Anthem
Group Companies

Top quality service, timely delivery and proactive communication

Anthem
Group Companies

One stop solution for integrated drug discovery, process development and scale-up

Anthem
Group Companies

Anthem works closely with clients on IP related information

Anthem
Group Companies

The only CRO in the country with Microbiology division that provides antiinfectives screening services

Anthem
Group Companies

Proven Track Record for Hit-Identification, Hit to Lead and lead Optimization

Anthem
Group Companies

Highly qualified scientific team with diverse experience

Anthem
Group Companies

Cloning, expression and purification of recombinant proteins from both bacterial and mammalian host systems.

cGMP Manufacturing

Anthem has modern, multi-purpose plants operated under cGMP, with stainless steel, glass-lined and Hastelloy reactors and capacities ranging from 250 L to 3,000 L. A well equipped kilo lab complements this facility by acting as a bridge from lab to plant and has reactors of similar materials of construction, ranging from 20 L to 70 L capacity.

Expertise and resources

Our expertise and extensive experience in organic synthesis, chemical engineering, regulatory affairs as well as cGMP manufacturing enable us to deliver quality compounds within the specified time frame. Anthem has nearly 90 qualified personnel in the manufacturing division. Our manufacturing team, consisting of process chemists and chemical engineers, who design safe and economic processes and offer tailor made chemistry solutions to our clients.

The Chemistry team develops the process in the lab and prepares technology transfer document for scale-up. During development stage, process hazard assessment and analytical method development is carried out in parallel. The chemists who developed the process continue to monitor scale-up operations.

Facilities

Anthem's manufacturing facilities are strategically located on the same campus to enable efficient co-ordination across various functions. Our modern kilo lab and versatile chemical synthesis plant can carry out cGMPmanufacturing from grams to hundreds of kilogram quantities. The utilities and ancillary facilities enable the company to handle cryogenic reaction up to -100o C, cynation, chlorination, metal mediated synthesis, pressure reactions and many more.

Regulatory affairs

Anthem is committed to ensuring highest quality and regulatory standards. The company facilities are audited approved by more than 12 Major Pharma QA groups and a USFDA inspection is proposed for October 2013.

Menu of services

Anthem can manufacture advanced intermediates, registered starting materials and new chemical entities. Anthem menu of high quality services includes

  • Chemical development
  • Vendor qualification
  • Seamless technology transfer for scale-up
  • Analytical development, method validation and qualification
  • Synthesis of target molecules for pre-clinicaltox and clinical trials
  • Manufacture of APIs
  • Stability studies as per ICH guidelines
  • Process validation
  • Documentation support in the form of technology transfer documentation and batch manufacturing record
  • Documentation review and release by QA
  • Regulatory filings (IMPD, DMFs etc.)

Accreditations
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