SPECIALIZED IN LIQUID STERILES - Global …...High speed labelling machines for ampoules / vials with dedicated conveyors ensure through output. Blister packing capacity of 3.00 lakh

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Registered Office

No. 1/5, Santosh Complex, Armugam Circle

Basavanagudi, Bangalore - 560 004

E-mail : [email protected]

Plant

32, Sipcot Industrial Complex, Phase I, Hosur - 635 126, India.

Tel: +91 4344 406101 Fax: +91 4344 279845

www.globalpharmatech.com EU GMP Compliant

SPECIALIZED IN LIQUID STERILES

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We have the energy, technical expertise, agility, talent and resources to achieve our

vision. In our journey to achieve this vision, our relationship with our customers is

far more than just business - it is a partnership with the objective of achieving a

highly productive relationship bonded by value of trust and commitment, driven by

close interaction to deliver projects to our customers on time.

Dr. Bhaskar Krishna, Managing Director

Global Pharmatech is a world class manufacturer of high quality pharmaceutical

products both on contract and on its own account. It maintains the highest

degree of safety standards in conformity with those prescribed by authorities in

E.U and USA. We consider product safety and customer satisfaction as the

cardinal objectives of this enterprise.

T. Thomas, Chairman

www.globalpharmatech.com

ABOUT US

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A one stop destination for Novartis Switzerland, Ranbaxy, Abbott Therapeutic Segments

formulation development and and Wockhardt. We undertake commercial batch

specialized manufacturing of liquid manufacture of a wide range of liquid Location Advantagesterile injections and ophthalmics. sterile injections in glass ampoules Global Pharmatech located at Hosur, and vials for human and veterinary

One of the largest contract Tamil Nadu, 35 kms from Bangalore, use, which are as follows:manufacturers of sterile liquid the IT hub of India. The facility is

parenterals and ophthalmics. easily accessible by rail, road and

air and is close to two majorManufacturers of Small Volume sea ports - Chennai and Mangalore.Parenterals for human, veterinary

& ophthalmic use. Plant Design

Box-in-box type production facility Having WHO GMP & ISO 9001

design which enables complete certification, Global Pharmatech is EU

protection of core aseptic areas. The GMP Compliant & renewal is under

entire facility has been designed to consideration. We have been audited

ensure a linear flow of material and successfully by International quality

personnel to avoid mix-up.auditors from GSK UK, Pfizer USA,

WE ARE

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Our aim has been always to deliver an Our operations involve utilisation of the 100% compliance with quality

unmatched customer experience best practices in the industry supported regulations and continuous

through: by state-of-the-art equipment and a upgradation of technology.

laboratory manned by top notch Offering outstanding quality of sterile An uncompromising approach to professionals. Top multinational liquid injectables and ophthalmics observance of the timing for companies have seen this value in us in glass vials and ampoules. registration, supply and launch.which has earned us their unstinting

Continued quality consciousness and support over the last several years. Timely communication to our value addition at every stage of the customers With a strong customer focus, our project. of project status and visibility.endeavour has been to

Meeting the most demanding needs Implement industry standards in of our customers. production and in quality control.

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Vitamin formulations Anti-malarials

General antibiotics Anti-emetics

Anaesthetics Anti-anaemics

Cardiovasculars Steroids

Psychotropics Analgesics

Antihistamines

Global Pharmatech was started as a specialised liquid sterile manufacturing company in 1995 and is today a

leading manufacturer of liquid sterile injectables and ophthalmics.

Special ized manufacturers of l iquid steri les

EU GMP Compliant



The essence of our vision is to manufacture world class pharmaceutical formulations with the highest standards of customer satisfaction. In pursuit of

this, we achieve the best standards in production and sustain continuous improvement of our quality management system and keep raising the bar.

MANUFACTURING FACILITIES

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Small Volume Parenterals Annual Capacity / Year

Ampoules (0.5 ml to 10 ml) 72 million units (based on 2 ml fill volume)

Vials (2 ml to 25 ml) 36 million units (based on 5 ml fill volume)

Capacities and Capabilities

Global Pharmatech plant is spread over 30,000 sq mts with over 10,000 sq mts of cGMP production area with dedicated and state-of-the-art manufacturing facility.

