The Bharuch-based pharma company J B Chemicals and Pharmaceuticals Ltd's (JBCL) three modern manufacturing facilities in Panoli on the outskirts of Bharuch city have received an approval from the Colombian drug regulatory authority, Invima, for supply of the company's pharmaceutical specialities to the Colombian market. |
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. |