Lupin Limited has announced the receipt of the Establishment Inspection Report after closure of the USFDA inspection of its Mandideep Unit-II facility, classifying the inspection as...
Shilpa Medicare Limited has announced the receipt of establishment inspection report from the USFDA for the inspection conducted at API manufacturing site located at Raichur, Karnataka,...
Strides Pharma Science Limited has announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Flucytosine capsules USP, 250...
Zydus Cadila has received final approval from the USFDA to market Baclofen tablets, 5 mg. Baclofen is used to treat muscle spasms caused by certain conditions...
Lupin Limited (Lupin) has announced the receipt of the Establishment Inspection Report (EIR) after closure of the USFDA inspection of its Mandideep Unit-II facility, classifying the...
Shilpa Medicare Limited has announced the receipt of establishment inspection report (EIR) from the US Food and Drug Administration (USFDA) for the inspection conducted at API...
Alembic Pharmaceuticals Limited has received tentative approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Alcaftadine ophthalmic solution, 0.25...
Lasa Supergenerics Ltd. has forayed into the hormone and steroid API segment for human application with its approval from the Food and Drug Administration authorities to...
Cipla Limited has received final approval for its abbreviated new drug application (ANDA) for Albuterol Sulfate inhalation aerosol 90 mcg (base)/actuation from the USFDA. Cipla’s Albuterol...
Aurobindo Pharma Limited has received the final approval from the US Food & Drug Administration (USFDA) to manufacture and market Fluoxetine tablets, 10 mg and 20...
Anuh Pharma Ltd. has received Certificate of Suitability of European Pharmacopeia (CEP) for Ambroxol Hydrochloride (HCL) for supply to European Union (EU) market.
Dr. Reddy’s Laboratories Ltd. has now received the Establishment Inspection Report (EIR) from US FDA for its formulations manufacturing plant (Vizag SEZ Plant I – PTO...
Sanofi would spin off a new company that will create the active chemical ingredients for drugs, expanding into a market currently dominated by firms in China...
The US Food and Drug Administration has reopened its investigation of Aurobindo Pharma’s Unit-4 manufacturing facility, days after the regulator had announced that it had recommended...
Aurobindo Pharma Ltd has announced in reference to the USFDA inspection of Unit IV, a general injectable formulation manufacturing facility of the company, and issue of...
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