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Lorem ipsum is a dummy or placeholder text commonly used in graphic design, publishing, and web development to fill empty spaces in a layout that does not yet have content.

Lorem ipsum is a dummy or placeholder text commonly used in graphic design, publishing, and web development to fill empty spaces in a layout that does not yet have content.

Lorem ipsum is a dummy or placeholder text commonly used in graphic design, publishing, and web development to fill empty spaces in a layout that does not yet have content.

Wriggling critters armed with enzymes can break down plastics that would otherwise take decades, or even centuries to degrade. At first glance there's nothing particularly remarkable about waxworms. The larval form of wax moths, these pale wriggling grubs feed on...

A WHO-Listed Authority (WLA) is a National Regulatory Authority (NRA) that is recognised as meeting WHO and other internationally recognized regulatory standards and practices. The WLA listing of an NRA by WHO is based on an established global benchmarking and...

Vamorolone is a synthetic corticosteroid approved by USFDA for the treatment of Duchenne Muscular Dystrophy (DMD). DMD is a rare inherited X-chromosome-linked disease manifested as progressive muscle degeneration and weakness, due to a lack of muscle protein called dystrophin. FDA...

USFDA 483 issued to UCB Farchim SA, Switzerland site (FEI 3005023799) is published by FDA. The site was inspected by USFDA investigator Arsen Karapetyan in June / July 2023 and resulted in issuance of FDA Form 483 with four observations....

FDA uses Remote Regulatory Assessments (RRAs) to assess compliance of facility with applicable laws and regulations. If a program office determines that an inspection of a facility is not necessary, feasible, or practical, FDA may instead conduct an RRA. RRA...

Panacea Biotec, Baddi facility was inspected by USFDA in Oct 2023- investigators Sandra A Boyd and Muna Algharibeh - resulting in issuance of Form 483 with 9 observations. The 483 observations highlight inadequate aseptic operations and controls, inadequate laboratory controls...

Nectar Lifesciences was issued an Untitled letter (UL) by USFDA in Sep 23 citing deficiencies in sterile processes, sterile facility and facility monitoring. The untitled letter follows deficiencies observed during an FDA inspection at Nectar Baddi (india) facility during March...

Baxter initiated recall of one lot of Doxil (doxorubicin hydrochloride liposome injection) in U.S due to exposure of product to temperature exceeding labelled storage conditions during transport. Labelled storage conditions for DOXIL is at 2°C- 8°C. Doxil liposomal infusion is...

Spectrum Laboratories Inc, New Jersey, USA (FEI 2246824) was inspected by FDA investigators Sayyem H Akbar & Barbara Wilimczyk Marci in February 2023. The inspection revealed several fundamental GMP compliance issues. Major observations included 1) Inadequate design, qualification, monitoring, cleaning...

In a communique Biocon stated USFDA has categorised inspection classification for Biocon Malaysia as OAI (Official Action Indicated). Biocon Malaysia was inspected by USFDA in July 2023 resulting in USFDA 483 with eight observations on GMP violations. The observations included...

Velsipity (etrasimod) is an oral, once-daily, 2mg dose medication for adults with moderately to severely Active Ulcerative Colitis (UC). UC is a chronic condition, symptoms of UC can include chronic diarrhea with blood and mucus, abdominal pain, and urgency. As...

In a company announcement, Biocon informed that it has received a CR (Complete response) letter for its biosimilar version of insulin Aspart. The CRL references requirement of satisfactory resolution of deficiencies observed during the August 2022 PAI (pre approval inspection)...

In an Interview to CNBCTV18 during visit to India, USFDA Commissioner touched on different topics concerning the Pharma Industry. On inspections Dr.Califf said there will be more unannounced inspections; “if you always observe good practices it shouldn’t matter when an...

The Section 5200.14 of the Manual of Policies and Procedures (MAPP), Filing Review of Abbreviated New Drug Applications is revised. FDA evaluates each ANDA to determine whether an ANDA is substantially complete application and can be received. The MAPP 5200.14...

Hospira recalled in US one lot of 4.2% Sodium bicarbonate injection and one lot each of 1% and 2% Lidocaine HCl injections for potential presence of glass particulate matter. Potential complications of particulate matter in the injections include inflammation of...

USFDA announced it has awarded 10 new clinical trial studies through Orphan Products Grants Program to support the development of medical products for rare diseases. The grants provide more than $27 million of funding to clinical researchers over the next...

