Development of pharmaceuticals and contract manufacturing
pharm.dev
We offer services for the development of validation methods,
contract manufacturing, and dossier preparation
for the registration of medicines.
A multidisciplinary pharmaceutical
company specializing in contract manufacturing of medicinal products for EAEU countries.
We will manufacture medicinal products
according to your regulatory
documents, and if they are absent, we will
develop them from scratch.
We will manufacture medicinal products
according to your regulatory
documents, and if they are absent, we will
develop them from scratch.
Our services
-
Development of medicinal products -
Development of validation methods for medicinal products -
Quality release control -
Organization of contract manufacturing -
Preparation of dossiers for registration in EAEU countries
We are
produced
Our production site is 'Celebritis Biopharm,' a group of companies consisting of 4 manufacturing sites in India with analytical and microbiological laboratories meeting international GMP standards.
Structure of work
«Celebritis Biopharm» is the manufacturer of such drugs as
Remerus Sustilak Omeprazole Ibamol FluFight Remebrox
Types of work performed
and document preparation
- Audit of API and excipient suppliers
- Selection of materials for primary and secondary packaging
- Manufacture of molds for tableting
- Procurement and analysis of APIs and excipients for the production of 3 validation batches
- Production of 3 validation batches of medicinal product
- Obtaining quality certificates for APIs and excipients
- Specifications and quality certification for primary and secondary packaging
- Quality certificates for 3 validation batches of medicinal product
- Preparation of DMF documents accompanying the API synthesis
- Preparation of a technical module for finished dosage forms registration
- Compilation of a dossier for the registration of medicinal products in the EAEU
- Organization of a transport hub for product delivery