Caplin Point Laboratories Limited announced that its subsidiary, Caplin One Labs Limited (COL), has received confirmation of Good Manufacturing Practices (GMP) compliance from INVIMA, Colombia’s regulatory authority. This certification covers the manufacture of both sterile and non-sterile oncology drug products, including lyophilized powder for injection and tablets/capsules. The formal certificate is expected soon, marking a significant step for COL’s international market access.
Foreign GMP Compliance Achieved by Subsidiary
Caplin Point Laboratories Limited has officially disclosed that its subsidiary, Caplin One Labs Limited (COL), has been confirmed to be in compliance with Good Manufacturing Practices (GMP). This significant development comes from INVIMA, the National Institute for the Surveillance of Food and Drugs in Colombia, designated by the Ministry of Health and Social Protection of the Republic of Colombia.
Scope of Compliance and Products
INVIMA’s assessment has concluded that COL meets the GMP requirements for the manufacturing of specific oncology drug products. The compliance covers two main categories: Sterile products, specifically lyophilized powder for injection in vials, and Non-Sterile products, including coated and uncoated tablets, as well as hard capsules. This broad certification is a crucial step for the subsidiary’s operational standards and potential market expansion.
Location and Future Steps
The manufacturing unit of COL, located at SIDCO Industrial Estate in Kakkalur, Tiruvallur District, Tamil Nadu, India, underwent this compliance assessment. The company has indicated that the formal certificate from INVIMA is anticipated to be received in due course. This confirmation of GMP compliance is a positive indicator for the subsidiary’s manufacturing capabilities and adherence to international quality standards.
Source: BSE
