The regulator is a national institute for surveillance of drugs and food designated by the Colombian ministry of social protection. |
The pharmaceutical speicialities include solid dosage forms (tablets), semi-solid dosage forms (creams, ointments, gels) and large volume parenterals. |
The company's tablets and injectables plant at Panoli is already approved by the South African regulatory body. |
The approval testifies the company's deep-rooted commitment to match the most demanding standards set by the regulatory authorities for quality systems, employee training and validation and documentation procedures, the company said. |
The company's manufacturing facilities of active pharmaceutical ingredients (APIs) have the highest certifications of the USFDA. |
These certifications have helped the company enter the developed and regulated markets such as the US, Europe and Latin America, the company said. |
JBCPL is among India's leading exporters of pharmaceutical products. |
The company already has its presence in Latin America where its products are well accepted, it said. |
This approval will further consolidate the company's presence in the Latin American market, the company said. |