika takes care for registration
of products, submission of drug master files etc. , by co-ordinating
with all the departments including top management. It plays a
significant role in keeping up to date with latest registration
requirements of different countries.
Quality
Control
In
order to assure zero rejection of its product, Nivika has put forward
utmost efforts by providing latest sophisticated instruments and
training entire team continuously to not only meet but excel in the
standards set by international regulatory bodies and customers.
In-house testing facility at Nivika comprises of the Instruments such
as HPLC, GC, with headspace, DSC, FTIR, Laser based Partical Size
Analyser, UV-Visible Spectrophotometer, Polarimeter, Colorometer;
Auto Titrator etc.
Over
and above, it also has facility to conduct long term and short term
stability studies as well as full-fledged Microbiology department.
For other special testing requirements such as X-ray diffraction and
NMR, Nivika takes the support of government recognized laboratories.
Why
Us?
Over
the past years, our products have gained higher demands in the global
market. We take pride in boasting that customers' give us repeated
orders to help them cater to diverse requirements. All the chemicals
developed at our manufacturing unit are the consequence of dedication
and hard work of our talented workforce. They keep them updated with
all current market needs and customers' preferences, which help them
introduce right assortment. Furthermore, following are some of the
factors that distinguish us among competitors:
- Robust
infrastructure
- Quality
check of products
- Wide
distribution network
- Timely
delivery of consignment.
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