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Glenmark Pharma’s arm receives USFDA’s approval for Fulvestrant Injection

Glenmark Pharmaceuticals’ subsidiary — Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Fulvestrant Injection, 250 mg/5 mL (50 mg/mL), a generic version of Faslodex Injection, 250 mg/5 mL (50 mg/mL), of AstraZeneca Pharmaceuticals LP. According to IQVIA sales data for the 12 month period ending June 2019, the ... Read More »

Granules India’s arm receives USFDA’s approval for Amphetamine Sulfate Tablets

Granules India’s wholly owned foreign subsidiary — Granules Pharmaceuticals, Inc. has received approval for the Abbreviated New Drug Application (ANDA) from US Food & Drug Administration (USFDA) for Amphetamine Sulfate Tablets USP 5 mg and 10 mg. It is bioequivalent to the reference listed drug product (RLD), Evekeo Tablets, 5 mg and 10 mg, of Arbor Pharmaceuticals, LLC. Amphetamine Sulfate ... Read More »

USFDA completes inspection at Granules India’s Hyderabad facility

US Food and Drug Administration (USFDA) has completed inspection at Granules India’s Bonthapally facility located at Hyderabad in the state of Telangana. The inspection was conducted from July 22, 2019 to July 26, 2019. The inspection concluded with one 483 observation which is procedural in nature. Bonthapally facility is one of the world’s largest single site Paracetamol API manufacturing plant ... Read More »

USFDA completes inspection at Neuland Laboratories’ Hyderabad facility

The United States Food and Drug Administration (USFDA) has completed inspection Neuland Laboratories’ Unit 1 manufacturing facility at Bonthapally, Hyderabad. The inspection was conducted from June 17 to 21, 2019. The inspection has been completed with five observations given under form 483. The company has already initiated corrective and preventive actions for the observations and is confident of satisfying the ... Read More »

FDC receives USFDA’s approval for Dorzolamide and Timolol Ophthalmic Solution

  FDC has been granted ANDA approval by United States Food and Drug Administration (USFDA), for Dorzolamide and Timolol Ophthalmic Solution USP 22.3mg/6.83mg per ml, a generic version of Cosopt of Oak Pharmaceuticals Inc. FDC is engaged in manufacture of specialized formulations, and oral rehydration salts (ORS). WhatsApp Facebook Twitter Download Udaipur Kiran App to read Latest News Today Read More »

USFDA completes inspection at Divi’s Laboratories’ Unit-II facility in Chippada

US Food and Drug Administration (USFDA) has completed inspection at Divi’s Laboratories’ Unit-II at village Chippada, Bheemunipatnam District in the state of Andhra Pradesh (AP). The inspection was conducted from June 10 to 15, 2019. This was a general CGMP inspection by the US-FDA. The inspection has been concluded with no 483 observations. Divis Laboratories focussed on developing new processes ... Read More »

Alembic Pharmaceuticals gets USFDA approval for Solifenacin Succinate Tablets

Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Solifenacin Succinate Tablets, 5 mg and 10 mg. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Vesicare Tablets, 5 mg and 10 mg, of Astellas Pharma US, Inc. Solifenacin Succinate Tablet is a muscarinic antagonist indicated ... Read More »

Panacea Biotec receives USFDA’s approval for Azacitidine Injection

Panacea Biotec has received United States Food & Drug Administration (USFDA) approval for manufacture and supply of Azacitidine Injection, 100 mg/vial, for the US market. Panacea Biotec’s state-of-the-art pharmaceutical formulation facility at Baddi is already approved by National Regulatory Authority (NRA) of India and USFDA for other oral solids and injectable products. Azacitidine is a chemotherapy drug used to treat ... Read More »

USFDA conducts inspection at Cipla’s Indore facility

The United States Food and Drug Administration (USFDA) has conducted a post-approval inspection at Cipla’s Indore facility from May 13 – 17, 2019. The inspection ended with zero observations. Cipla is a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients. The company’s portfolio includes over 1500 products across wide range ... Read More »