The electronic platform for processing Prequalification Information of Medicines – ePQs will enable manufacturers, National Regulatory Agencies and other stakeholders lodge applications for products, documents, receive notifications. The ePQs allows applicants to submit electronic Common Technical Document (eCTD) dossiers.  Through...

SCYNEXIS issued the recall of 2 lots of BREXAFEMME (ibrexafungerp tablets) due to Potential for cross contamination with a non-antibacterial ßlactam ((beta lactam)  drug substance. SCYNEXIS became aware of the cross contamination risk during review of manufacturing equipment and cleaning...

Fabre-Kramer Pharmaceuticals Inc. (Fabre-Kramer), a biopharmaceutical company announced approval of Exxua™ (gepirone hydrochloride extended-release tablets) a new class of antidepressant. The approval comes after years of review over efficacy concerns between FDA and the drug’s sponsors. Announcement

Florida based  VistaPharm LLC is recalling in US one lot of ulcer treatment drug Sucralfate Oral Suspension due to Bacillus Cereus Microbial Contamination. The microbial contamination of the oral suspension has a risk of disseminated, life threatening infections such as...

In the guidance FDA describes use of alternative tools to assess manufacturing facilities identified in NDA, ANDA, or a BLA. FDA conducts PAI (Preapproval) or a PLI (Prelicense) to ensure facility can perform manufacturing in conformance to the cGMP requirements...

  FDA has raised concerns about therapeutic equivalence of Tacrolimus capsules of Accord Healthcare to brand name drug Prograf (tacrolimus) oral capsules. Tacrolimus is indicated for the prevention of organ rejection in patients receiving kidney, liver, or heart transplants. FDA...

Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL is indicated for the prophylaxis of organ rejection in kidney, liver, and heart transplants. The recall is due to crystal formation observed in some bottles of the drug. Crystallization of cyclosporine...

Abbot recalls all batches of Digene Gel of all flavours (Mint, Orange, Mix fruit flavours) in India. The recall follows a customer complaint about a bottle of Digene Gel which was white in colour, and with bitter taste and pungent...

USFDA has eliminated the REMS for Lotronex (alosetron hydrochloride) and approved generics. Alosetron hydrochloride is a drug used to treat severe diarrhea-predominant irritable bowel syndrome (IBS-D) in women. FDA has determined the Risk Evaluation and Mitigation Strategies (REMS) programs for...

USFDA has announced funding opportunity for FDA Orphan Products Clinical Trials Grant Program. The deadline for submission of applications is October 24, 2023. The grants are available to any foreign or domestic entity. The grants are provided for clinical trials...

Bottles of Digoxin Tablets, USP 0.125mg are incorrectly labelled and contain Digoxin Tablets USP, 0.25mg Tablets. Bottles of Digoxin Tablets USP, 0.25mg are incorrectly labelled and contain Digoxin Tablets USP, 0.125mg. The mix-up in labels can cause either overdosing or...

Flunixin meglumine is a potent, non-narcotic, nonsteroidal, analgesic agent with anti-inflammatory and antipyretic activity. It is approved in the US only for intravenous use in beef and dairy cattle, for intravenous and intramuscular use in horses and for intramuscular use...

As per the GDUFA III commitment letter, USFDA has issued a draft guidance for facilities to request a Post Warning Letter Meeting. It is a meeting with FDA regarding the facility’s ongoing remediation efforts of deficiencies identified in a Warning...

The USFDA Warning letter to K. C. Pharmaceuticals issued in August 2023, following inspection at the California facility (FEI 2026940) in Jan & Feb 2023. The Warning letter cites inadequate measures to prevent microbial contamination in aseptic lines - smoke...

In a Class III recall in US, Alembic recalled 82400 bottles of Tobramycin 0.3%, Ophthalmic Solution in July 2023 for failed impurities / degradation specifications. Alembic Tobramycin ophthalmic solution is a sterile topical ophthalmic antibiotic formulation for topical therapy of...

Rufinamide tablets are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS). Aurobindo had received USFDA approval for Rufinamide tablets in June 2023

Biocon Malaysia was inspected by USFDA Investigators Eileen A. Liu, Patty P. Kaewussdangkul, Daniel Lahar, Rong Guo in July 2023. Following the inspection Biocon was issued USFDA 483 with eight observations Procedures and practices of aseptic area operators in Grade...

Several manufacturers of OTC drug products including mouthwash, toothpaste, topical analgesics, Sunscreen products, Hand Sanitizers and capsules were issued Warning letters for failure to test contaminants Diethylene Glycol (DEG), Ethylene Glycol in input components. The Firms failed to demonstrate that...

