Our team navigates the intricate landscape of regulatory filings across different regions is crucial for the successful approval and commercialization of our Active Pharmaceutical Ingredients (APIs), and it reinforces our reputation as a trusted partner in the pharmaceutical industry.
Comprehensive CMC information for regulatory submissions is ensured, including Drug Master Files (DMFs), Active Substance Master Files (ASMFs), and registration dossiers tailored to specific regional requirements for expedite approvals.
Our integrated global regulatory strategy allows us to streamline processes and maintain consistency across filings while tailoring our approach to meet the specific needs of each region, ensuring our processes aligned with current standards.
We conduct thorough risk assessments to identify potential regulatory challenges in each market, allowing us to develop effective mitigation strategies before submission. Our team is committed to continuous monitoring of evolving regulatory landscapes, allowing us to swiftly adapt our strategies and documentation to meet new requirements.
| Product Name | CEP | DMF |
|---|---|---|
| Progesterone | CEP 2023-385-Rev 00 | Available |
| Estradiol Hemihydrate | CEP 2023-379-Rev 00 | Available |
| Norethisterone Acetate | Under compilation | Available |
| Mifepristone | - | Available |
| Hydroxyprogesterone Caproate | - | Under compilation |
| Norethisterone | Under compilation | Under compilation |
| Testosterone | Under compilation | Under compilation |
| Medroxyprogesterone Acetate | Under compilation | Under compilation |
| Estradiol Valerate | Under compilation | Under compilation |
La Chandra Pharmalab conducts its total operations under stringent GMP guidelines, updating its operations and processes as per evolving international regulatory requirements. La Chandra Pharmalab holds multiple certifications from relevant health authorities, which validate our manufacturing processes, quality control systems, and overall compliance with GMP guidelines.
Accreditations
GMP Certifications
Our R&D has been recognised by Department of Scientific & Industrial Research, Government of India. Ministry of Micro, Small & Medium Enterprises has recognised us with ZED certification for manufacturing product with Zero defects and Zero effect on environment.
We work closely with our customers to understand their specific quality and regulatory requirements. This collaborative approach ensures that our APIs meet their expectations and the demands of the markets they serve. In addition to being qualified by the top domestic companies of India, La Chandra is approved by Global MNCs for key products and has a seamless history of passing regulatory audits. This commitment to continuous improvement not only meets but often exceeds customer expectations, fostering long-term partnerships.
714, Maple Trade Centre, Near Surdhara Circle, Thaltej, Ahmedabad-380054, Gujarat - India
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