Compact integrated lines for filling in glass ampoules and vials are supported with total back-up facilities.

We offer customized packaging apart from standard blister packing for the

above finished dosage forms.

We can tailor a solution to the customer’s specific needs, working closely with

them to integrate with their supply chain system at any stage that they need,

from formulation development, pilot batch manufacturing, process development,

optimization to commercial manufacturing.

Dedicated Vial Line

The EU GMP compliant Vial Line is equipped with world class

manufacturing equipment which include

BOSCH washing and tunnel sterilizer

140 vials / minute filling

LDPE (Low Density Poly Ethylene) Plugs / Rubber Stoppering & Sealing

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Dedicated Ampoule Line

The EU GMP compliant Ampoule Tunnel Line puts Global Pharmatech in the

distinguished group of EU approved sites in India, reiterating our stature as

amongst the very best in the manufacturing of high quality liquid steriles. The

ampoule filling line is backed by the state-of-the-art equipment which includes

300 ampoules / min ampoule filling line

Line is equipped to produce ampoules of 0.5 ml to 10 ml

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steri le dosage forms100% commitment to

AUTOMATIC LEAK TEST & INSPECTION FACILITY

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A unique and core benefit from Global Pharmatech

Global Pharmatech has a state-of-the-art modern machine to conduct automatic leak test and inspection of both vials

and ampoules in our EU GMP compliant facility. This machine ensures high quality standards, which Global Pharmatech

employs to ensure that the final product is devoid of any aberrations.

A special feature of the ampoule filling line is the High Voltage Leak Detection Tester. Procured from Nikka Densok, Japan, this

pinhole inspector can perform non-destructive seal integrity testing for each glass container without any secondary contamination

of the product. It can detect upto 0.5 micron size pinholes, even in areas of the container surface where the product is not in

contact with the surface.

MANUFACTURING FACILITIES

Our manufacturing plant has been designed to meet the stringent

cleanliness and hygiene standards of pharma industry.

Nikka Densok Pin Hole Inspector

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Smooth surface of walls and floor to Filling is under Grade “A” area having

facilitate thorough cleaning and dust continuous particle monitoring with

free environment. a background of grade “B”.

Designated areas for different status Terminal Sterilisation

of materials to provide proper Our manufacturing services

segregation, preventing mix-up. include terminal sterilisation for

finished dosage forms.Regular and strict monitoring to

ensure that the required conditions Metone Sequential Particle Counters

are maintained consistently. They are installed for monitoring

non-viable particles during aseptic All men and material entries are

filling to meet requirements ofindependent of each other.

Class A Area.

Manufacturing is in Grade “C” area

and all vessels have chilling, heating

and sterilising facility to facilitate

manufacturing process.

Material transfers through dynamic

pass boxes between different

classified areas.

striving for continuous improvement in quality standards


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QUALITY ASSURANCE

In keeping with the requirements of Global Pharmatech is well equipped

our customers, our quality assurance with a Chemistry Laboratory as well as

department adopts the best of Microbiology Laboratory with well

procedures and practices and offers qualified technical staff. The Chemistry

value added services including: laboratory houses state-of-the-art and

latest instruments spread over 2000 sq Analytical method development and

mts which helps sampling, testing and validation

release of incoming materials, Process standardization, scale-up and intermediates and final product samples validation supportapart from conducting analysis of utility

In-house stability monitoring as per samples like Steam, Water, Nitrogen

ICH guidelinesand Compressed Air.

Regulatory & Dossier support

Product TransfersWalk-in stability chambersWe offer full service product

The entire Quality Operations management solutions. Over the years, Department is broadly divided into 4 we have built an exceptionally functions and each function is operated experienced transfer team and a robust by an independent team: transfer process which includes:

Quality Control Analytical method validation and

Quality Assurance technology transfers

Regulatory Services Speciality packaging design

Formulation & Development Regulatory project services and license

procurements

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Our strength is providing comprehensive services and products of the highest

quality and the best yield standards. This is possible due to our uncompromis-

ing approach and adherence to strictest of quality control procedures and

practices.