USFDA classifies inspection concluded at Aurobindo Pharma’s API facilities

Aurobindo Pharma has received letters from the US Food and Drug Administration (USFDA) classifying the inspections concluded at its API facilities of Unit I and XI and intermediates facility of unit IX in February 2019 as Official Action Indicated (OAI). The company has already submitted its initial response to USFDA. The company is sending further updates on the committed corrective ... Read More »

USFDA completes inspection of Lupin’s Aurangabad facility

The United States Food and Drug Administration (USFDA) has completed inspection at Lupin’s Aurangabad manufacturing facility. The inspection was carried out from May 6 to May 15, 2019. The inspection at the Aurangabad facility closed with three observations. The company is confident of addressing them satisfactorily. Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range ... Read More »

Lupin gains on receiving EIR from USFDA

Lupin is currently trading at Rs. 805.20, up by 3.85 points or 0.48% from its previous closing of Rs. 801.35 on the BSE. The scrip opened at Rs. 785.10 and has touched a high and low of Rs. 809.20 and Rs. 785.10 respectively. So far 72773 shares were traded on the counter. The BSE group ‘A’ stock of face value ... Read More »

Natco Pharma’s marketing partner gets USFDA’s nod for Nitroglycerin Sublingual Tablets

Natco Pharma’s marketing partner Alvogen has received the final approval of Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (USFDA) for Nitroglycerin Sublingual Tablets USP, 0.3 mg, 0.4 mg, and 0.6 mg. Nitroglycerin sublingual tablets are used to treat episodes of angina (chest pain) in people who have coronary artery disease (narrowing of the blood vessels ... Read More »

Lupin in alliance with Natco receives USFDA approval for Bosentan Tablets

Lupin in alliance with Natco Pharma (Natco) has received approval for Bosentan Tablets, 62.5 mg and 125 mg, from the United States Food and Drug Administration (USFDA) to market a generic version of Actelion Pharmaceuticals’ Tracleer Tablets, 62.5 mg and 125 mg. The company and Natco’s Bosentan Tablets, 62.5 mg and 125 mg, is the generic version of Actelion Pharmaceuticals’ ... Read More »

Zydus Cadila receives USFDA’s approval for Leflunomide Tablets

Zydus Cadila has received the final approval from the United States Food & Drug Administration (USFDA) to market Leflunomide Tablets USP (US RLD-Arava Tablets), 10 mg and 20 mg. It will be manufactured at the group’s formulations manufacturing facility at Baddi. This medication is used to treat rheumatoid arthritis, a condition affecting multiple small and large joints of the body. ... Read More »

Shilpa Medicare receives USFDA’s approval for Busulfan Injection

Mumbai : Shilpa Medicare has received US Food and Drug Administration’s (USFDA) approval for its ANDA, Busulfan Injection, 60 mg/10 ml. Busulfan Injection, 60 mg/10 ml is a generic equivalent of reference listed drug (RLD), Busulfex Injection, 60 mg/10 ml, used in the treatment of patients with chronic myelogenous leukemia as recommended in the label approved by USFDA. According to ... Read More »

Alembic Pharma gets USFDA’s nod for Bimatoprost Ophthalmic Solution

Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Bimatoprost Ophthalmic Solution, 0.03%. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Lumigan, 0.03% of Allergan Sales, LLC (Allergan). Bimatoprost Ophthalmic Solution, 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open ... Read More »

USFDA completes inspection of Wockhardt’s Bioequivalence Centre

The United States Food & Drug Administration (USFDA) has carried out inspection of Wockhardt’s Bioequivalence Centre located at R&D Centre, Aurangabad in the state of Maharashtra. During which Bioequivalence studies of Tamsulosin 0.4mg capsules and Metoprolol Tartrate 200mg ER tablets were audited. At the end of inspection, there was nil observation (i.e. zero 483 observation), signifying that best practices were ... Read More »

USFDA concludes inspection at Cadila Healthcare’s manufacturing facility in Ahmedabad

