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Gland Pharma Receives Establishment Inspection Report from USFDA for Goa Facility
Gland Pharma Limited (Gland Pharma), a leading global generic and specialty pharmaceutical company, today announced that it has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its Goa facility.
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Gland Pharma signs exclusive licensing agreement with Lupin for commercializing novel biosimilar Pegfilgrastim in India
Gland Pharma Limited (Gland Pharma), a leading global generic and specialty pharmaceutical company, today announced that it has entered into an exclusive licensing agreement with Lupin Limited (Lupin) for commercializing Pegfilgrastim biosimilar in India.
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Gland Pharma receives approval from USFDA for generic version of Pulmicort Respules (budesonide inhalation suspension)
Gland Pharma Limited (Gland Pharma), a leading global generic and specialty pharmaceutical company, today announced that it has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Budesonide Inhalation Suspension USP, 0.25 mg/2 mL and 0.5 mg/2 mL (equivalent to Budesonide 0.125 mg/mL and 0.25 mg/mL, respectively) generic version of Pulmicort Respules.
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Gland Pharma's Q2 Profit Rises 11% to Rs 286 Crore
Pharmaceutical company Gland Pharma on Monday reported a consolidated net profit of Rs 286.19 crore for the quarter ended September 30, 2022, a growth of 11.06 per cent compared to the same period of the previous fiscal year.
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Gland Pharma to Acquire Cenexi for Rs 1,400 Crore
Gland Pharma on Monday announced that it will acquire Cenexi, a leading sterile injectables contract development and manufacturing organization (CDMO), for Rs 1,400 crore.
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Gland Pharma gets nod for 4 ANDAs
Gland Pharma, a Hyderabad-based pharmaceutical company, has received tentative approval from the US Food and Drug Administration (USFDA) for four abbreviated new drug applications (ANDAs).
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Gland Pharma launches new product in India
Gland Pharma, a Hyderabad-based pharmaceutical company, has launched a new product in India called G-Protect. The product is a combination of two drugs, azithromycin and co-amoxiclav, and is used to treat bacterial infections.
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Gland Pharma receives USFDA approval for new drug
Gland Pharma, a Hyderabad-based pharmaceutical company, has received approval from the US Food and Drug Administration (USFDA) for a new drug called G-Lyte. The drug is used to treat dehydration.
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Gland Pharma receives US FDA approval for generic version of Famotidine injection
The approval is for a sterile liquid-filled pre-filled syringe of Famotidine injection, 20 mg/2 mL (equivalent to 10 mg/mL base). Famotidine injection is indicated for the treatment of gastroesophageal reflux disease (GERD), and for the prevention of stress-induced gastric bleeding.
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Gland Pharma launches generic version of Pegfilgrastim in US
The product is a biosimilar version of Amgen's Neulasta, used for reducing the risk of infection in people receiving certain types of chemotherapy.
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Gland Pharma gets US FDA approval for generic version of Ciprofloxacin injection
The approval is for 200 mg/100 mL and 400 mg/200 mL presentations in single-dose vials. Ciprofloxacin injection is a broad-spectrum antibiotic indicated for the treatment of various bacterial infections.
