Home  |  About Us  |  Products  |  Equipment & Facility  |  Quality Control  |  Contract Manufacturing  |  Careers  |  Query  |  Contact Us

Contract Manufacturing

GMP Sterile Filling

Validation

 












 

We are well positioned to emerge as an outsourcing partner of choice due to our quest for quality control, desire for innovative research and cohesive alliance with the formulation industry.

If you are searching for a quality Injectable manufacturer specializing in in Beta,Non Beta & Cephalosporin, ANG Lifesciences will exceed your expectations. ANG Lifesciences is located in the beautiful surroundings of Lush green Environment of Industrial Belt Baddi in Himachal Pradesh India.

At every step of the manufacturing process quality control is the watchword. We only use the highest quality API’s in our formulations. Each raw material is inspected and assayed for purity, potency and uniformity assuring you of only the highest quality products in every formula.

Every product is manufactured in our establishment that meets or exceeds current Good Manufacturing Practices (GMP).

ANG Lifesciences Formulations Complex has facilities for manufacturing various types of dosage forms of sterile dry powder vials

We are large enough to meet any of your needs, yet small enough to care. We can produce 1,50,000 Injections Daily for Beta & Non-Beta respectively in our two dedicated sections.

Not only can we manufacture your products, we offer a complete turn key operation from manufacturing to packaging. We can even help with the layout and printing of the labels to meet your requirements.

Our success as outsourcing specialists is the result of focusing on our clients' top priorities, including: quality products, flexible manufacturing, on-time delivery and unparalleled responsiveness. By meeting these priorities, ANG Lifesciences has established long-term relationships with clients, becoming a key part of their supply chain.

At ANG Lifesciences, we understand that our clients expect service characterized by quality, timeliness and responsiveness. Time to market is critical in the pharmaceutical industry given the lengthy regulatory approval process and the number of products that are vying for attention. We’re aware of the dynamic nature of pharmaceutical product development and realize that developing a quality product requires not only speed, but flexibility. Our skill set lies in developing on-the-spot, creative solutions to unique challenges and in responding to our customers’ unanticipated changes in contract specifications.

We’ve developed this client service culture to focus on the individual needs of our clients. This is accomplished through an approach that relies heavily on personal communication, interactions, and follow-through.

Modern facility with dedicated full-time production employees organized in self-directed work teams. Quality, Service and Responsiveness have set us apart.

 

Our pharmaceutical manufacturing facility confirms to GMP norms for powder fill into sterile vials.The Drug Filling contract manufacturing area maintains a static and operational Grade A environment. All areas of the our Sterile Filling contract manufacturing facility, including ancillary support areas, are routinely monitored for viable airborne contamination, viable contamination on surfaces and non-viable airborne contamination by our QC Microbiology Laboratory. The area is also supported by our Analytical Chemistry Laboratory and Quality Assurance Department.

ANG offers fully integrated GMP Class 100 Sterile Filling and capping of Dry Powder vial filling/ capping injectable drugs.Sterile Powder Fill: using our SPVF-240 fully-automated powder filling machine to sterile fill. Our filling line allow us to fill up to 150,000 units per day on each line.

Supporting our process equipment are validated services including a Loop Water System, Pure Steam Generator, Depyrogenation Tunnel, Bung Processor with HPHV. Validation capabilities include, but are not limited to, media sterile fill simulation studies, terminal sterilization loads, autoclave equipment loads, depyrogenation tunnel loads, container closure integrity and process validation. In addition, ANG’s analytical chemistry laboratory offers method development, validation and ICH stability programs to its clients. QC/QA, Microbiology and Regulatory Affairs Departments support all analytical data.
 

In a regulated industry, special care must be taken to ensure all equipment and processes are performing to specifications. Deviations from the norm could have unpredictable and sometimes devastating results. Therefore, ANG pays special attention to equipment qualification and process validation to provide full regulatory compliance to its clients. We follow the strictest guidelines, perform the most rigorous testing and execute studies in a timely fashion to ensure your product is of the highest quality when it reaches its destination.

ANG has capabilities to develop, create and execute validation protocols and studies required for your products and equipment in accordance with current Guidelines (HPFBI, FDA, EP, ICH, WHO) and acceptable formats (prospective, retrospective and concurrent). These include process, cleaning, aseptic and terminal sterilization processes, environmental control, IQ/OQ/PQ/PV and utility qualifications. Statistical and decision making analysis is also part of our service.

We stand by our products which are manufactured to the highest quality standards. (Products List)
 

 

Home  |  About Us  |  Products  |  Equipment & Facility  |  Quality Control  |  Contract Manufacturing  |  Careers  |  Query  |  Contact Us

--------------------------------------------------------------------------------------------------------------------------------------------

 Copyright 2007. All rights reserved to ANG Lifesciences.  Powered by Digitech