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The Purified Water System is the lifeline of a facility manufacturing sterile injectables. We have a PLC controlled process and

distribution of PW and WFI with the highest quality standards.

The purified water system is a state-of-the-art plant from Christ Nishotech, with continuous circulation loops, which produce 5000

litres of purified water per hour. The Christ Nishotech system is designed to confirm to cGMP, GEP & GAMP requirements and

delivers PW as per Pharmacopeia standards. This PW generation plant with continuous circulation loop produces 1500 litres / hour.

The purified water is free from physical, chemical & microbial (mainly pathogens and endotoxin) impurities.

PURE WATER & WATER FOR INJECTION GENERATION SYSTEM ENGINEERING FACILITY

Our engineering standards are at par with the best anywhere in the world. Our top-notch engineering team works round the clock to keep the pulse of

Global Pharmatech ticking. Our endeavour is to provide the best solution to rest of the departments, especially the Production team so that as a team

we set new standards of productivity, energy conservation and saving and overall enhancement of efficiency of our operations.

State-of-the-art HVAC system ETP & STP Nitrogen Plant 100% power backup through captive

Dedicated Air Handling Units produce Efficient effluent water treatment and In-house Nitrogen plant which meets power generation

clean air for each clean area and all sewage treatment plant with “ZERO” the required purity standards (Pressure Adequate power generation is available

operations. discharge facility. Swing Adsorption Technology). to ensure an uninterrupted supply of

power to meet the production need.

Global Pharmatech is equipped with the following utilities to support the Quality and Production Departments round the clock:


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Global Pharmatech is equipped with

High speed labelling machines for ampoules / vials with dedicated conveyors ensure through output.

Blister packing capacity of 3.00 lakh ampoules / day.

Online batch coding for cartons.

Rondo packing machine.

Large warehouse with a multi-tier stacking system both for raw materials, packing materials as well as finished goods.

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PACKAGING & WAREHOUSING FACILITY

The range of operations under this key department in Global Pharmatech include:

Ÿ Supply Chain Management

Ÿ Manufacturing planning and scheduling

Ÿ Vendor identification and evaluation

Ÿ Global sourcing

Ÿ Co-ordinating with QC & QA for cGMP compliance

Ÿ Management of finished goods

Ÿ Ensuring statutory compliances

We employ the latest techniques for commercial, planning, purchasing,

procurement, supply chain and stores management that are supported by

a robust ERP. This department of Global Pharmatech helps our customers

to get the highest quality product at the most viable cost.

Our focus is to meet the customers' needs through planning, procurement,

receipt, storage and issue of materials for manufacturing and shipping of

finished products on time. This helps our customers achieve their business

goals. We have been instrumental many an instance in helping our

customers launch their new products successfully.

Packaging and Warehousing is given the highest importance in Global Pharamatech. Both these departments play a

key role in meeting the special needs of our customers.

COMMERCIAL & LOGISTICS

customer service orientation is given topmost priority


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Training is an integral part of our operations and includes the following:

Identification of training needs

Induction and on-the-job training

Class room & external faculty training

Feedback and evaluation

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Our aim is to keep the workforce motivated and trained to perform at maximum efficiency

which ensures the dedication and commitment of each employee of Global Pharmatech to

each single project. This has a huge impact on the company’s operations.

HUMAN RESOURCES

Our commitment to managing our operations in a socially and environmentally responsible manner is very high.

Every single measure is taken to assure the health and safety of our employees, in compliance with all applicable

local, national and international legislations. Continuous work also goes on to minimize our environmental footprint.

In order to achieve HSE excellence in this area of our operations, we

A CARING ORGANISATION

100% commitment to Health, Safety & Environment

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Maintain safe and environmentally Continuously improve our HSE Schedule annual medical examination

sound operations by integrating HSE performance through a for all employees.

considerations into all activities. comprehensive HSE policy. Conduct vision test for inspection

Contribute to protect the natural and Conduct regular safety programs - personnel twice a year.

workplace environment. Work Safety, First Aid &

Fire Fighting etc.


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Our facility is always open for inspection by Regulatory & Customer Audit teams. Global Pharmatech has

been audited by international inspectors of our multinational partners and National Drug Authorities of

various countries.

