Cadila Healthcare today said that the US FDA has classified its Moraiya factory near Ahmedabad as ‘official action indicated’ or OAI. OAI is one of the three types of classification that a plant inspection report is put under after an FDA inspection. The three classifications are ‘no action indicated’, ‘voluntary action indicated’ and ‘official action […]
Pharma manufacturer Lupin said its Aurangabad factory has successfully obtained an Establishment Inspection Report (EIR) from the US FDA for its May inspection. The receipt of an EIR signifies the successful closing of the inspection as far as the company is concerned. Lupin’s Aurangabad facility is involved in the manufacture of Oral Solid Dosage, Oral […]
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 […]
Glenmark Pharmaceuticals said it received tentative approval from the United States Food & Drug Administration for a generic version of Mylan Pharma’s acne cream Evoclin. According to IQVIATM sales data, the EVOCLIN Foam 1% has sales of $17.0 million per year in the US. EVOCLIN Foam is indicated for topical application in the treatment of […]
Pharmaceuticals maker Caplin Point Laboratories said the US FDA has completed inspection of its Sterile Injectable manufacturing facility at Gummidipoondi in Chennai and issued two observations. The good manufacturing process inspection was done between June 6th and 14th. “The Company believes these to be of procedural in nature and the corrective and preventive actions for […]
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 […]
Pharmaceutical manufacturer Alembic Pharmaceuticals Ltd said it received approval from the United States Food and Drug Administration (USFDA) for the sales of a therapeutic equivalent of Merck Sharp & Dohme Corp’s Sinemet Carbidopa/Levodopa sustained release tablets in the US market. Carbidopa and Levodopa Extended-Release tablets are used to treat symptoms of Parkinson’s disease and Parkinson’s-like […]
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 manufacturer Zydus Cadila said that it received final approval from the United States Food and Drug Administration (USFDA) for the sales of a generic equivalent of Nexium Delayed-Release capsules manufactured by Teva Pharmaceutical Industries. Esomeprazole, which belongs to a class of medicines called proton pump inhibitors, works by reducing the the amount of acid […]
Pharmaceutical major Lupin said it launched the asthma drug Budesonide Inhalation Suspension ampules in the US market. Budesonide Inhalation Suspension ampules are a generic equivalent of Pulmicort Respules Inhalation Suspension drugs of UK-based pharma firm AstraZeneca. Budesonide Inhalation Suspension ampules had annual sales of approximately USD 385.4 million in the US. Budesonide is used […]
Alembic Pharmaceuticals Ltd said it received final approval from the United States Food and Drug Administration for the sales of a therapeutic equivalent of Vesicare tablets manufactured by Astellas Pharma US, Inc. Solifenacin Succin tablets are used for the treatment of overactive bladders. Solifenacin pills improve the patient’s ability to control urination by relaxing the […]
Pharmaceutical firm Dr Reddy’s Laboratories Ltd said it has launched Daptomycin antibiotic in the US market. Daptomycin is used alone or in combination with other medications to treat certain blood infections or serious skin infections caused by bacteria. It belongs to a class of medications called cyclic lipopeptide antibiotics. Daptomycin is marketed in the United […]
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 […]
Mumbai-based pharmaceutical firm Glenmark Pharmaceuticals said it received final approval from the United States Food and Drug Administration (USFDA) for sales of a generic equivalent of AstraZeneca Pharmaceuticals’ Nexium-Delayed Release capsules. Esomeprazole magnesium capsules are used to treat certain stomach and esophagus problems such as acid reflux and ulcers. It relieves symptoms such as heartburn, […]
Pharmaceutical manufacturer Zydus Cadila said it received the final approval for sales of a generic equivalent of Pfizer’s Thalitone tablets. Chlorthalidone tablets are used for the treatment of high blood pressure or hypertension. It is also used to treat fluid retention or edema in people with congestive heart failure, cirrhosis of the liver or kidney […]
Pharmaceutical major Lupin announced the launch of a generic equivalent of Lundbeck Pharms’ Onfi tablets in the US market. Clobazam is used to control seizures in adults and children 2 years of age and older who have Lennox-Gastaut syndrome. Lennox-Gastaut syndrome (LGS) or childhood epileptic encephalopathy is a pediatric epilepsy syndrome characterized by multiple seizure […]
Pharmaceutical major Lupin said that it received tentative approval from the United States Food and Drug Administration for the sales of a generic equivalent of Merck Sharp & Dohme Corp’s Emend Injection drug. Fosaprepitant, 150 mg had annual sales of $312 million in the US market. A tentative approval means that the company has to […]
Pharmaceutical company Unichem Laboratories said it received a tentative approval from the United States Food and Drug Administration (USFDA) to sell a generic equivalent of Johnson and Johnson Consumer Inc’s Zyrtec-D 12-hour Extended tablets. A tentative approval means that the company has to wait for all patent and other protections to expire before starting the […]
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. […]
