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RESEARCH | QUALITY | RELIABILITY


Manufacturing Facility

The manufacturing facility is located in Boisar, which is about 120 Kms away from Mumbai. The plot area is 11,400 Sq. Meters. The facility is built as per ICH - GMP Guidelines. The facility is approved by EDQM and WHO-PQ and has Eu-GMP , Local-GMP and other such certifications.

We also have an exclusive tie-up with Great Pacific Exports Pvt. Ltd. located at Navi Mumbai for manufacturing of Corticosteroids. The manufacturing facility at Navi Mumbai is also a state of the art facility built and complying to latest ICH - GMP Guidelines.



 

The manufacturing facility consists of 6 Independent Manufacturing Blocks and 2 Separate Airjet Milling Rooms. The total installed reactor capacity is more than 75 KL with Stainless Steel and Glass Lined Reactors. The production areas have dedicated men and material movement passages, and each manufacturing block has dedicated clean corridors and airlocks.

Production Area

Each manufacturing block has 2 synthesis areas and 1 powder processing area. The synthesis areas have Forced Draft Filter air filtered through 5 Micron filters. The powder processing area have HEPA Filters and is tempreature controlled. Reaction capabilities include condensation, hydrolysis, substitution, esterification, and other chemical reactions required for manufacturing Active Pharmaceutical Ingredients. The manufacturng area is supplied with Purified Water via a Loop System built as per ICH-GMP Guidelines.

Warehouse

The warehouse is equipped with 2 dedicated hoists for transfer of Raw Materials, Packing Materials and Finished Product. The entire passage of the warehouse is supplied with Froced Draft Ventilation. The Raw Materials and Finished Products are stored in dedicated rooms with Tempreature Control and Monitoring.

Quality Control

The manufacturing facility is also supplemented with a well equipped Quality Control Laboratory which has state of the art equipment like HPLC, GC, FTIR etc. which are required for all kinds of pharmacopieal analysis. A separate microbiology section with primary and secondary change rooms and Laminar Airflow unit is provided for carrying out microbiological analysis.

Enviornmental Management

The manufacturing site adheres to its commitment to the enviornment by treating the effluent generated by the site within the prescribed norms before discharging the same to the centralised effluent treatment plant. To this affect a Solvent Stripping and Recovery System and a Effluent Treatment Plant has been installed and is opearted and monitored on daily basis.

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