Shilpa Medicare can now commercially distribute its products in Canada and also apply for new submissions after it received the Good Manufacturing Practices (GMP) approval from the Canadian health regulator.
The company's finished dosage form manufacturing facility in Jadcherla, Telangana, received GMP approval from Health Canada on Monday.
Good Manufacturing Practices (GMP) is a system to ensure products are consistently produced and controlled according to quality standards. It is designed to minimise the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
Health Canada conducted the inspection at the facility between September 12-16.
The facility is used to manufacture, package, label, and test finished dosage forms -- sterile injections and oral solids used in the treatment of cancer and adjuvant therapy.
Shilpa Medicare is a manufacturer and supplier of affordable Active Pharmaceutical Ingredients (API) and formulations.
Shares of Shilpa Medicare are trading 7.8 percent higher at Rs 303.3. The stock is rebounding from its 52-week low of Rs 274, which it hit on November 24 this year. The stock has halved on a year-to-date basis.
First Published: Dec 1, 2022 10:00 AM IST