Headquartered in Chennai, India, Accord Labs is a fast-growing generic pharmaceutical company with a major focus on development and manufacture of IP led niche finished dosage formulations and Active pharmaceutical ingredients (APIs) including cytotoxic, oncology, and nephrology formulations.
Accord Labs manufacturing facility has been constructed to the strictest specifications and in accordance with the principles of current Good Manufacturing Practices as required by the guidelines of the USFDA, UK-MHRA, PIC/S, TGA-Australia, Health Canada, ANVISA-Brazil, MCC-South Africa and other regulatory agencies across the globe.
Accord Labs provides world-class manufacturing facilities for sterile oncology products (Liquid and Lyophilized vials) and Oral solid dosage forms (Tablets and Capsules).
Cytotoxic products are among the most highly sophisticated and sensitive drugs to handle and produce. Utilizing Isolator technology and RABS (Restricted Access Barrier System) for commercial manufacturing helps AccordLabs to maintain a high degree of sterility assurance and containment while a product is being manufactured. In addition, this technology helps to maintain the integrity of the molecule, enhance product sterility and ensure the safety of the personnel.
MANUFACTURING OF CYTOTOXIC, ONCOLOGY, AND NEPHROLOGY FORMULATIONS.
Injectable Facilities Features
- 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 facilities features
- 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.
Laboratory
This facility is fully equipped with in-house capability to perform all the chemical, instrumentation and microbiological tests as per Pharmacopeia and applicable specifications.
Quality control Lab is equipped with all modern instruments like HPLCs, GCs, FTIR, UV-VIS spectrometer etc. for routine testing of Raw materials, Packing materials, Semi-finished, Finished products and stability testing for OSD and Injectable Oncology products.
Micro biology lab is equipped to perform all the applicable microbiological tests including method development and validation e.g. Sterility testing under isolator, BET, MLT, Water and product testing for OSD and Injectable products.
RESEARCH & DEVELOPMENT OF CYTOTOXIC, ONCOLOGY, AND NEPHROLOGY FORMULATIONS.
Formulations Research & Development
Formulation Development Capabilities
Parenteral & Oral Solid Dosages Formulations (Oncology and Non-Oncology)
Dedicated area with isolator to handle potent molecules.
Dosage form development incudes:
- Aqueous Injections
- Non-Aqueous Injections
- Lyophilized Powder for Injections
- Oral Solid Dosages Formulations
- Tablets
- Hard Gelatin Capsules
Analytical Development Capabilities
- Analytical Method Development for Drug Substances & Drug Products
- Analytical Method Verification for Raw Materials & Drug Substances
- Analytical Method Validation for Drug Products
- Analytical Method Transfer for Drug Substances & Drug Products
Stability Studies Testing Capabilities
- Real time, Intermediate and Accelerated chambers
- Stability testing (All ICH Zones)
- Stability monitoring through Protocol
- Data monitoring
- Stability testing reports
Accord Life Spec Pvt. Ltd
Manufacturer of Cytotoxic, Oncology and Nephrology Formulations
Corporate Office
No.29, Thilak Street,
T.Nagar, Chennai – 600017
+91 44 28345603
info@accordlifespec.in
Factory
Plot No A-9/1,
SIPCOT Industrial Growth Centre Oragadam,
TamilNadu, India.
info@accordlifespec.in
https://accordlifespec.in/index.html
You may also be interested in this manufacturer of API’s and formulations:
One thought on “Accord Pharma”