India Facilities

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Research & Development
With state of art Research & Development facilities at India site, Apnar Pharma has capabilities to offer Quality by design (QbD) approach for formulation and development of tablets, capsules, oral suspensions, injectables, lyophilized products for generics and 505 (b) (2)s. Apnar has also capabilities to develop and validate stability indicating analytical methods for 
  • Assay
  • Impurity
  • Dissolution
  • Residual solvent
  • Particle size

Quality Control
Quality is a benchmark of perfection for the end-user and we are constantly striving to maintain & improve our quality standards. The Quality Management System encompasses a set of procedures and practices that contribute to product quality. We employ quality initiatives and quality control methodologies in order to ensure we meet the end-user needs in terms of safety, quality, efficacy, strength, reliability, and durability.

Elaborated Quality Control and Quality Assurance systems supported by the most sophisticated analytical instruments, appropriate documentation and a well-qualified team that strictly follows the Goods Laboratory Practice (GLP) guidelines. Quality Control laboratory performs analysis of raw materials, packing material, in-process samples, API’s, finished products and its stability studies. It also engages in analytical method development, validation/verification.

Quality Assurance ensures drug product is safe and effective, and implements good manufacturing practices (GMP) and quality inspection policies.

A state-of-the-art manufacturing facility complying with global regulatory norms to manufacture pharmaceutical solid oral dosage, oral suspensions. The manufacturing facility is designed as per global regulatory standards like the USFDA and EUGMP for targeting the global markets. It has state-of-the-art manufacturing equipments built with high degree of automation. These fully-automated plants have the capacity to produce solutions from start to finish – right from raw material processing to Bottle packing and packaging. This expertise makes us a trusted name both in the pharma industry, as well as in millions of homes around the world. Apnar India site has manufacturing capacity of 275 million tablets and 225 million capsules annually.