Plant Infrastructure

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Manufacturing Area – Hormones/Steroids

Two separate dedicated manufacturing areas for hormones and steroids

  • Glass Line Reactor of 630 Lt capacity
  • SS Reactors ranging from 0.35 KL to 1.25 KL
  • Clean Room Area of Class 1,00,000
  • From gram to Kilo Level Capacity Manufacturing Area
  • ANFD (Agitated Nutsche Filter Dryer)
  • Air Mist Shower
  • HEPA Filters of 0.3 microns in Powder processing Area
  • Provision of BIBO (Bag in bag out) filters
  • Rota cone Vacuum Dryer
  • Large Rooms and Corridors for easy man and material movement
  • Mfg. area is designed, constructed, adapted, and maintained to suit the manufacturing operations so as to permit the production of drugs under hygienic conditions.
  • Dedicated Micronization Area with isolator system
  • Total 3 Clean Room Areas
  • Glass Assembly from 50 Lts. to 200 Lts. for Small Volume Products

Quality Control Laboratory

List of Major Instruments:

  • * HPLC System from Shimadzu
  • * GC with Head Space and Auto Sampler & PDA Detector
  • * UV Spectrophotometer
  • * FTIR
  • * Polarimeter
  • * Karl Fischer
  • * Micro Balance
  • * Potentiometer
  •   Biosafety Cabinet
  •   IR Moisture Balance
  •   Elga Water Purification system

( note: * All Equipment’s are 21 CFR Complaint)

List of Major Instruments in Microbiology Lab:

Fully Independent In-house Microbiology lab. with,

  •   BOD Incubator

  •   Bacteriological Incubator

  •   Laminar Air Flow

  •   Autoclave (*Horizontal & Vertical)

  • * TOC Analyzer (Shimadzu)

  •   Microscope
  •   Colony Counter

  •   Biosafety Cabinet

( note: * All Equipment’s are 21 CFR Complaint)

Effluent Treatment Plant (ETP)

  • Well Equipped ETP Plant with Primary, Secondary and Tertiary Treatment to achieve Latest Statutory Guidelines.
  • Multiple Effect Evaporator to treat high COD Effluent.
  • Kill pots provided to neutralize the drug potency with sodium hypochloride.
  • ETP Plant is well equipped to achieve Zero Liquid Discharge.

Quality Assurance and Environment

EHS Program

  • Ensuring Personnel Safety is of priority.
  • Effective Safety & EHS Training.
  • Personal Protective Equipment made available.
  • Effective Fire Hydrant System with Site-Emergency Plan
  • Situated less than 1 km away from the Government Hospital
  • 250 Kva Back-up Diesel Generator connected to all Key Equipment’s to ensure minimal downtime.

Quality Assurance

  • Validation Master Plan
  • Equipment qualification
  • Process validation
  • Cleaning validation
  • HVAC validation
  • Water system validation
  • Analytical validation
  • Change Control, Deviation, OOS Management
  • Effective GMP Training to all Employees
  • Periodic Internal Audits

Phone

(+91)-22-28780912

(+91)-22-28780892

Manufacturing Unit

Plot No K -2, M.I.D.C Tarapur, Dist. Palghar, Boisar 401506, Maharashtra, India

Marketing Office

10th Floor, 1004, Unique Towers, Off S V Road, Behind Patel Auto, Near Kamath Club, Goregaon West, Mumbai 400062.