USFDA: Recommended Acceptable Intake Limits for Nitrosamine Drug Substance[1]Related Impurities (NDSRIs) – Guidance for Industry The USFDA guidance gives a framework for predicting the mutagenic and carcinogenic potential of NDSRIs and recommend acceptable intakes (AI). NDSRIs share structural similarity to...

Zurzuvae (zuranolone), the first oral medication to treat postpartum depression (PPD) in adults. PPD is a major depressive episode that typically occurs after childbirth. Until now, treatment for PPD was only available as an IV injection to be given in a...

The GDUFA fee rates show steepest increase for DMF by 21% to $94,682 from $78,293. ANDA Fee go up by 5% to $2,52,453, Foreign API Facility fee goes up 5.6% to $55,464 and Foreign FDF Facility is up by 3.2%...

Related Links Warning letter Intas Warning letter Centaur Warning letter Medgel Warning letter Baxter Intas Warning letter cites serious Data integrity issues, deficient Laboratory controls, Document controls and Quality and Management oversight, Baxter is cited for deficiencies in Cleaning and...

Intas facility was inspected by FDA investigators Jose E Melendez, Justin A Boyd, Pratik S Upadhyay resulting in a 36-page USFDA 483 with 11 observations. Warning letter was an expected outcome after the critical observations in the 483 and FDA...

Lupin recalls 4179 boxes of Tydemy. Tydemy is Drospirenone, Ethinyl Estradiol & Levomefolate Calcium Tablets 3.0/0.03/0.451mg & 0.451mg, 28 tablets in 1 blister and each blister in a pouch. The recall is initiated due to failed impurities and out of...

Lupin had received Warning letter in November 2017, citing cGMP deficiencies at facilities in Goa and Pithampur (Unit 2), Indore India. (Warning Letter) The Goa plant was cited for: Lapses in OOS investigation-An API batch, OOS for Assay, was retested...

Tarsus Pharmaceuticals Inc., in a statement announced FDA approval of Lotilaner ophthalmology solution 0.25% (XDEMVY™). XDEMVY is an ectoparasiticide (anti-parasitic) indicated for the treatment of Demodex blepharitis. The Lotilaner ophthalmic solution is the first FDA approved treatment for Demodex blepharitis....

Verrica Pharmaceuticals Inc. is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. In a statement, Ted White, Verrica’s President and Chief Executive Officer  said “We are proud to bring patients and caregivers the first FDA-approved treatment...

EMA updates Q&A document on N-Nitrosamines. In the Rev 16 (dated 7 July 2023) limits of N-Nitrosamines in medicinal product is updated, introduces the Carcinogenic Potency Categorization Approach (CPCA) for N-Nitrosamines. For N-nitrosamines without sufficient substance specific data the Carcinogenic...

Centaur Pharmaceuticals, India issued Warning letter by USFDA. The Warning letter dated 5 June 2023 was issued following the inspection at the Ambernath, Mumbai site (FEI 3003973520) in November 2022, for deviations in manufacture of active pharmaceutical ingredients (APIs) and...

EMA, the European Commission (EC) and the Heads of Medicines Agencies (HMA) are phasing out the extraordinary COVID-19 regulatory flexibilities put in place during the COVID-19 pandemic. The extraordinary regulatory flexibilities covered different areas, including marketing authorisation and related regulatory...

Catalent USFDA 483 /Bloomington (FEI :3005949964)/ Inspection Dates: May 4-12, 2023 / Inspectors: Wayne Scifert, Hyung-yul Lee, Esther C.Broner Observation 1: In the aseptic area, procedures and processes are not followed /established: Poor aseptic practices by technicians in sanitising gloved...

Accord USA has initiated recall of multiple lots of Atropine Sulfate, USP 8 mg per 20 mL injection & Bivalirudin for Injection 250 mg, manufactured by Intas Ahmedabad, for presence of particulate matter, fibers. An USFDA inspection in May 2023...

Failure to thoroughly review unexplained discrepancies. Out of specification results on multiple batches of tablets were invalidated based on inconclusive hypothesis In an OOS of a batch of tablets for dissolution test at 9 month long term stability condition, no...

Batch records do not include complete instructions and records Manual visual inspection records of parental line manipulated to record values just below the limits for black particles, white particles, glass particles. Two pattern of manipulations – 1) removing the black,...

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