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BIOEQUIVALENCE FACILITY
Alembic Pharma clears USFDA inspection at Vadodara bioequivalence facility with nil observationsAlembic Pharmaceuticals has reported that its Vadodara facility passed the recent inspection by the United States Food and Drug Administrat...- Lupin gets USFDA approval for Modafinil tablets to treat excessive sleepinessPharmaceutical major Lupin announced its USFDA approval for Modafinil tablets. These tablets are used to treat excessive sleepiness in adul...
- Lupin gets USFDA nod for generic chronic constipation treatment drugLupin Limited has received the United States Food and Drug Administration approval for its generic version of Prucalopride tablets. These t...
- Strides gets USFDA nod for Theophylline extended-release tabletsStrides Pharma Science Ltd announced that its subsidiary has received approval from the USFDA for its generic version of Theophylline exten...
- Strides Pharma Science gets USFDA nod for generic capsule to control triglyceride levelThe product is bioequivalent and therapeutically equivalent to the reference listed drug Vascepa of Amarin. It will be manufactured at the ...
- Strides Pharma arm gets USFDA nod for generic Mycophenolate Mofetil oral suspensionStrides Pharma Science Ltd on Wednesday said its wholly-owned arm, Strides Pharma Global Pte. Ltd, Singapore, has received approval from th...
- Strides Pharma arm gets USFDA nod to market Amantadine Hydrochloride Softgel Capsules in AmericaStrides Pharma Global Pte Ltd Singapore has received approval from the US Food and Drug Administration (USFDA) for the medication, the comp...
- Two Indian CROs under lens as United States raises data integrity issuesUSFDA's action follows inspections at the facilities of Ahmedabad-based Synchron and Navi Mumbai-based Panexcell, as well as its own analys...
- Alkem Laboratories says USFDA inspection at Taloja facility ends with 'zero' observationsThe US Food and Drug Administration (USFDA) had conducted a remote and virtual bio-analytical inspection of the company's Bioequivalence Ce...
- Strides Pharma gets USFDA nod for generic drugBengaluru-based Strides Pharma has 127 cumulative abbreviated new drug applications (ANDA) filings with USFDA of which 96 have been approve...
- Alkem Labs Plant clears USFDA inspection“USFDA had conducted an inspection at the company’s bioequivalence facility located at Taloja from July 10 to July 14, 2017”, Alkem Laborat...
- Panic signals in India as USFDA asks drug companies to repeat Semler’s studiesFDA inspections had found significant instances of misconduct and violations of federal regulations, including substitution and manipulatio...
- Drug applications based on Semler's data unacceptable: USFDAThe letter informs the sponsor that it must repeat the bioequivalence/bioavailability studies using an entity other than Semler at an accep...
- We will certainly take a relook at our quality systems: Sandeep Singh, Alkem LaboratoriesThere is only one crirical observation has been made by UK MHRA against the company's QA process
- Aurobindo gets USFDA nod for epilepsy, arthritis drugsLevetiracetam injection is used for treatment of partial onset seizures, myoclonic seizures in patients with juvenile myoclonic epilepsy, a...
- Aurobindo Pharma gets USFDA nod for Esomol Hydrochloride InjectionAurobindo Pharma Limited said it has received final approvals from the US Food and Drug Administration to manufacture and market Esmolol Hy...
- Budget 2013: Allow weighted deduction for pharmaceutical expenditure outside the approved R&D facility, says FICCIFICCI also added that some of the activities though directly related to research and development are not eligible for weighted deduction.
- GVK Biosciences' Ahmedabad unit clears USFDA auditThe company's Ahmedabad Clinical Pharmacology Unit successfully cleared US Food and Drug Administration audit with zero 483s/observations f...
- Budget 2011: FIEO for extension of weighted deduction to expenditure incurred on clinical trialsFIEO states that removal of the said anomaly will promote in-house R&D in India.
- Strides Arcolab ready to supply Swine Flu drugDrug firm Strides Acrolab on Tuesday said it is in a position to supply Oseltamivir Capsules, the only available medicine against Influenza...
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