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Tag Archives: approval

Zydus Wellness gets approval to raise Rs 1,500 crore via NCDs

Zydus Wellness has received approval to raise funds of aggregate nominal value up to Rs 1,500 crore through issuance of rated, secured, listed, redeemable, Non-Convertible Debentures (NCDs) each having a face value of Rs 10 lakh on private placement basis. The Board of Directors of the Company at its meeting held on January 11, 2019 has approved the same. Zydus ... Read More »

Tata Steel BSL gets approval to raise funds via NCRPS

Tata Steel BSL has received approval to raise funds through issuance of Non-Convertible Redeemable Preference Shares (NCRPS) to Tata Steel, on a private placement basis for an amount not exceeding to Rs 12,000 crore. The Board of Directors of the Company at its meeting held on January 09, 2019 has approved the same. Tata Steel BSL formerly known as Bhushan ... Read More »

Zydus receives approval from USFDA for Clindamycin Phosphate and Benzoyl Peroxide Gel

Zydus Cadila has received the final approval from the USFDA to market Clindamycin Phosphate and Benzoyl Peroxide Gel, (US RLD-DUAC Gel), 1.2%/5%. It will be manufactured at the group’s Topical manufacturing facility at Ahmedabad. This combination medication is used to treat a certain type of acne (inflammatory acne vulgaris). It helps to decrease the number of acne pimples. Clindamycin is ... Read More »

NTPC gets investment approval for Solar PV Project

NTPC has received investment approval for Bilhaur Solar PV Project of 140 MW capacity and Auraiya Solar PV Project of 20 MW capacity. Earlier on October 10, 2018, the company participated for 160 MW Solar capacities in Uttar Pradesh and has won the entire capacity bid by it, comprising 140 MW at a levelised tariff of Rs 3.17/unit and 20 ... Read More »

Glenmark Pharma receives ANDA approval for Fluocinolone Acetonide Oil

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Fluocinolone Acetonide Oil, 0.01% (Ear Drops), a generic version of DermOtic Oil, 0.01% (Ear Drops), of Hill Dermaceuticals, Inc. According to IQVIA sales data for the 12 month period ending October 2018, the DermaOtic Oil, 0.01% (Ear Drops) market achieved ... Read More »

Relaxo Footwears gets NCLT approval for scheme of amalgamation

Relaxo Footwears has received an approval of the National Company Law Tribunal (NCLT), Principal Bench, New Delhi, to the Scheme of Amalgamation between Marvel Polymers, Relaxo Rubber and the company and their respective shareholders and creditors. Relaxo Footwears is engaged in the manufacturing and trading of footwear and related products. The principal activity of the company is the manufacture of ... Read More »

Ravalgaon Sugar Farm receives approval for sale of assets

Ravalgaon Sugar Farm has received approval from its board for sale of land measuring 1,118 sq meters along with staff quarters (built up area 330 Sq meters) on an as is where is basis for Rs 28 lakh (all inclusive), sale of candy sugar plant and machinery on an as is where is basis for Rs 75 lakh plus taxes ... Read More »

Alembic Pharma receives USFDA approval for Candesartan Cilexetil tablets

Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Candesartan Cilexetil tablets USP, 4 mg, 8 mg, and 16 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Atacand Tablets, 4 mg, 8 mg, and 16 mg, of ANI Pharmaceuticals, Inc. Candesartan cilexetil tablets ... Read More »

Yes Bank’s arm receives approval to launch two mutual fund schemes

Yes Bank’s wholly owned subsidiary — Yes Asset Management (India) has received the Securities & Exchange Board of India’s (SEBI) approval to launch Yes Liquid Fund and Yes Ultra Short Term Fund. This approval is subsequent to the Reserve Bank of India’s (RBI) approval granted to the Bank to sponsor a Mutual Fund followed by SEBI’s in-principle approval received subsequently. ... Read More »

Aurobindo Pharma expecting first biosimilar approval in US in 12-18 months

Aurobindo Pharma is expecting to receive an approval for its first biosimilar product in the US in the next 12-18 months, while in Europe, the company hopes a green signal by 2022. Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain ... Read More »

Omax Autos gets approval to setup new industrial unit in Uttar Pradesh

Omax Autos has received approval for setting up a new industrial unit for manufacture and supply of ‘Long Member’ at or around Raebareli in the state of Uttar Pradesh. The Board of Directors of the Company at its meeting held on December 03, 2018 has approved the same. The proposed capacity is to be added within 3 years at an ... Read More »

