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Sterile & Non-sterile Oncology & High Potent Manufacturing
Our facility is a globally recognized manufacturer of injectable and solid oral dosage (OSD) oncology products, approved by the US FDA and EU GMP regulatory authorities.
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- Our Capabilities
- Manufacturing
Sterile & Non-sterile Oncology & High Potent Manufacturing
Our facility is a globally recognized manufacturer of injectable and solid oral dosage (OSD) oncology products, approved by the US FDA and EU GMP regulatory authorities.
We adhere to stringent international regulatory standards. Utilizing advanced isolator technology and Closed Restricted Access Barrier System (cRABS), our manufacturing processes ensure optimal containment and sterility assurance for oncology products and other potent molecules. Our state-of-the-art facility is equipped to handle both injectable and OSD formulations, capable of accommodating larger batch sizes to meet diverse market demands.
Our decades of experience and proven competence in sterile/injectable and non-sterile manufacturing set us apart.
We operate a USFDA and EU GMP-approved, state-of-the-art oncology facility specializing in liquid and lyophilized injectable formulations, as well as oral solid dosage forms.
Our oncology manufacturing facility is equipped with high-quality standard equipment and infrastructure, differentiating us from others. Key equipment includes the BOSCH Filling Line, Martin Christ Lyophilizer with ALUS, Fedegari Autoclaves, and GEA Granulation Line.
Injectable Manufacturing
Fully automated & Integrated BOSCH Line for high degree of sterility assurance
- Clean Rooms & Aseptic areas are built with GRP (Glass Reinforced Polyester) Panel.
- Integrated Bosch Filling & Sealing Line (120 Vials /Min) with IPC System & External Vial washing system under cRABS.
- Martin Christ Lyophilizer (10.02 Sq.m) with pizza door, integrated with Auto-loading & Unloading system under cRABS
- Fedegari Steam sterilizer (1060L) for moist Heat sterilization of change parts and other loads.
- Propack Manufacturing vessels with Automatic CIP, SIP & Product Transfer system & Controlled by SCADA System
Orals Solid Dosage Form Manufacturing
Oral solid dosage form manufacturing refers to the production process involved in the creation of pharmaceutical products that are administered orally in a solid form, such as tablets, capsules, and powders. It is a crucial aspect of the pharmaceutical industry, as oral solid dosage forms are one of the most common and convenient ways to deliver medications to patients.
Integrated Fully Contained GEA OSD Manufacturing with Isolator Technology
Self contained GEA integrated granulation line to comply OEB 4 for handling cytotoxic molecules having processing capacity from 4.50 kg to 36.00 kg by changing the High sheer mixer granulator bowl from 30 ltrs to 90 ltrs. Machine is designed to perform wash in place for cleaning.
Compression Machine
21 station self contained compression machine specially designed to handle cytotoxic molecules.
| Infrastructure | Make | Capacity |
|---|---|---|
| Injectable Section | ||
| Compounding & Filtration Vessel | Propac | 50L, 200L and 1000L |
| Integrated Vial Filling Line | BOSCH | 120 Vials per min |
| Lyophilizer | Martin Christ | 10 sq mts |
| Autoclave | Fedegari | 1075 lts |
| OSD Section | ||
| Integrated Granulation Line | GEA | 30L, 90L, 600L |
| Integrated Single Pot Processor | BOSCH | 75L |
| Bin Blender | GEA | 30L, 60L, 100L, 1200L |
| Compression Machine | GEA | 21 station/ 60 RPM/ 75600 tablets/hr |
| Capsule Filling Machine | MG2 | 70000 Capsules/hr |
| Coating Machine | LB BOHLE | 4 pans - 10L, 25L, 50L, 350L |
| Dosage Form | Capacity Per Annum |
|---|---|
| Tablets | 150 million |
| Capsules | 150 million |
| Injections | Liquid 10 million |
| Lyophilised 2 million |
Designed and operated to meet regulatory standards
Quality in Every Unit
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