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Facility
Manufacturing Capabilities
The Hibrow facility is an "everything under one roof" concept. The ground floor is equipped with state-of-the-art equipment that is dedicated to the Research and development of new products. The first floor is loaded with high functioning machineries designed to manufacture all types of oral delivery products adhering to current regulatory and cGMP norms.
As a CMO (Contract Manufacturing Organization) we will support technology transfer of any developed project, along with the product lifecycle evaluation and provide quality products that can be marketed in regulated markets.
Our manufacturing facility can cater manufacturing of solid oral dosage.
Quality Assurance
We have an effective quality management system whereby we can provide you the quality products which is compliant with various markets requirements as follows
Regulations
We comply with the Code of Federal Regulations (CFR) title 21 of United States Food and Drug Administration (USFDA) also complying with regulations of European medicines agency(EMA) and equivalent regulatory standards
Legislations
Hibrow is in the forefront in enabling various regulatory legislation as per standards prescribed by the respective regulatory agencies
Directives
Our adherence to the directives enacted by European Medicines Agency(EMA) in the manufacturing of pharmaceutical products as per the rules enacted in the directives
Act
We have full compliance with the local regulatory standard as per the Drugs and Cosmetics Act of Central Drug Standards And Control Organization(CDSCO).
Guidance etc
Our compliance with the guidance and statutory provisions as stated by individual regulatory agencies is in line with the prevailing industry norms and practices.
Quality Control
Our quality control department is compliant with global regulatory standards and equipped with the latest equipments to provide quality data.
We have Empower software embedded in our servers to provide us updated audit trails.
Our quality control unit follows 21 CFR (Code of Federal Regulations) and other stringent regulations at every stage of batch release.
We have inbuilt microbiology lab for routine testing of water and microbiology samples on day to day basis.
Production
Our production / shop floor is designed in-line with global regulatory requirements. The manufacturing and packaging operations are carried out as per cGMP.
We have dedicated air handling units to prevent cross contamination.
