VIRDEV Intermediates

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VIRDEV Intermediates

• A company committed for
• Technology excellence
• Customer satisfaction.

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INTRDOUCTION OF THE COMPANY
NAME OF THE COMPANY- M/S. VIRDEV Intermediates
PVT. LTD. Started in the year 1995. LOCATION AND
ADDRESS OF THE FACTORY AND OFFICES FACTORY
- Block No. 46/47, Plot No.2,
Moje Palsana, Tal. Palsana,
Dist. Surat. PIN CODE-394 315
GUJARAT INDIA Tel. No. -
91(2622) 264804 Fax No. - 91(2622)
264504. Email-
VIRDEV_at_VIRDEVgroup.com SURAT OFFICE -S.No. 33/1
A, Plot No. 1,
Behind Sub-Jail, Khatodara,
Surat. 395002. GUJARAT
INDIA Tel. No. - 91(261) 2635971,
2635972 Fax. No. - 91(261)
2635973. MUMBAI OFFICE -108/109 DALAMAL
CHAMBERS, NEW MARINE
LINES,MUMBAI 400 020. INDIA. PHONE
No.- 91(22) 56372777, 56985337, 56385338
FAX No. - 91(22) 56385339
Email- VIRDEV_at_VIRDEVgroup.com
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CONSTITUTION OF THE FIRM - PRIVATE
LIMITED.NAME OF THE DIRECTORS.SR.NO
NAME
POSITION(1) MR. DHARMESH
M.SHAH
CHAIRMAN(2) MR. NARENDRA
B.JARIWALA
MANAGING DIRECTOR(3) MR. SANJAY A.
SOLANKI
FINANCE DIRECTOR(4) MR. KAUSHIK B.
JARIWALA DIRECTOR(5)
MR. VIRAL N. JARIWALA
WORKS DIRECTOR
BOARD OF DIRECTORS MANAGEMENT STRUCTURE
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In the initial stages of year 1995
VIRDEV had started its production with products
like (1)MEFENAMIC ACID B.P.(2)PIROXICAM
U.S.P.(3)METFORMIN HCL. I.P.For product
MEFENAMIC ACID B.P. VIRDEV had faced vendor
quality audit from M/S. WARNER LAMBERT U.S.A.
WARNER LAMBERT had APPROVED plant facility
approved the product quality of MEFENAMIC ACID
B.P for their Export in all Asian Countries.
Also BLUE CROSS LABORATORIES had conducted
vendor quality audit for MEFENAMIC ACID B.P
had approved plant facility product quality for
their consumption.For PIROXICAM U.S.P. VIRDEV
had faced vendor quality audit from M/S. PFIZER
LTD M/S. IPCA LTD. They had approved plant
facility product quality of PIROXICAM USP for
their consumption.Also VIRDEV had manufactured
anti-viral drug ZIDOVUDINE B.P. which was mainly
exported.Then after VIRDEV had diversified its
concentration on new drug molecules like, (1)
ALENDRONATE SODIUM(2) MELOXICAM (3) CELECOXIB
(4) ROFECOXIB (5) CETRIZINE DIHYDROCHLORIDE(6)
CITALOPRAM HBr. (7) ESCITALOPRAM OXALATE(8)
VALDECOXIB(9) PARECOXIB SODIUM
(10)ETORICOXIB.(11)TIZANIDINE
HYDROCHLORIDE(12)ARIPIPRAZOLEIn near future
VIRDEV is projecting for constructing the plant
facility to comply as per US FDA norms schedule
M, for four different products and its
construction work has already started.VIRDEV has
fully equipped in house R D center to work for
regulatory market and non-infringing process for
the patented drugs.
PRODUCT PROFILE OF THE ORGANIZATION
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1. CETRIZINE DIHYDROCHLORIDE2. PIROXICAM3.
MELOXICAM4. CELECOXIB5. ROFECOXIB6.
VALDECOXIB7. PARECOXIB SODIUM8. ETORICOXIB9.
AZIDO THYMIDINE (ZIDOVUDINE)10. ALENDRONATE
SODIUM11. TIZANIDINE HCl12. CITALOPRAM HBr13.
ESCITALOPRAM OXALATE14. DESLORATIDINE15.
GATIFLOXACIN
PRODUCT PROFILE
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WARNER-LAMBERT INDIA LTD. PFIZER INDIA LTD.
CIPLA LIMITED INDIA. CADILA HEALTH CARE.
CADILA PHARMA. SUN PHARMA. TORRENT PHARMA.
GLENMARK PHRMACEUTICALS. DR. REDDYS
LABORATORIES. LUPIN LABORATORIES. UNICHEM
LABORATORIES. IPCA LABORATORIES. WOCKHARDT
LTD. LYKA LABORATORIES LTD. KOPRAN EMCURE
PHARMA. UMEDICA LABORATORIES. MEPRO
PHARMACEUTICALS. H.D.V CHEM PHARM LTD.
BLUECROSS LABORATORIES INDIA.
CUSTOMER BASE LIST OF PRIME CUSTOMERS
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QUALITY POLICY

