Theon Pharmaceuticals Limited

Production Block A – General Oral Solid Dosage forms namely Tablets and Capsules: It has Installed Semi Automatic Capsule Filling and Polishing Machine, Tablet Compression Machine of Cadmach and Cip, a bi-layered compression machine of Cadmach, along with the other allied equipment. It also has three packing lines consisting of 2 Blister Machines of Elmach, 2 Alu-Alu machines of Precision Gears and satellite Strip Machine of Satellite Engineers. Fully automated 48 inches coating pan of Prism Pharma apart from a manual 36 inches coating pan of Anchor Mark also form its part. The Judicious selection and orientation of equipment 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) to select from.

Production Block B – Beta -Lactum Products (Pencillins) in Tablets and Capsules dosage form: Especially designed for critical RH products with Cold Storage rooms; specially dedicated for storing and dispensing of Potassium Clavulanate. Critical Environmental Condition is maintained in tablet manufacturing section. AHU''s operational conditions are always maintained to handle season variability. Capsules Filling Section is configured with equipment like high capacity Compactor, Blenders (Double cone and Octagonal) & fully automatic AF-40 T capsule filling machine.

Production Block C – Cephalosporins Oral Solid Dosage & Dry Syrups: Tablet Manufacturing Section with Double cone blender, Oven drier, 45 & 27 Stn Cadmach Compression M/c, 48" Auto Coater and stirrer constitute the array of equipment to produce coated and uncoated tablets. Packing Section is configured with two packing lines supported by Hi-speed Rapid Pack Alu-Alu and Satellite Strip packing machine. Versatile high speed dry syrup line consists of bottle decartoning system, vacuumised bottle cleaning machine, high speed powder, 24 funnel head bottle filling machine, 6 head plastic screw capping machine and induction sealing machine. We have change parts to fill and pack the dry syrups in HDPE (30 ml and 60 ml) and Glass bottles, Sticker labeling machine with on line ink jet printer machine offers aesthetic packing.

Production Block D – Dry Powder Injectables Beta - Lactum and Cephalosporin''s section: Fully automated, high speed, sophisticated Dry Powder Injectable lines.

Our  machinery which are certified by the State Drug Control Authority, to be in compliance with cGMP guidelines as specified under Schedule M of the Drugs and Cosmetic Act, 1940.

 

We have the facility to manufacture Tablets and Capsules (Both B lcatum and other then B lactum), using highly automated & modern machinery. Utmost attention is paid to hygiene of equipment and manufacturing areas. Also, the people involved in the manufacturing are ensured to be properly sanitized.

 

We have installed Fully Automatic Capsule Filling and Polishing Machine of Paam, tablet Compression Machine of Cadmach and Cip, RMG of Tapasya and FBD of Alliance along with the other allied equipment like, Multi Mill, Vibro Sifter, Tablet Coating Machine, Dust Extractor Machine, De-Burring and De-Dusting Machine, Paste Kettle etc.

 

All the Utilities' Equipment/plants have been procured from reputed suppliers like Purified water generation plant form Pentair Water India (a subsidiary of Pentair Inc. USA), Air compressor from Ingersoll Rand, 500 KVA Diesel generator from Sudhir Cummins and 750 KVA Transformer from Compton Greaves etc.

The various salient features of the facility are as follows:

Plant design is based on the vertical flow concept with two main floors

Ground Floor: Change rooms, ware houses, Laboratories etc.

First Floor: Complete process areas.

Separate service floors for both the above main floors, which are designed to locate complete HVAC equipment, light fitting, Electrical MCCs vacuum pumps etc. This will facilitate to keep the production area completely isolated and free from unwanted movement of maintenance personnel and to maintain the cleanliness in the production areas. HVAC system is installed in the process plant. It comprises separate AHUs for various areas and is provided with HEPA filters to achieve air classification at Class 1.0 lac.

• Dedicated ETP to treat the effluent generated from the plant. The treated water will be used for the plantation inside the factory area.

• Concealed drains from storm water and domestic effluent.

• Complete plant protection with adequate fire hydrant system.

• Automatic access control system, in order to ensure entry of authorized personnel only into the plant area.

• An adequate number of trees and green plants have been planted inside factory complex which ensures the pollution free environment around the factory.

• Purified water generation through Reverse Osmosis (RO membranes of GE water and process Technologies, USA) and a continuous purified water loop system with electro polished piping has been installed inside the process area.

• Back up Electrical power supply through a silent type DG with adequate capacity to operate the plant in case of any emergency or poser failures.

• A modular laboratory having all the latest, sophisticated instruments for carrying out in- house analysis.

• Separate buildings for installation for utilities equipment, Engineering workshop, Engineering stores etc.

Theon has always striven to be developing cost-effective and reliable formulation.
Our Dosage Development Laboratory conducts drug delivery research on a wide range of dosage forms including tablets, capsules, Dry syrup.

Capabilities:

• Development of novel, modified release Solid Oral dosage forms.
• Cost effective Test masking Technology
• Development of drugs with poor solubility to enhance solubility and bioavailability
• Design and development of pharmaceutical products of International standards.
• Pre formulation studies.
• Lab / pilot scale development and stability studies.
• Scale up for process optimization / validation.
• Technology transfer of new products.
• Technical assistance for manufacturing.
• Data management (for transfer to customer / Regulatory Affairs).
• Prototype Equipments as that of manufacturing facilities.

Function:

• Characterization of Reference drug product, Screening of Excipients & their selection.
• Development of new dosage forms.
• Development of Analytical Methods with help of latest Instruments in Lab.
• Stability study of development batches with various conditions as per ICH requirements.
• Support to regulatory department by submitting technical data of development study.
• Preparation of Tech Transfer documents & Validation protocols.
• Support to Manufacturing unit to conduct Scale up / Validation batches.
• Stability study of development batches with various conditions as per ICH requirements.
• Technical support to manufacturing unit as & when required.