United States Food and Drug Administration (USFDA) has concluded inspection at Cadila Healthcare’s manufacturing facility located at Pharmez in Ahmedabad with one observation. The inspection was conducted from March 25, 2019 to April 02, 2019. The inspection includes product specific pre-approval and post approval inspections and a GMP inspection. Cadila Healthcare is an India-based pharmaceutical company. The company’s subsidiaries include ... Read More »

Cadila Healthcare’s arm gets one observation for Ahmedabad plant from USFDA

The US Food and Drug Administration (USFDA) has conducted a Pre-Approval Inspection (PAI) for Doxorubicin Liposomal, a complex oncological injectable at Alidac Pharmaceuticals, the injectable onco manufacturing facility, located at Pharmez, Ahmedabad from March 18 to 26, 2019. The inspection concluded with one observation. Alidac Pharmaceuticals is a 100% subsidiary of Cadila Healthcare. The company is addressing these observations and ... Read More »

USFDA classifies Lupin’s Somerset facility as ‘Official Action Indicated’

Lupin’s subsidiary — Novel Laboratories’ Somerset facility has been cautioned by the United States Food and Drug Administration (USFDA) that it may be subject to regulatory or administrative action and that it may withhold approval of any pending applications or supplements in which this facility is listed. The US Food and Drug Administration (USFDA) had conducted inspection at Somerset (New ... Read More »

Glenmark’s arm gets USFDA’s final approval for Clindamycin, Benzoyl Peroxide Gel

Glenmark Pharmaceuticals’ subsidiary — Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Clindamycin and Benzoyl Peroxide Gel, 1%/5%, a generic version of BenzaClin Gel, 1%/5%, of Valeant Bermuda. According to IQVIA sales data for the 12 month period ending January 2019, the BenzaClin Gel, 1%/5% market achieved annual ... Read More »

Zydus Cadila receives final USFDA’s nod for Atenolol and Chlorthalidone Tablets

Zydus Cadila has received the final approval from the US Food and Drug Administration (USFDA) to market Atenolol and Chlorthalidone Tablets USP (US RLD-Tenoretic), 50 mg/25 mg and 100 mg/25 mg. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. This medication is used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent ... Read More »

USFDA concludes inspection at Unichem Laboratories’ Ghaziabad facility

United States Food and Drug Administration (USFDA) has successfully concluded the inspection at Unichem Laboratories’ Ghaziabad facility. The regulator had conducted inspection at the company’s facility from March 05, 2019 to March 08, 2019. The inspection was concluded without any FDA form 483 issued. Unichem Laboratories is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket ... Read More »

Zydus Cadila gets USFDA’s final nod for Triamterene, Hydrochlorothiazide Capsules

Zydus Cadila has received the final approval from the United States Food and Drug Administration (USFDA) to market Triamterene and Hydrochlorothiazide Capsules USP (US RLD-DYAZIDE), 37.5 mg/25 mg. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. The fixed dose combination of Triamterene and Hydrochlorothiazide is indicated for the treatment of hypertension or edema in patients ... Read More »

Laurus Labs gets EIR from USFDA for unit 6 in Andhra Pradesh

Laurus Labs has received an Establishment Inspection Report (EIR) from US Food and Drug Administration (USFDA) for its Unit 6 on February 2, 2019. The manufacturing unit 6 was inspected by the regulatory agency in the month of November 2018 and is located at APSEZ, Atchutapuram, Visakhapatnam in the state of Andhra Pradesh. Laurus Labs is a leading research and ... Read More »

USFDA conducts inspection at Alkem Laboratories’ facility at Daman

US Food and Drug Administration (USFDA) has conducted an inspection at Alkem Laboratories’ manufacturing facility located at Daman in the state of Gujarat, from January 14, 2019 to January 18, 2019. After the inspection there were no observation found. Alkem Laboratories is a leading Indian pharmaceutical company with global operations, engaged in the development, manufacture and sale of pharmaceutical and ... 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 »

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 »

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 »