Asian Oilfield Services’ wholly owned subsidiary — Asian Oilfield & Energy Services DMCC, Dubai (Asian DMCC) has received a binding Letter of Intent (LOI) from Amni International Petroleum Development OML 52 Company (Amni) to commence engineering and project management work for upgrade of Amni’s existing production facility under the forthcoming project contract of EPCC. The … Read more
Unichem Laboratories has received Establishment Inspection Reports (EIR) from the US Food and Drug Administration (USFDA) indicating closure of inspections at both the API manufacturing facilities located at Pithampur and Roha. The inspection at Pithampur was conducted by the USFDA from July 23, 2018 to July 27, 2018, while the inspection at Roha was conducted … Read more
Lupin Neurosciences, a specialty pharma division of Lupin has announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion recommending the marketing authorization of NaMusclaim (mexiletine hydrochloride) for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders. … Read more
Strides Pharma Science’s step‐down wholly owned subsidiary, Strides Pharma Global Pte, has received approval for Gabapentin Capsules USP, 100 mg, 300 mg, and 400 mg from the United States Food and Drug Administration (USFDA). Gabapentin Capsules is a generic version of Neurontin Capsules of Pfizer. The product received approval in the first cycle of review … Read more
Zydus Cadila has received tentative approval from the US Food and Drug Administration (USFDA) to market Colchicine Tablets USP (US RLD – ColcyrsTM), 0.6 mg. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. This medication is used to prevent or treat attacks of gout (also called gouty arthritis). This condition … Read more
Sang Froid labs India has received license to sell, stock or exhibit or offer for sale, or distribute by Wholesale drugs specified in Schedules C and C(1) [excluding those specified In schedule x] as per the Drugs and Cosmetics Rules, 1945 in form 21B and the company has received license to sell, stock or exhibit … Read more
Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Alogliptin Tablets, 6.25 mg, 12.5 mg and 25mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), NESINA Tablets, 6.25 mg, 12.5 mg and 25mg of Takeda Pharms USA. … Read more