• We are committed to manufacture highest quality
  active pharmaceutical ingredients and their
  Intermediates as per customer and applicable
  pharmacopoeia requirements. Our aim is to meet
  and exceed the requirements of customers.
• This shall be achieved by
• Following current good manufacturing practices
• Due respect to the applicable regulations
• Focus on training and competence development
• Implementation of good laboratory practices
• Constant innovation and research and development
• Improvement in the product, process and systems
• Team work
• Support to the vendors and inputs from customers
  for continual improvement.
• NARENDRA B. JARIWALA
• MANAGING DIRECTOR.

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MEASURES FOR PREVENTION AND CONTROL OF
ENVIRONMENTAL POLLUTION. VIRDEV Intermediates
Pvt. Ltd. have established a full fledged water
waste effluent treatment plant consisting of
primary, secondary and tertiary treatment units
and have been operating the same round the clock.
The treated effluent is utilized on land for
gardening, plantation and irrigation within the
premises of the industry only.The high COD
waste effluent is send to liquid solid waste
incinerator which is owned by us within our
premises for captive purpose of Incineration of
liquid effluent.
ENVIRONMENT, HEALTH AND SAFETY COMMITMENT
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MEASURES FOR PREVENTION AND CONTROL OF
ENVIRONMENTAL POLLUTION. Incinerator is
provided with wet cyclone separator and 30 mtr
High stack / vent attached to it for proper
dispersion of pollutants emission from stack /
vent.Air pollution control equipment like water
scrubber are installed with stack attachment for
proper dispersion and are operated at their full
efficiency stack monitoring for process emissions
is done on regular basis.The solid waste
generated is dried on drying bed and packed in
LDPE bags for storing area with impervious
flooring and bound wall. Leachete collection
system is provided, which is connected to E.T.P.
In-let. The sludge is sent to GPCB approved TSDF
site of M/S Gujarat Enviro Protection
Infrastructure Limited. (GEPIL)Efficient
scrubbing facility is also provided in
manufacturing plant to control air pollution.
ENVIRONMENT, HEALTH AND SAFETY COMMITMENT
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We at VIRDEV Intermediates Pvt. Ltd.
Palsana, Surat are engaged in manufacturing
various chemicals as an input for different
industries.gt We are committed to maintain and
continually improve the Occupational Health,
Safety and Environmental (HSE) performance at our
plant. gt We shall have proactive management
system for reviewing periodically various
objectives and targets related to HSE.gt We
shall ensure that Health, Safety and Environment
is integrated in all management decisions.gt We
shall comply with all applicable Legal and
Regulatory requirement prescribed under various
Acts and Rules.gt We shall train and strengthen
awareness among all employees while seeking their
active co-operation on HSE related matters.gt
We shall conserve resources in particular water,
power, oil and minimize or substitute use of
hazardous materials.gt We shall communicate HSE
Policy to all employees and make it available at
prominent places in the plant and interested
parties concerned. NARENDRA B.
JARIWALAMANAGING DIRECTOR
ENVIRONMENT, HEALTH AND SAFETY POLICY
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gt VIRDEV has appointed DR.B.G.DODIA
(M.B.B.S., CIH) Sr. Industrial Health consultant
he is rendering Medical Services at VIRDEV
Intermediates PVT. LTD. PALS ANA. He is coming
regularly for Health checking of all
employees.gt We are carrying our Pre-medical
Periodical medical check up for each employee
regularly. gt We are maintaining Health
Register form No. 32 33.gt Blood Examination-
Routine Cholesterol Sugar ,Blood Grouping are
done once in year.gt Suitable medicine
Antidotes and injections are always available for
any emergency.gt In case of emergencies,
SANJEEVANI HOSPITAL at CHALTHAN nearby
KADODARA, SURAT is our authorized hospital, which
is located within 8 to 10 kilometers, distance
from the factory where medical facility are
available for 24 hours to handle any emergency.
gt All employees are strictly advised to use
all Personnel Protective Equipment to avoid
obnoxious diseases.gt First Aid Training is
conducted by companys Doctor twice in a year.
Trained staff are always available in each shift
for giving First Aid treatment or to handle
any emergency.
PERSONNEL HYGIENE AND HEALTH
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PERSONNEL HYGIENE AND HEALTH

• Annual medical check up of all employees
• Periodical medical check up of contractors
  personnel.
• Gowning for all personnel determined and provided
• Gowning management is done.
• Employees checked for nails hairs and
  communicable diseases and such employees are
  prevented for any entry in the manufacturing
  areas.
• Washing facilities provided.
• Entry exit procedures designed and shall be
  implemented in the proposed facilities
• Health and hygiene accorded top most priority.

