Neuland Laboratories Ltd

Banjara Hills, India

Neuland Laboratories Ltd

Banjara Hills, India
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News Article | July 20, 2017
Site: www.businesswire.com

HYDERABAD, India--(BUSINESS WIRE)--Neuland Laboratories Limited (NLL) (NSE: NEULANDLAB; BSE-Scrip Code:524558), a pharmaceutical manufacturer providing active pharmaceutical ingredients (APIs), complex intermediates and custom manufacturing solutions services to customers located in about 80 countries has brought online a fully operational dedicated Process Engineering Lab at its R&D Center. The new lab includes state-of-the-art instrumentation, systems and innovative devices to support operations and safety studies using a QbD approach. "Our new Process Engineering Lab integrates the key attributes of QbD process understanding, process control, and continuous improvement with advanced equipment, Design of Experiments Software, and Design Space methodology, to optimize process design, operations, and productivity," says Saharsh Davuluri, Joint Managing Director at Neuland. Neuland’s new Process Engineering Lab includes a stirred, controlled HEL reaction calorimeter that measures the rate of heat release during reactions. Automated parallel HEL reactors enable a chemist to perform multiple experiments at temperatures ranging from -60 to 225oC. The lab's new Thermal Screening Unit (TSU) indicates the thermal stability of chemicals and safe processing temperatures. Ideal for risk analysis, the TSU uses only 0.5-5 g of sample. "This important addition to our capabilities will better enable Neuland to develop cost-effective procedures and quality products, meet regulatory requirements, improve scale-up efficiency, and accelerate time to market," says Dr. Ravi Ponnaiah, President – Science & Technology. A QbD approach includes three fundamental elements: 1) a clear understanding of the target product profile; 2) determination of critical quality attributes (CQAs) and 3) ensuring that processes and products remain within defined range limits. Continual risk assessment of all aspects of a process, from the quality of the raw materials to the process parameters and their potential effects on CQAs enables continuous improvement of processes and products. A QbD program relies on applying this information to develop a design space and a process control strategy, continually monitoring the process to assess its capabilities, introducing changes to improve product quality, cost, and process efficiency. Neuland Laboratories Limited, established in 1984, is headquartered in Hyderabad, India, with offices in the U.S. and Japan. Neuland produces quality APIs for customers across 80+ countries in more than 10 diverse therapeutic segments. Along with generic drug products, Neuland offers contract and custom manufacturing services for APIs and advanced intermediates. The company has a stellar track record of successful regulatory inspections from the U.S. Food and Drug Administration (FDA, inspected 12 times), PMDA-Japan, EDQM, EMA, KFDA, TGA, ANVISA Brazil and AFSSAPS (France), ISO9001, ISO14001, OHSAS18001 and ISO 27001. Current regulatory filings exceed 650 with 51 USDMFs, 19 CEPs and 5 JDMFs. Neuland has more than 523,000 L of reactor volume.


Patnala S.R.C.M.,Neuland Laboratories Ltd | Patnala S.R.C.M.,Jawaharlal Nehru Technological University | Khagga M.,Jawaharlal Nehru Technological University | Bhavani R.,Village Green | Bhavani V.,Anurag Group of Institutions
Oriental Journal of Chemistry | Year: 2017

The present study describes the preparation of novel salt of Tinidazole (TN) with p-Toluenesulfonic acid (PTSA) that display enhanced solubility and antibacterial activity in Bacillus. The salt was prepared by solvent-drop grinding and characterised by powdered X-Ray diffraction, thermal analysis, Fourier transformation infrared spectroscopy (FT-IR) and polarized microscopy. FT-IR data confirms Tinidazole salt with p-Toluenesulfonic acid (TN-PTSA). Powdered X-ray diffraction and thermal analysis data reveals that both TN and TN-PTSA are crystalline nature. From microscopic photographs of polarized microscopy, crystals of TN-PTSA are rod shape whereas crystals of TN are plate shape. Solubility measurement of TN-PTSA on UV spectrophotometer showed solubility improvement compared with TN by 49.7 times in water. Antibacterial test showed higher activity in TN-PTSA to the Gram-positive bacillus bacteria as compared to the TN. This study demonstrates that TN-PTSA can be a potential substitute to the TN in the treatment of infection with Gram-positive bacillus bacteria. © 2017, Oriental Scientific Publishing Company. All rights reserved.


Patnala S.R.C.M.,Neuland Laboratories Ltd | Patnala S.R.C.M.,Jawaharlal Nehru Technological University | Patnala S.R.C.M.,Village Green | Khagga M.,Jawaharlal Nehru Technological University | Bhavani R.,Village Green
Asian Journal of Chemistry | Year: 2015

Nitazoxanide [2-[(5-nitro-1,3-thiazol-2-yl)carbamoyl]phenyl]ethanoate] is a drug used for antiprotozoal treatment. This drug belongs to biopharmaceutics classification system (II) and presently available in two high oral dosage forms-tablet (500 mg) and oral suspension (100 mg per 5 mL when reconstituted). A monotropically more stable novel polymorphic form (Form II) of nitazoxanide with improved aqueous solubility has been identified and fully characterized by a variety of analytical techniques such as powder X-ray diffraction, differential scanning calorimeter, thermogravimetric analysis, Karl Fischer titration, infrared spectroscopy, solution state nuclear magnetic resonance, polarized microscopy and high performance liquid chromatography techniques. Aqueous solubility of Form II is increased by 2.76 folds. Form II is obtained from less toxic and environment friendly Class III organic solvent ethanol.


Patent
NEULAND LABORATORIES Ltd | Date: 2013-04-08

An improved process for preparation of Olanzapine pamoate monohydrate from Olanzpaine is disclosed which comprises mixing at room temperature a solution of olanzapine prepared in water in presence of an acid, with a solution of pamoic acid prepared in water in presence of a base; stirring and maintaining the reaction mixture for a sufficient time till precipitation of solid and drying the solid to obtain olazapine pamoate monohydrate.


Patent
NEULAND LABORATORIES Ltd | Date: 2013-04-08

The present invention provides a process for the preparation of sugammadex sodium involving the step of: reacting 6-perdeoxy-6-per-halo-gamma-cyclodextrin with 3-mercapto propionic acid in the presence of alkali metal alkoxide in an organic solvents. The invention also provides a process for purifying the sugammadex or its pharmaceutically acceptable salts using water and organic solvents.


Lahoti A.M.,Neuland Laboratories Ltd. | Ravi P.,Neuland Laboratories Ltd. | Kumar N.P.,Neuland Laboratories Ltd. | Innareddy V.,Neuland Laboratories Ltd. | And 4 more authors.
Pharmaceutical Technology | Year: 2015

Febuxostat is a novel, non-purine, selective inhibitor of xanthine oxidase for hyperuricemia in patients with gout. It is the first promising substitute for allopurinol in 40 years. Various synthetic routes to febuxostat, as well as polymorphic forms and impurities of the drug, are reported in the literature. The authors have also identified several impurities that result from the synthesis of febuxostat. This article describes the identification and control of all isomeric, carryover, and byproduct impurities of febuxostat and its intermediates. © Patheon Inc. All rights reserved.

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