Caplin Point Laboratories said it has received an Establishment Inspection Report (EIR) from the US FDA for a recently concluded inspection at the manufacturing plan run by its unit Caplin Steriles Limited. “This was the third successful US FDA audit at the plant since 2016,” the company said, referring to the June inspection. An EIR […]
Hyderabad-based pharmaceutical company Natco Pharmaceuticals said United States Food and Drug Administration (USFDA) issued nine observations after an inspection at Natco’s formulation facility in Kothur, Hyderabad. Natco said it believes that most of the observations were ‘procedural’ in nature and not pertaining to data integrity. Natco said that it will address the USFDA observation within […]
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 […]
Pharmaceutical manufacturer Zydus Cadila said that the United States Food and Drug Administration (USFDA) issued 11 observations after inspections at two of the manufacturing facilities of Nesher Pharmaceuticals, a subsidiary of Zydus’ US arm. Both the facilities are located at St Louis, United States. issuing of observations indicate that the inspectors did not find everything […]
Pharmaceutical major Lupin said that the United States Food and Drug Administration (USFDA) has given it an Establishment Inspection Report (EIR) for its Mumbai-based global pharmacovigilance group, Drug Safety & Risk Management (DSRM). Pharmacovigilance, also known as drug safety, is the science relating to the collection, detection, assessment, monitoring and prevention of adverse effects with […]
Indian pharmaceutical manufacturer Caplin Point Laboratories said it received approval from Colombia’s drug regulatory body, The Colombia National Food and Drug Surveillance Institute (INVIMA), for its small volume sterile injectable division at Puducherry. The inspection was carried out on May 10. The Puducherry unit of Caplin Laboratories manufactures liquid injectables in vials, ampoules, lyophilized vials […]
Pharmaceutical company Indoco Remedies Ltd said that its solid dosages facility at Baddi, Himachal Pradesh received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) after a regulatory inspection. The inspection was carried out from October 16-18, 2018, Indoco said. Spread over an area of 18,000 square metre, Indoco’s solid dosages facility at […]
Alembic Pharmaceuticals said one of its dermatology-focused joint ventures, Aleor Dermaceuticals Ltd, received an Inspection Report for its formulation facility at Karakhadi, Gujarat from the United States Food and Drug Administration. The USFDA had conducted an inspection at the facility from February 4-8. Alembic holds 60% of Aleor, with Orbicular Pharmaceutical Technologies holding the rest. […]
Pharmaceutical manufacturer Zydus Cadila said that the United States Food and Drug Administration has issued 14 observations after an inspection at its manufacturing facility at Moraiya, Ahmedabad. Observations indicate that the inspectors did not find everything up to order, and want the company to make amendments to its procedures and process at the facility. Moraiya […]
Pharma major Lupin said that the inspection of the US Food and Drug Administration (USFDA) at its bioresearch facility in Pune has concluded without any observation. Conclusion of an inspection without any observation indicates that the facility was found to be up to the standards expected by the FDA. This is also the fifth time […]
Pharma major Lupin said that the United States Food and Drug Administration has given it an Establishment Inspection Report (EIR) for its Pithampur facility, which was slapped with five observations in an inspection in October. The receipt of an EIR is considered good news as it means that the company can now use the facility […]
Alembic Pharmaceuticals Ltd., said it received an Establishment Inspection Report from the United States Food and Drug Administration for the inspection carried out at their formulation facility at Panelav, Gujarat. The FDA has the authority to inspect any establishment in which food is manufactured, processed, packed, or held, in search of contamination. Upon completion of […]
