world class pharma ingredients - neuland labs · 2020-07-03 · escitalopram oxalate antidepressant...
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For further details visit: www.neulandlabs.com October 2017
World ClassPharma Ingredients
APIProduct List
For further details visit: www.neulandlabs.comDisclaimer: The above product list includes some products which are still under protection in India and other countries. Products covered under valid patents in India and other countries will be available for supply only after expiry of the respective patents in india and the respective country.
Product Therapeutic Segment USDMF CEP/E-DMF
Albuterol Sulfate/Salbutamol Sulphate Bronchodilator ✔ CEP
Alcaftadine Allergic Conjunctivitis ✔ N/A
Bosentan Monohydrate Pulmonary Artery Hypertension ✔ E-DMF
Cipro�oxacin Base Antibacterial ✔ CEP
Cipro�oxacin Hydrochloride Antibacterial ✔ CEP
Dabigatran Etexilate Mesylate‡ Anticoagulant ✔ E-DMF
Deferasirox Iron Chelator ✔ E-DMF
Donepezil Base Alzheimer's Disease N/A E-DMF
Donepezil Hydrochloride Alzheimer's Disease ✔ E-DMF
Dorzolamide Hydrochloride Anti-Glaucoma N/A CEP
Enalapril Maleate Antihypertensive ✔ CEP
Entacapone Antiparkinson Agent ✔ CEP
Escitalopram Oxalate Antidepressant ✔ CEP*
Ezetimibe Antihyperlipidemic ✔ E-DMF
Ipratropium Bromide Anticholinergic ✔ CEP
Itraconazole Antifungal ✔ CEP
Labetalol Hydrochloride Antihypertensive ✔ CEP*
Levetiracetam Anticonvulsant ✔ CEP
Levo�oxacin Hemihydrate Antibacterial ✔ E-DMF
Linezolid Antibacterial ✔ E-DMF
Lurasidone Hydrochloride Antipsychotic ✔ E-DMF
Mirtazapine Antidepressant ✔ CEP
Moxi�oxacin Hydrochloride Antibacterial ✔ CEP*
Moxonidine Antihypertensive N/A CEP
O�oxacin Antibacterial ✔ E-DMF
Olanzapine Antipsychotic ✔ CEP
Propofol Anesthetic ✔ CEP
Ramipril Antihypertensive ✔ CEP
Rivaroxaban Anticoagulant ✔ E-DMF
Ropinirole Base Antiparkinson Agent ✔ E-DMF
Ropinirole Hydrochloride Antiparkinson Agent ✔ CEP*
Salmeterol Xinafoate Bronchodilator ✔ CEP
Sotalol Hydrochloride Antiarrhythmic ✔ CEP
Voriconazole Antifungal ✔ CEP
Commercial & Commercial-Scale Products
E-DMF Filed/Ready for Filing N/A Not Applicable ‡ Patents granted in US/Europe * Application Filed and Under ReviewⓅ Product Validation in Plant Over, DMF Under Preparation Ⓥ Product Validation in Progress
Product Therapeutic Segment USDMF CEP/E-DMFAllopurinol Antigout Ⓥ ⓋApixaban Anticoagulant Ⓟ ⓅApremilast Psoriatic Arthritis Ⓥ ⓋAripiprazole Anhydrous Antipsychotic Ⓟ ⓅAripiprazole Monohydrate (Sterile) Antipsychotic Ⓥ ⓋAripiprazole Lauroxil Antipsychotic Ⓥ ⓋFebuxostat Antigout Ⓥ ⓋHydralazine (For Oral) Antihypertensive Ⓥ ⓋIndacaterol Maleate Bronchodilator Ⓥ ⓋOlanzapine Form-II Antipsychotic Ⓥ ⓋOlanzapine Pamoate Antipsychotic Ⓥ ⓋPaliperidone Antipsychotic Ⓥ ⓋPaliperidone Palmitate (Sterile)‡ Antipsychotic Ⓟ ⓅPirfenidone Idiopathic Pulmonary Fibrosis Ⓥ ⓋPosaconazole Antifungal Ⓟ ⓅRotigotine‡ Antiparkinson Agent Ⓟ ⓅRu�namide‡ Anticonvulsant Ⓥ ⓋSaxagliptin‡ Antidiabetic Ⓥ ⓋSugammadex‡ Selective Relaxant Binding Agent (SRBA) Ⓥ ⓋTicagrelor Platelet Aggregation Inhibitors Ⓟ Ⓟ
Development Products
Product Therapeutic Segment
Small MoleculeBrexpiprazole Antipsychotic
Brivaracetam Anticonvulsant
Canagli�ozin Antidiabetic
Cariprazine Antipsychotic
Crisaborole Dermatology
Eluxadoline Irritable Bowel Syndrome
Empagli�ozin Antidiabetic
Ivabradine Hydrochloride Antianginal
Li�tegrast Ophthalmological
Sacubitril-Valsartan Cardiovascular
Sitagliptin Antidiabetic
Vilanterol Bronchodilator
Peptide
Liraglutide Antidiabetic
Octreotide Growth-Hormone Antagonist
R&D Pipeline Products
India Corporate O�ce | Tel: +91 40 3021 1600India Mumbai O�ce | Tel: +91 22 4004 6035Japan O�ce | Tel: +81 3 3526 5171USA O�ce | Tel: +1 888 617 9587
www.neulandlabs.com
Facilities Certi�cation
World Class Pharma IngredientsOur core business and operational expertise has, for over 33 years, been the manufacturing and marketing of active pharmaceutical ingredients (APIs). During this time Neuland has become a preferred and reliable source for leading pharmaceutical companies worldwide. This is primarily due to: consistency in product quality; knowledge and ability to deal with niche chemistry; and on-time delivery performance.
The Company’s strength in process development, regulatory knowledge, controlled supply chain and online project management makes Neuland an ideal API partner. Additionally, with proven experience of API manufacturing at varied scales, Neuland also o�ers custom manufacturing solutions (CMS) as well as custom synthesis services for small molecules and peptides.
Our FacilitiesWith two world-class manufacturing facilities (both USFDA and EU GMP compliant) and a state-of-art R&D centre, Neuland currently produces more than 75 APIs in diverse therapeutic areas with over 650 DMFs worldwide.Key features include:● Two world-class manufacturing plants with 7 production
blocks in Unit 1 and 6 production blocks in Unit 2, covering 2,800 to 4,500m2 of production area, and a mini-plant for scaling up of new products
● Total reactor volume of around 523 KL and capable of handling a broad range of reactions and wide choice of process parameters
● Quality, EHS and compliance is at the heart of Neuland and across our facilities, with a track record of regulatory approvals (12 successful US FDA inspections)
For Business Development Enquiries please contact:India: [email protected] | Japan: [email protected] | North America: [email protected] America: [email protected] | Europe: [email protected] | Rest of the World: [email protected]
Our R&D centre was USFDA inspected in 2016
Authority Unit 1
USFDA (USA)
EDQM (Europe)
EMA (Europe)
PMDA (Japan)
TGA (Australia)
BfArM (Germany)
AFSSAPS (France)
ANVISA (Brazil)
COFEPRIS (Mexico)
KFDA (South Korea)
WHO GMP
ISO 14001:2004
OHSAS 18001:2007
ISO 9001:2008
ISO 27001:2013
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Unit 2