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 mg and 500 mg,…Read More
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 such as multiple sclerosis…Read More
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 inspection as voluntary action…Read More
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 manufacturing site located at…Read More
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 percent. The approved ANDA…Read More
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 manufacture Progesterone, a steroid…Read More
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 Sulfate inhalation aerosol 90…Read More
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 mg. Fluoxetine tablets are…Read More
Ameri Holdings, Inc. has entered into an amalgamation agreement with Jay Pharma Inc., a Canadian company dedicated to developing innovative, evidence-based cannabinoid products, and combination therapies to address unmet needs…Read More
Sun Pharmaceutical Industries Ltd. has entered into exclusive licensing and supply agreements with Rockwell Medical Inc., to commercialize Rockwell’s Triferic, a proprietary iron-replacement and hemoglobin-maintenance drug, for treating anemia in…Read More
Glenmark Pharmaceuticals Ltd. plans to raise up to USD 200 million through dollar-denominated bonds to refinance debt. Proceeds from the bond sale will be used to refinance existing debt raised…Read More
Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Vilazodone Hydrochloride tablets, 10 mg, 20 mg, and 40…Read More
Aleor Dermaceuticals Ltd. (Aleor), a 60:40 joint venture between Alembic Pharmaceuticals Ltd. (Alembic) and Orbicular Pharmaceutical Technologies Pvt. Ltd. (Orbicular), has completed United States Food and Drug Administration (USFDA) inspection…Read More
The drug pricing regulator has allowed two Mumbai-based pharma majors – Cipla and Glenmark – to have an enhanced pricing for two of their respiratory (inhaler) products on grounds that…Read More
ChrysCapital has exited mid-size drug firm IPCA Labs, offloading its entire stake to 10 mutual funds, for around Rs 560 crore. The PE firm offloaded its 4 percent stake in…Read More
