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Acme Generics LLP
(Oral Solid Dosage Facility)

Overview

 
  • Facility area: 13172 sq. meter
  • Commercial manufacturing area : 18315 sq. meter
  • Available Dosages : Tablets & Capsules
  • Approval : USA Approved for FDA 21 CFR compliance for manufacturing OTC & Dietary Supplements
  • ANVISA, EU-GMP scheduled

Acme Generics LLP is a newly constructed facility, situated at Village Davni, Baddi, Distt. Solan (H.P) and about 60 km from Chandigarh Airport.

The factory is situated in an open space with adequate green area surrounding the building. The environment is clean and is without polluting industry nearby.

Site Exterior

The plot size of factory is 13172 sq. meter with 18315 sq. meter constructed area.
The facility consists of General Block, Hormone Block, Utility Block, ETP, Scarp Yard, Solvent Yard, High Speed Diesel (HSD) Storage and Security Block.

Major Machines & Capabilities

 

In the Production area, all the equipment having contact parts with the product, in manufacturing, are made of SS 316L. Equipments have been designed with ease of cleaning in mind in each area of the production. Most of the critical equipments like Rapid Mixer Granulator, Fluid Bed Driers, Octagonal Blender, Compression Machines with AWC, Automatic Coating Machines, Automatic Capsule Filling Machines, Blister Packing Machines with visual inspection system & Strip Packing Machines with NFD are PLC controlled.

Compression Area

It has installed various Tablet Compression Machines:


  • One Compression machine 31 D with capacity 223220 to 139500 tab/hr
  • One Compression machine 37 B with capacity 26640 to 166500 tab/hr
  • One Compression machine 45 station, B tooling with capacity 324000/81000 max/min.
  • 2 Compression machines 51 station, D tooling with capacity 490000/91800 max/min
  • 2 Compression machines 65 station, B tooling with capacity 1,17,000/6,24,00 max/min

Twelve number of Deduster cum Metal Detectors (Make Unique Equipment) with capacity 9999 tab/min are equipped with compression machines.

Coating

Coating Machines of different sizes are also equipped along with other allied equipments.


  • One Coating pan of 60 inches with capacity of 300 Kgs
  • 2 Coating pan of 48 inches with capacity of 140 Kgs
  • One Coating pan of 36/24 inches with capacity of 18-55 Kgs

Capsule Filling

Fully Automatic Capsule Filling Machine AF-90 T (Make PAM) is also equipped with capacity of 90000 capsules/hour.

Coating Machines of different sizes are also equipped along with other allied equipments.


  • One Coating pan of 60 inches with capacity of 300 Kgs
  • 2 Coating pan of 48 inches with capacity of 140 Kgs
  • One Coating pan of 36/24 inches with capacity of 18-55 Kgs

The judicious selection and orientation of equipments and machinery are capable of offering exhaustive range of oral solid dosage forms i.e. tablets (of any shape, size and types) and filled hard gelatin capsules (of various size).

Packing

 

It also has ten packing lines consisting of 7 Blister packing machines and two Strip packing machine.

Quality Control
(Equipments and Instruments)

 

In Quality Control Laboratory, the major instruments like 06 HPLCs (server) Make Shimadzu/Prominence, One UV/Visible Spectrophotometer Make Agilent, 02 GC Make Agilent/Agilent Cary-630, TOC analyzer, FTIR, Karl Fisher Titrator, Autoclave, UV Cabinets etc. are computer software controlled complying to 21 CFR Part 11.
Microbiology section has dedicated facility for microbial testing having critical equipments/instruments like Double door HPHV Steam Sterilizer, Incubators, LAF, Bio-safety Cabinets etc.

Stability Section has 04 Walk-in Stability Chambers (for accelerated, intermediate, long term and stand by) Make THERMOLAB for storage conditions/country specific requirement for conducting stability studies. 

Procurement and Storage

 

Raw/Packing materials are procured only from vendors adhering to stringent quality standards. Evaluation of vendor statistics is updated on a regular interval ensuring quality control over receivables. Materials received are subjected to rigorous quality checks and are then moved to a designated storage area for later consumption in production.