In recognition of our commitment to quality standards, we have received the following certifications:

ACCREDITATIONS AND CERTIFICATIONSA FEW ENVIRONMENTAL INITIATIVES

The Green Energy Project of Global Pharmatech has recently gained momentum. This project is clearly aimed at using alternative modes of energy to run various facilities of

the plant thus contributing to Green Energy. In a small way, Global Pharmatech is doing its bit to save the environment.

Briquette Boiler

We have been successfully able to replace use of

fossil fuels in our operations by agricultural waste

based briquettes in the boiler for steam production

resulting into reduction of carbon footprint.

Zero Discharge ETP (Effluent Treatment Plant)

Treated effluent water is used for cooling towers,

boiler, washing and flushing.

Vapour Absorption Machine

CFC Free - Ozone friendly, Energy Saving –

Operations not dependent on electricity....which is

Green Energy.


National Organisation for Medicines,

Division of Production & Distribution

Control, Greece (EU-GMP Certificate)WHO GMP Certificate ISO 9001 Certificate

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The philosophy guiding our Corporate Global Pharmatech Pvt. Ltd. Global Pharmatech works with

Social Responsibility has been: Going participates in a wide range of committed grassroot organizations.

beyond pharmaceuticals..because programs that improve the well-being Our carefully chosen community

of the community and continuously support programs and partnerships we care.

strives towards changing the lives of benefit a wide cross-section of society.Therefore, at Global Pharmatech Private

the less fortunate. In addition, we also Ltd., giving back to the community is

respond with aid and support in times core to the organization. While

of crisis.business, profit and a healthy balance

sheet are crucial, the company strives

to create and maintain a strong sense

of social responsibility.

Our range of activities span tree

planting, medical support to the

needy and supporting orphanages

and NGO's.

A RESPONSIBLE CORPORATE

Our business objectives are designed to meet the dynamic needs of our valued customers. The resources of technical knowledge, state of the art

equipments and materials work in harmony to provide consistent delivery of quality products. Contract manufacturing business model of our organisation

instills confidence in our customers' mind of complete transparency, protection to their physical and intellectual property through established ethical

business practices.

OUR VALUED CLIENTS

Serving them is our inspiration

Global Pharmatech's operations utilize the best practices in the industry, and supported by state-of-the-art equipment and

laboratory.

Since our inception in 1995, we have grown to partner top pharmaceutical companies in India and abroad for manufacturing

their liquid sterile injectable requirements. Some of our esteemed and valuable customers are:


ANGLO-FRENCH DRUGS & INDUSTRIES LTD.

VALUES WE CHERISH AS A CORPORATE

At Global Pharmatech Pvt. Ltd., we share a strong set of values that serve as the foundation for our individual and team performance. Upheld daily by

each one of us in the team, through our involvement, actions and initiatives, we are working for what really matters — better health for patients and

value for each of our business clients.

The key values that we cherish and which drive everyday action

at Global Pharmatech are:

• PERFORMANCE WITH INTEGRITY • TEAMWORK & PARTNERSHIP

• COMMITMENT TO GOALS • INNOVATION

- Team GLOBAL PHARMATECH

All of us are faced everyday with the unique challenge to achieve new goals, to solve new

problems and develop new methods to improve efficiency. The determination to scale new

heights of excellence and passion to achieve and surpass our targets should never diminish.

In order to stay abreast of this dynamic world around us, we need to evolve, we need to

strengthen ourselves and we need to forge new partnerships. This should enable both us and

our customers to come out with simple and practical solutions, the foundation of which should

come from technical superiority and respect for each others views.

Our vision and mission is to be in the forefront of the emerging challenges of today's modern

healthcare and add value to our customers. This keeps us all in Global Pharmatech inspired

every day.

Therefore, please do contact us the next time you are looking for a reliable partner to

formulate and manufacture your sterile liquid preparations.

We promise you that we'll bring quality, excellence, skills, strength, stability, latest technology

and value for money to make your project a success.

Trust us and try us out….we assure you…..you will not be disappointed.

Documents

SPECIALIZED IN LIQUID STERILES - Global …...High speed labelling machines for ampoules / vials with dedicated conveyors ensure through output. Blister packing capacity of 3.00 lakh