Regulatory Affairs

Neuland is committed to manufacturing products in total compliance with regulatory requirements and customer expectations. All process and manufacturing operations are in accordance with cGMP requirements, US FDA and ICH guidelines and regulations.

Neuland’s manufacturing facilities at Bonthapalli and Pashamylaram have been inspected by the US FDA and also hold GMP approval from several regulatory authorities. Neuland’s Pashamylaram facility received GMP certificate from German Health authority in June 2007 and the Bonthapally facility has been successfully audited by PMDA (Japan) in October 2008.

Neuland with 33 USDMFs, 15 Canadian DMFs, 9 DMFs in Australia, 3 DMFs in Japan and 363 DMFs in various European and other regulatory markets has an unrelenting commitment and continues to be a preferred source worldwide. Neuland is accredited with CoS from EDQM for 13 of its APIs across five therapeutic categories.

The Company supports the customers with complete documentation including Drug Master Files for their dosage form applications/ANDA filings.

Sl. No. Product
Therapeutic category USDMF COS Canada TGA EUDMF
1 Albuterol/ Salbumatol Antiashmatic Yes
2 Albuterol Sulfate/Salbutamol Sulphate Antiashmatic Yes Yes Yes Yes
3 Aripiprazole (Anhydrous Form-B) CNS Yes
4 Bosentan Monohydrate Vasodilator Yes
5 Ciprofloxacin Fluoroquinolones Yes Yes
6 Ciprofloxacin Hydrochloride Fluoroquinolones Yes Yes Yes
7 Deferasirox Iron Chelator Yes
8 Donepezil Hydrochloride Form I CNS Yes Yes Yes Yes
9 Enalapril Maleate Cardiovascular Yes Yes Yes Yes
10 Entacapone Form A CNS Yes Yes Yes Yes Yes (Filed in 7 EU countries)
11 Escitalopram Oxalate CNS Yes Yes Yes Yes (Filed in 28 EU countries)
12 Ezetimibe Cardiovascular Yes Yes
13 Ipratropium Bromide Anti-Asthmatic Yes Approval awaited
14 Itraconazole Powder Anti-fungal Yes Yes
15 Levetiracetam CNS Yes Yes Yes Yes Yes (Filed in 23 EU countries)
16 Levofloxacin Hemihydrate Fluoroquinolones Yes Yes Yes (Filed in 27 EU countries)
17 Linezolid Form II Antibacterial Yes
18 Mirtazapine CNS Yes Yes Yes Yes
19 Montelukast Sodium Anti-Asthmatic Yes
20 Moxifloxacin Hydrochloride Fluoroquinolones Yes Yes Yes (Filed in 20 EU countries)
21 Ofloxacin Fluoroquinolones Yes Yes Yes (Filed in 17 EU countries)
22 Olanzapine Form I CNS Yes Approval awaited Yes Yes Yes (Filed in 32 EU countries)
23 Paliperidone Palmitate Anti Psychotic Agent Yes
24 Ramipril Cardiovascular Yes Yes Yes
25 Ranitidine Hydrochloride (Form – I) Anti-Ulcerant Yes Yes Yes Yes
26 Ranitidine Hydrochloride (Form – II) Anti-Ulcerant Yes Yes Yes
27 Ropinirole CNS Yes
28 Ropinirole Hydrochloride CNS Yes Yes Yes (Filed in 26 EU countries)
29 Salmeterol Xinafoate Anti Asthmatic Yes Yes Yes (Filed in 3 EU countries)
30 Sotalol Hydrochloride Cardiovascular Yes Yes Yes
31 Voriconazole Anti Fungal Yes