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.