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VIRDEV Intermediates Pvt. Ltd. has maintained
effectively safe environment for working.VIRDEV
Intermediates Pvt. Ltd. is equipped with all
equipments complying as per the norms of the
mandatory requirements. All electrical fittings
fixtures are flame proof. Proper earthing is
provided at all reactors, storage tanks,
centrifuges, filters etc. for safety against
static electricity generation. All required
personnel protective equipments are kept
available where ever required for the safety
against toxic hazardous chemicals.Safety
training is regularly given to all
employees.Adequate numbers of DCP type Fire
extinguishers CO2 type fire extinguishers are
made readily available at every concerned area
for any emergency.First Aid facility is kept
available for all primary treatment.
SAFETY COMMITMENT AND MEASURES TAKEN
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TRAINING, AWARENESS AND COMPETENCE

• IDENTIFICATION OF TRAINING NEEDS
• SKILL AND COMPETENCE MATRIX OF PERSONNEL
• TRAINING PLAN
• TRAINING SCHEDULE
• PROVIDING TRAINING
• ESTABLISHMENT OF COMPETENCE OF THE PERSONNEL
• REGULAR TRAINING
• TRAINING IN CGMP GLP GOOD ENGINEERING
  PRACTICES SAFETY HEALTH AND ENVIRONMENT,
  SAMPLING TESTING OF THE MATERIALS PROCESS
  CONTROLS CHANGE CONTROLS FAILURE
  INVESTIGATIONS ETC.

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VIRDEV Intermediates Pvt. Ltd. have designed
working strategy for all areas.VIRDEV
Intermediates Pvt. Ltd. is emphasizing more on
giving training to all of its employees to make
them familiar with their working area, quality of
work, to maintain Environmental, Health Safety
requirement in their working area, to follow cGMP
in their working area.More training will
increase skill competency in employee to
maintain high standard of quality requirement in
each working area.
WORKING TECHNIQUES AT VIRDEV
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ENGINEERING MANAGEMENT

• PREVENTIVE MAINETENANCE PLAN AND ITS COMPLIANCE
• PREVENTIVE MAINTENANCE PROCEDURES
• PREVENTIVE MAINTENANCE CHECKLISTS
• HISTORY CARD OF THE EQUIPMENTS
• VALIDATION OF THE EQUIPMENTS
• REGULATORY COMPLIANCE OF THE STORAGE TANKS
  BOILERS AND OTHER APPLICABLE EQUIPMENTS.
• IDENTIFICATION OF EQUIPMENTS AND PIPELINES
• PROCEDURES FOR THE OPERATION OF THE EQUIPMENTS
• BREAKDOWN MAINTENANCE IS ATTENDED PROMPTLY
• PROCEDURE AVAILABLE FOR OPERATION AND MAINTENANCE
  OF ALL EQUIPMENTS.

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PREVENTIVE MAINTENANCE AT VIRDEVAs preventive
maintenance is a prime key factor to avoid
any type of forced or emergency break down
continue with smooth working environment
maintaining high quality standard.VIRDEV has
planned preventive maintenance schedule for all
equipments to make them working effectively to
maintain high standard of quality to full-fill
the timely requirements of customers.
ENGINEERING MANAGEMENT
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ENGINEERING MANAGEMENT
? LIST OF EQUIPMENTS IN MAIN PLANT
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ENGINEERING MANAGEMENT
? LIST OF EQUIPMENTS IN MAIN PLANT
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ENGINEERING MANAGEMENT
? LIST OF EQUIPMENTS IN SOLVENT RECOVERY PLANT
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ENGINEERING MANAGEMENT
UTILITIES -
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STORAGE TANKS -(1) M.S.tank- 5 NOS. for storage
of solvents in Bulk quantity.
(2) 3 tones capacity,
cryogenic storage tank for liquid Nitrogen
storage --
BOC make . SUMMARY OF REACTORS -
S.S. REACTORS 25
NOS. G.L.REACTORS 7 NOS. HDPE
REACTOR 1 NOS. DRYER
8 NOS. CENTRIFUGE
7 NOS. SPARKLER FILTERS 4
NOS. REBOILER 1 NOS.
ENGINEERING MANAGEMENT
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INSPECTION, MEASURING AND TEST EQUIPMENT AND
INSTRUMENT MANAGEMENT

• REQUIRMENTS OF ISO 10012-1 AND 10012-2 for
  calibration management followed.
• LIST OF INSPECTION, MEASURING AND TEST EQUIPMENTS
  UPDATED.
• CALIBRATION PLAN AVAILABLE.
• CALIBRATION DONE ON DETERMINED FREQUENCIES
• CALIBRATION TRACEABLE TO INTERNATIONAL STANDARDS
  TRACEABLITY ESTABLISHED.
• HISTORY CARDS OF THE INSPECTION, MEASURING AND
  TEST EQUIPMENTS MAINTAINED.
• VALIDATION OF THE INSPECTION, MEASURING AND TEST
  EQUIPMENTS ENSURED.

