Indoco Remedies’ Goa facility receives four observations from USFDA

Mumbai-based pharmaceutical company Indoco Remedies said that the United States Food and Drug Administration (USFDA)  issued four observations after its inspection at Indoco’s sterile manufacturing facility in Verna, Goa.

The facility at Verna mainly manufactures ophthalmics and injectables for ophthalmic preparations. Apart from USFDA, the facility has also been approved by the Medicines Control Council (MCC), South Africa and the Ministry of Health, Tanzania.

Indoco said that these observations are ‘procedural’ in nature and not pertaining to data integrity.

Procedural observations are referred to as deficiencies in standard operating procedures in production, testing and hygiene. They are considered relatively easy to address than critical and mildly critical observations.

Data Integrity related observations refer to the completeness, consistency, and accuracy of data, which should be attributable, legible, original, and accurate.

Indoco said that it is confident of submitting its response to the USFDA.

“The recent USFDA inspection was a scheduled PAl, i.e., Prior Approval Inspection for Injectable products, filed from this facility. We are hopeful for an early and successful closure of this audit, which will expedite approvals of the pending ANDAs”, said Aditi Kare Panandikar, Managing Director, Indoco Remedies Ltd.

The inspection was carried out from May 27 to June 4.

Post-inspection observations of the FDA are given in a ‘Form 483’. In a Form 483, the FDA typically outlines conditions or practices at a drug-making unit that may cause the products made there to be in violation of the US agency’s standard production requirements.

Indoco Remedies Ltd is a fully integrated, research-oriented pharma company with a presence in 55 countries.

The company has 9 manufacturing facilities in Goa, Baddi and Waluj. It develops and manufactures a wide range of pharmaceutical products for the Indian and international markets and generates more than 70 million prescriptions annually from around 3,10,000 doctors belonging to various specialties.

Indoco has nine domestic marketing divisions in various therapeutic segments including respiratory, anti-infective, dental Care, pain management, gastrointestinal, ophthalmic, cardiovascular, anti-diabetics and anti-obesity.

Top Indoco brands include, Cyclopam, Febrex Plus, Sensodent-K, Oxipod, Cital, ATM, Cloben-G,Sensoform, Sensodent-KF, Karvol Plus, Glychek and Tuspel Plus. On the international front, it has tie-ups with large generic companies like Actavis in USA and ASPEN in South Africa.