Biocon, Mylan’s joint product Fulphila gets approval in EU

Biocon and Mylan’s jointly developed Fulphila, a biosimilar Pegfilgrastim, has been approved in EU. The European Commission has granted Marketing Authorization for Fulphila to the company’s partner Mylan. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion recommending approval of Fulphila as a biosimilar to Amgen’s Neulasta, which is indicated for the ... Read More »

Alembic Pharmaceuticals receives approval from USFDA for Temazepam Capsules

Alembic Pharmaceuticals has received an approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Temazepam Capsules USP 7.5mg, 15mg, 22.5mg and 40mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Restoril Capsules, 7.5mg, 15mg, 22.5mg and 40mg, of SpecGx LLC. Temazepam Capsules are indicated for short term treatment ... Read More »

Cords Cable gets pre-qualified supplier approval from AAI

Cords Cable Industries has been now approved as a pre-qualified supplier with Airports Authority of India (AAI). This prestigious approval shall now enable Cords Cable industries to offer its approved list of cables towards creating, upgrading, maintaining and managing aviation infrastructure in the country for the projects where AAI is entrusted with Airport Modernisation and Development. This approval is currently ... Read More »

Alembic Pharma’s JV gets approval from USFDA for Lidocaine Ointment

Alembic Pharmaceuticals’ Joint Venture (JV) — Aleor Dermaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Lidocaine Ointment USP, 5%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Xylocaine Ointment, 5%, of AstraZeneca Pharmaceuticals LP (AstraZeneca). Lidocaine Ointment USP, 5% are indicated for production of ... Read More »

Lupin receives USFDA approval for Potassium Chloride for Oral Solution

Lupin has received approval for its Potassium Chloride for Oral Solution USP, 20 mEq from the United States Food and Drug Administration (USFDA) to market a generic version of Pharma Research Software Solution LLC’s Potassium Chloride for Oral Solution, 20 mEq. Lupin’s Potassium Chloride for Oral Solution USP, 20 mEq is the generic version of Pharma Research Software Solution, LLC’s ... Read More »

Glenmark Pharma receives tentative approval from USFDA for Clobetasol Propionate Foam

Glenmark Pharmaceuticals Inc., USA has been granted tentative approval by the United States Food & Drug Administration (USFDA) for Clobetasol Propionate Foam, 0.05% (Emulsion Formulation), a generic version of Olux-E Foam, 0.05%, of Mylan Pharmaceuticals, Inc. According to IQVIA sales data for the 12 month period ending September 2018, the Olux-E Foam, 0.05% market achieved annual sales of around $13.2 ... Read More »

Glenmark Pharma gets final approval from USFDA for Atovaquone Oral Suspension

Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (USFDA) for Atovaquone Oral Suspension USP, 750 mg/5 mL, a generic version of Mepron Oral Suspension, 750 mg/5 mL, of GlaxoSmithKline LLC. According to IQVIA sales data, the Mepron Oral Suspension, 750 mg/5 mL market2 achieved annual sales of around $119.1 million. Glenmark’s ... Read More »

Zydus Cadila receives tentative approval from USFDA for Deferasirox Tablets

Zydus Cadila has received the tentative approval from the United States Food and Drug Administration (USFDA) to market Deferasirox Tablets, 90 mg, 180 mg, and 360 mg (US RLD – Exjade Tablets). It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad in the state of Gujarat. It is used to treat ongoing high levels of iron ... Read More »

Glenmark gets final approval from USFDA for Azelaic Acid Gel

Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (USFDA) for Azelaic Acid Gel, 15%, a generic version of Finacea Gel, 15%, of Leo Pharma A/S. According to IQVIA sales data for the 12 month period ending September 2018, the Finacea Gel, 15% market achieved annual sales of approximately $64.1 million. The ... Read More »

GVK Power gets approval to raise Rs 8,000 crore

GVK Power & Infrastructure (GVKPIL) has received approval from its shareholders to raise funds upto Rs 8,000 crore by disposal, sale, lease, hypothecation, mortgage, charge or otherwise of all or any of the immovable and movable properties of the company. The shareholders of the company at its annual general meeting (AGM) held on November 14, 2018 has approved the same. ... Read More »