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? LIST OF INSTRUMENTS IN LABORATORY
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01. ACYL FRIEDAL-CRAFT REACTION.02.
OXIDATION03. BROMINATION04. CYCLISATION05.
HYDROLYSIS06. CONDENSATION 07. CRYOGENIC
REACTION at -70C to 80C08. AMINATION09.
GRIGNARD REACTION10. SULPHONYL CHLORINATION11.
METHYLATION12. REDUCTION13. NITRATION14.
ACETYLATION
15. HYDRO BROMINATION16. HYDRO CHLORINATION17.
N-BUTYL LITHIUM REACTION18. Na-METAL
REACTION19. POTASSIUM TERTIARY BUTOXIDE
REACTION.20. AMMONIA PRESSURE REACTION MAXIMUM
UP TO 6 Kg/cm221.DIAZOTISATION.22.HYDROGENATION
23. CYANATION
CHEMICAL REACTIONS MANAGEMENT A LIST OF
CRITICAL REACTIONS
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WAREHOUSE MANAGEMENT

• SEPARATE BUILDING FOR STORAGE OF RAW MATERIALS
  PROVIDED.
• SEPARATE BUILDING FOR STORAGE OF FINISHED GOODS
  PROVIDED.
• REQUIREMENTS OF ENVIRONMENT, HEALTH AND SAFETY
  ENSURED WHILE HANDLING OF RAW MATERIALS.
• ENTRY AND EXIT PROCEDURES FOR PERSONNEL IN THE
  WAREHOUSE UNDER DOCUMENTATION AND IMPLEMENTATION
• SOLVENT TANK FARM WITH APPROVED CERTIFICATON FROM
  COMPETENT GOVERNMENT AUTHORITIES.
• REJECTED RAW MATERAILS ARE RETURNED TO THE
  SUPPLIERS.
• ONLY APPROVED RAW MATERAILS ARE USED.

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WAREHOUSE MANAGEMENT

• PERIODIC TESTING/ RE- TESTING OF RAW MATERIALS IS
  DONE BY THE QUALITY CONTROL.
• RAW MATERIALS AND OTHER ITEMS IDENTIFIED BY
  LABELLING AS UNDER TEST SAMPLED PASSED
  APPROVED REJECTED.
• BATCH WISE MATERIALS ARE ISSUED.
• MATERIALS ARE PROTECTED FROM CONTAMINATION
  RAINS AND OTHER SOURCES WHICH CAN IMPACT THEIR
  QUALITY.
• REQUIRED MATERIALS ARE KEPT UNDER AIR
  CONDITIONING STORAGE( PROPOSED )

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QUALITY CONTROL AND QUALITY ASSURANCE

• A SEPARATE DEPARTMENT QUALITY CONTROL AND QUALITY
  ASSURACE PROVIDED. IT IS HEADED BY THE
  HOD-QUALITY ASSURANCE/ QUALITY CONTROL.
• APPROVED SPECIFICATIONS ARE USED FOR PURCHASE OF
  RAW MATERIALS SAMPLING AND TESTING.
• PROTOCOLS ARE USED FOR TESTING OF THE MATERIALS.
• CALIBRATED INSTRUMENTS ARE USED.
• WHEN ALL TESTS HAVE BEEN CONDUCTED THEN ONLY
  FINISHED API / Intermediates ARE RELEASED FOR
  DISPATCH TO THE CUSTOMERS.
• QUALITY OF FINISHED PRODUCTS IS PROTECTED BY
  SUITABLE PRIMARY AND SECONDARY PACKAGING.
• REGULATORY COMPLIANCE AS ESTABLISHED BY
  IP/BP/USP/ EP AND OTHERS ALWAYS COMPLIED.
• FINISHED PRODUCTS ARE PROPERLY LABELLED AND
  LABELS ARE UNDER THE CONTROL OF THE QUALITY
  CONTROL.

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Our Quality Performance
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Our Quality Performance
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Our Quality Performance
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Our Quality Performance
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Financial Performance( in Lakhs of Rupees)
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Financial Performance( in Lakhs of Rupees)
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Financial Performance( in Lakhs of Rupees)
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Financial Performance 2000-01 TO 2004-2005
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TURNOVER PERFORMANCE YEAR 2000-01 TO 2004-05
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Relationship between Turnover and Net Profit