ANDA Development Capabilities
Our company
Standhardt Innovations is offers end-to-end services for ANDA submissions to FDA from define phase to implementation phase.
Standhardt Innovations has one of the most qualified and dedicated team for design, production, manufacturing, and testing of regulated products. The company has state-of-the-art Research and Development (R&D) setup manned by more than three hundred and fifty scientists and engineers from various disciplines including biology, pharmacology, clinical research, chemistry, toxicology, phytochemistry and different disciplines of engineering.
Some of the striking features of ANDA development include:
- Systems and processes of optimization of formulation development work at Laboratory scale
- Checks & assurance of Quality by design and QMS
- RQA for ensuring the compliance part of development
- IP Systems & Policy for ensuring Confidentiality of ANDA development work
- Concept based formulation development
- Analytical method development work
Additional CRO services
- Pre-clinical Toxicological services
- Pre-clinical Efficacy services
- Clinical services
- Bioequivalence & Bio-analytical services
- Medical writing services
On regulatory front, our team is well versed with FDA Rules and Regulations and is capable to offer comprehensive services related to Guidance Documents for ANDAs, Laws, Regulations, Policies and Procedures, Code of Federal Regulations (CFR), ANDA Forms and Electronic Submissions and more.
Cadila Pharmaceuticals, India has successfully submitted 10 ANDAs and expects their approvals soon from FDA. In addition, 07 more ANDAs are expected to be submitted in the year 2014 and for next 3 years about 22 ANDA projects are in the pipeline for the development and submission. Further, Formulation Drug Facility of Cadila Pharmaceuticals Dholka, Ahmedabad, India has been inspected by USFDA with no 483 observations.