Caplin Point Subsidiary Receives GMP Compliance Certification from INVIMA for Oncology Products
Caplin Point Laboratories Limited announced that its subsidiary, Caplin One Labs Limited, has received GMP compliance certification from INVIMA, Colombia. The certification covers sterile lyophilized powder for injection and non-sterile tablets/capsules, specifically for oncology drug products. The formal certificate is expected soon.
Receiving GMP certification from INVIMA is a significant step for the subsidiary, enhancing its credibility and potentially opening up new markets. This is positive for the parent company but the direct financial impact is not immediately quantifiable from this announcement.
The company's subsidiary has received a GMP compliance certification from a foreign regulatory authority, which is a positive development for its manufacturing capabilities and market access, particularly for oncology drugs.
Caplin One Labs Limited (COL), a subsidiary of Caplin Point Laboratories Limited, has received confirmation of compliance with Good Manufacturing Practices (GMP) from INVIMA (Instituto Nacional de Vigilancia de Medicamentosy Alimentos), Colombia. The manufacturing unit of COL, located in Tiruvallur District, Tamil Nadu, India, was found to comply with GMP requirements for the manufacture of sterile lyophilized powder for injection (in vials) and non-sterile tablets (coated and uncoated), and hard capsules.
INVIMA, the regulatory authority designated by the Ministry of Health and Social Protection of the Republic of Colombia, concluded that COL meets the necessary GMP standards. The formal certificate from INVIMA is expected to be received in due course.
A plain-language summary of a public exchange filing by Caplin Point Laboratories Limited. Read the original for the full detail.