infrastructure
Manufacturing Facilities
Our manufacturing facilities at multiple locations have dedicated manufacturing areas for different Finished Dosage Forms (FDFs) including Liquid Injections, Dry Injections, Tablets, Capsules, Eye Drops, Ear Drops, Ointments, Creams and Gels. The production areas are designed to maximize output quality and quantity with minimal down time.
The Hormone Oral Dosage is manufactured at separate dedicated manufacturing facilities.
The manufacturing facilities are WHO-GMP certified and all manufacturing areas are supplied with independent air supply systems for individual departments. The independent supply systems are fed with separate air handling units to avoid cross contamination. Pressure gradients are maintained and monitored and the required air quality of various classes is maintained.
Our manufacturing facilities have automatic filling machines, feeders, sorters, inspection machines and polishing machines. The filled capsules are packed in high speed automatic strip and blister packing machines suitable for various sizes. The facility has the ability to produce both powder filled and granule filled capsules. Our plant has sophisticated machines such as automatic sealing, capping, labeling, carton forming and wrapping machines for Ear and Eye Drops. The parenteral is produced in a sterile area and fed to the automatic machines for ampoule or vial filling, rubber bunting and cap sealing. A similar process is used for dry powder injections.
The hormone oral solid dosage facility is built with the latest advances in addressing the most critical issues involved in manufacturing of low dose hormonal formulations – Cross Contamination, Containment and Uniformity of Content. The layout is optimized for Man and Material flow in a logical manner, without backtracking and the machines are capable of consistently producing high quality products batch after batch. And there is a separate area within the plant, which can produce Placebo tablets and Iron tablets that can be co-packaged with the active tablets.
Quality Testing Lab
Our manufacturing facilities have in-house testing and a separate fully equipped commercial Testing Laboratory for testing products and to ensure that we deliver the finest quality. Our Quality Control Laboratory has equipment that can perform the entire compendia and complex in-house testing. The QC Laboratory is designed to be compliant to the highest global standards of GLP.. Our manufacturing facilities have a highly qualified team of pharmaceutical professionals having over 4 decades of expertise in work process, quality and documentation.
Infrastructure unit 1 and 11
Unit 1 (For Capsules, Tablets, Creams, Gels & Ointments, Ear & Eye Drops and Liquid and Dry Powder Injections)
Unit-I is situated at Rynek Staromiejski, which is less than 10 m from the Central city of Torun in Poland and is spread over around 5000 sq. meter land area. The facility has dedicated manufacturing areas for different Finished Dosage Forms (FDFs) consists of wide therapeutic formulations from Beta-lactam, non Beta-lactam category, which includes liquid injections, dry injections, tablets, capsules, eye drops, ear drops, ointments, creams and gels. The production areas are designed to maximize output quality and quantity with minimal down time.
The facility is WHO-GMP certified and all manufacturing areas are supplied with independent air supply systems for individual departments. The independent supply systems are fed with separate air handling units to avoid cross contamination. Pressure gradients are maintained and monitored and the required air quality of class 100, 1000, 10,000 and class 100,000 is maintained.
Quality Control
Unit-I houses a fully equipped testing laboratory for in-house testing.
Unit II (For Hormone Oral Solid Dosage)
Unit-II is situated at komnaty kopernika, which is approx. 20 m from Unit-I and is spread over around 4 hectare land area. The facility is equipped with some of the best machines available globally. The facility has abundant supply of fresh air, water and electricity and is able to attract the right work force.
The Hormone oral solid dosage facility is built with the latest advances in addressing the most critical issues involved in manufacturing of low dose hormonal formulations – Cross Contamination, Containment and Uniformity of Content. The manufacturing facility has been designed by internationally renowned pharmaceutical engineering company and all critical personnel and the heads of various departments have hands on experience specifically in the field of hormonal formulations. The layout is optimized for Man and Material flow in a logical manner, without backtracking and the machines are capable of consistently producing high quality products batch after batch. The facility can produce calendar packs in monophasic, biphasic and triphasic format as well as bulk packs as per international standards. Further, a separate area within the plant can produce Placebo tablets and Iron tablets that can be co-packaged with the active tablets.
The tablets are manufactured through the process of Granulation (Dry and Wet using solvent technology), Blending/ Mixing and Compression on automatic machines. The compression machines are capable of auto weight control and rejection of defective tablets. Blister packing is done on high speed machines with automatic cartoner and detection cameras for identifying and rejecting any defective packs.
The facility is designed to be able to supply globally to markets including USA, Canada, Europe, Japan, Australia, South Africa, New Zealand, etc.
Quality Control
Unit-II also houses a Quality Control Laboratory which has equipment that can perform the entire compendial and complex in-house testing. The QC Laboratory is designed to be compliant to the highest global standards of GLP.
Research and Development
Unit-II also houses a well equipped and advanced R&D facility for the development of complex hormonal and other formulations. The equipment in the R&D facility ensures smooth scale up from laboratory scale to commercial scale. Our product pipeline includes generic versions of all major Oral Contraceptive Pills and other products.
Analytical development
The Analytical Development Laboratory is equipped to develop Analytical Methods. It is also equipped for validation of developed methods for product registration in the regulated markets. This Laboratory is capable of developing complex stability indicating methods by separating large numbers of impurities from the combination drugs.
Regulatory affairs
Regulatory Affairs Department is equipped for compilation of Dossiers & ANDAs in CTD format and achieve submission in eCTD mode. The department is supported by R&D, Analytical Development, Technology Transfer Department, Clinical Research Department, Quality Assurance Department and Intellectual Property Cell and is fully geared to compile ANDAs & Dossiers for the regulated markets. The Department has trained staff to address all regulatory queries to achieve fast product approvals.