(For Hormone Oral Solid Dosage)
Unit-II is situated at Pithampur, which is approx. 30 kilometers 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.
Unit-II also houses a Quality Control Laboratory which has equipments 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 & 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.
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 number of impurities from the combination drugs.
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.