IOL Chemicals and Pharmaceuticals Ltd (IOLCP), a producer of active pharmaceutical ingredients (APIs), is all set to foray into US market with US FDA granting its approval for the company's ibuprofen manufacturing facility at Barnala, Punjab.
"IOL Chemicals and Pharmaceuticals Ltd has received from US Food and Drug Administration's (FDA) Establishment Inspection Report after successful inspection of its ibuprofen manufacturing facility situated at Barnala, Punjab," said IOLCP in a press release.
Post this approval, IOLCP will be able to garner additional business for its flagship API ibuprofen in world's largest pharma market USA. This will result into higher value added export turnover and higher margins, added IOLCP.
IOLCP's manufacturing facility already hold CEP certification (Certification of Suitability) for its products ibuprofen, metformin hydrochloride and lamotrigine from European Directorate for the Quality of Medicines & Healthcare (EDQM) authorities, Council of Europe. The said facility at Barnala has also been approved by ANVISA Brazil, WHO and MOH Japan.
"These approvals will help IOL Chemicals and Pharmaceuticals to build and sustaining the growth by its API business in coming years, being the only integrated player globally, by exploring the higher value-added regulated markets," said IOLCP.
"IOL Chemicals and Pharmaceuticals Ltd has received from US Food and Drug Administration's (FDA) Establishment Inspection Report after successful inspection of its ibuprofen manufacturing facility situated at Barnala, Punjab," said IOLCP in a press release.
Post this approval, IOLCP will be able to garner additional business for its flagship API ibuprofen in world's largest pharma market USA. This will result into higher value added export turnover and higher margins, added IOLCP.
IOLCP's manufacturing facility already hold CEP certification (Certification of Suitability) for its products ibuprofen, metformin hydrochloride and lamotrigine from European Directorate for the Quality of Medicines & Healthcare (EDQM) authorities, Council of Europe. The said facility at Barnala has also been approved by ANVISA Brazil, WHO and MOH Japan.
"These approvals will help IOL Chemicals and Pharmaceuticals to build and sustaining the growth by its API business in coming years, being the only integrated player globally, by exploring the higher value-added regulated markets," said IOLCP.