Zydus Cadila receives USFDA’s approval for Abacavir & Lamivudine Tablets, Fondaparinux Sodium Injection

Zydus Cadila has received the final approval from the United States Food and Drug Administration (USFDA) to market Abacavir and Lamivudine Tablets USP, 600 mg/300 mg (US RLD- EPZICOM), and Fondaparinux Sodium Injection USP, 2.5 mg/0.5 mL, 5 mg/0.4 mL 7.5 mg/0.6 mL and 10 mg/0.8 mL single-dose (US RLD- ARIXTRA). Abacavir and Lamivudine Tablets are used with other antiretroviral ... Read More »

Bank of Baroda gets approval to raise funds via bonds

Bank of Baroda has received approval to raise funds through issuance of Tier-II Capital Bonds compliant with Basel III Capital Regulations of the Reserve Bank of India for issue size not exceeding Rs 1,500 crore, with a base issue size upto Rs 500 crore and a Green shoe option to retain over-subscription upto Rs 1,000 crore, in single or multiple ... Read More »

Glenmark Pharmaceuticals receives ANDA approval for Teriflunomide Tablets

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Teriflunomide Tablets, 7 mg and 14 mg, a generic version of Aubagio Tablets, 7 mg and 14 mg, of Sanofi-Aventis U.S., LLC. With respect to 180-day generic drug exclusivity, the company was one of the first ANDA applicants to submit ... Read More »

Lupin receives USFDA’s approval for Decitabine for Injection

Lupin has received approval for its Decitabine for Injection, 50 mg/vial, Single-Dose Vial from the United States Food and Drug Administration (USFDA) to market a generic version of Otsuka Pharmaceutical Company’s (Otsuka) Dacogen for Injection, 50 mg/vial, Single-Dose Vial. It is indicated for the treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary ... Read More »

Lupin receives USFDA approval for Budesonide Inhalation Suspension

Lupin has received approval for its Budesonide Inhalation Suspension, 0.5 mg/2 mL Single-Dose Ampules from the United States Food and Drug Administration (USFDA) to market a generic version of AstraZeneca Pharmaceuticals LP’s (AstraZeneca) Pulmicort Respules Inhalation Suspension, 0.5 mg/2 mL. Lupin’s Budesonide Inhalation Suspension, 0.5 mg/2 mL Single-Dose Ampules is the generic version of AstraZeneca’s Pulmicort Respules Inhalation Suspension, 0.5 ... Read More »

Zydus Cadila gets USFDA’s approval for Nystatin and Triamcinolone Acetonide Ointment

Zydus Cadila has received the final approval from the United States Food and Drug Administration (USFDA) to market Nystatin and Triamcinolone Acetonide Ointment USP, (US RLD -Mycolog-II Ointment), 100,000 units/gram and 1 mg/gram. It will be manufactured at the group’s Topical manufacturing facility at Ahmedabad. It is used to treat fungal skin infections. This product contains nystatin, an anti-fungal drug ... Read More »

Cipla gets approval from USFDA for Valganciclovir Tablets

Cipla has received final approval for its Abbreviated New Drug Application (ANDA) for Valganciclovir Tablets 450mg from the United States Food and Drug Administration (USFDA). The company’s Valganciclovir Tablets 450mg is AB-rated generic therapeutic equivalent version of Roche’s Valcyte. It is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for use in the treatment of CMV retinitis in patients ... Read More »

Tata Power receives approval to issue NCDs worth Rs 5,500 crore

Tata Power Company has received approval for issuance in one or more tranches, of noncumulative, redeemable, taxable, listed, rated securities in the form of Non-Convertible Debentures (NCDs) upto an aggregate amount not exceeding Rs 5,500 crore on private placement basis to any persons, entities, bodies corporate, companies, banks, financial institutions and any other categories of eligible investors. The Board of ... Read More »

Glenmark receives USFDA’s final approval for Fluocinolone Acetonide Topical Oil

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil), a generic version of Derma-Smoothe/FS Topical Oil, 0.01% (Scalp Oil), of Hill Dermaceuticals, Inc. According to IQVIA sales data for the 12 month period ending September 2018, the DermaSmoothe/FS Topical Oil, 0.01% (Scalp ... Read More »

Zydus Cadila gets final approval from USFDA for Clobazam Tablets

Zydus Cadila has received the final approval from the US Food and Drug Administration (USFDA) to market Clobazam Tablets, (US RLD-ONFI Tablet), 10 mg and 20 mg. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. Clobazam is used in combination with other medications to treat seizures caused by a paediatric epilepsy syndrome (termed as Lennox-Gastaut ... Read More »

Lupin receives USFDA’s approval for generic Triamcinolone Acetonide Ointment

Lupin has received approval for its Triamcinolone Acetonide Ointment USP, 0.1% from the United States Food and Drug Administration (FDA) to market a generic version of Mylan Pharmaceuticals, Inc.’s (Mylan) Triamcinolone Acetonide Ointment, 0.1%. Lupin’s Triamcinolone Acetonide Ointment USP, 0.1% is the generic version of Mylan’s Triamcinolone Acetonide Ointment, 0.1%. It is indicated for the relief of the inflammatory and ... Read More »

AMJ Land Holdings gets approval for scheme of amalgamation

AMJ Land Holdings has received an approval for scheme of amalgamation of Pudumjee Investment & Finance Company, a wholly owned subsidiary of AMJ Land Holdings, with the company. This is subject to all requisite approvals including sanction by the National Company Law Tribunal. The Board of Directors of the company at its meeting held on October 20, 2018 has approved ... Read More »

Strides’ arm receives USFDA’s approval for Gabapentin Capsules

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 of 10 months under the ... Read More »

Zydus Cadila receives approval from USFDA for Colchicine Tablets

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 is caused by high uric ... Read More »

Zydus Cadila gets final approval from USFDA for Clobetasol Propionate Cream

Zydus Cadila has received the final approval from the US Food and Drug Administration (USFDA) to market Clobetasol Propionate Cream, (USRLD Temovate Cream), 0.05%. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. Clobetasol Propionate is a topical (for the skin) steroid used to treat inflammation and itching caused by a number of skin conditions such ... Read More »

Alembic Pharma receives USFDA’s tentative approval for Alogliptin Tablet

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. Alogliptin Tablets, 6.25 mg, 12.5 ... Read More »

OCL India gets approval for scheme of Amalgamation

OCL India has received an approval from its board for implementation of the scheme of Arrangement and Amalgamation of the company and Dalmia Cement East (DCEL) & other associates into Odisha Cement (ODCL). Post-merger, ODCL shall be renamed as OCL India. The Board of Directors of the company at its meeting held on October 15, 2018 approved the same. OCL ... Read More »

Dr. Reddy’s Lab gets approval for Aspirin, extended-release Dipyridamole Capsules

Dr. Reddy’s Laboratories has received an approval for Aspirin and Extended-Release Dipyridamole Capsules, a therapeutic equivalent generic version of Aggrenox (aspirin and extended-release dipyridamole) Capsules in the United States market from the US Food and Drug Administration (USFDA). The company is working towards launching the product. The Aggrenox brand and generic had US sales of around $183 million MAT for ... Read More »

Glenmark’s arm receives USFDA’s final approval for Hydrocortisone Valerate Cream

Glenmark Pharmaceuticals’ subsidiary — Glenmark Pharmaceuticals Inc, USA has been granted final approval by the United States Food and Drug Administration (USFDA) for Hydrocortisone Valerate Cream USP, 0.2%, a generic version of Westcort Cream, 0.2%, of Sun Pharmaceutical Industries Inc. According to IQVIA sales data for the 12-month period ending August 2018, the Westcort Cream, 0.2% market achieved annual sales ... Read More »

Reliance Capital’s arm gets R3 approval from IRDAI

Reliance Capital’s wholly owned subsidiary — Reliance Health Insurance has received R3 approval from Insurance Regulatory and Development Authority (IRDAI) for its new health insurance business. The new company will commence operations by the December quarter of 2018. Reliance Capital, a part of the Reliance Group, is one of India’s leading private sector financial services companies. It has interests in ... Read More »

Janakpuri West-Kalkaji Mandir metro section gets approval to start passenger services

“The commissioner for metro rail safety has given the mandatory approval for the start of passenger operations for Janakpuri West-Kalkaji Mandir, subject to the fulfillment of certain conditions and stipulations,” a Delhi Metro Rail Corporation official said. The Magenta Line section has 16 stations, including two inter-change stations – Hauz Khas (with Yellow Line) and Janakpuri West (with Blue Line). ... Read More »