DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories Ltd.
02 1Ohara Pharmaceutical Co., Ltd.
03 1Solara Active Pharma Sciences Limited
01 1Japanese Pharmacopoeia nizatidine (production only)
02 1NIZATIDINE
03 1Nizatidine
01 2India
02 1Japan
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Registration Number : 218MF10215
Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA
Initial Date of Registration : 2006-02-16
Latest Date of Registration : 2022-01-11
Japanese Pharmacopoeia Nizatidine (for manufacturing only)
Registration Number : 220MF10171
Registrant's Address : 121-15 Toriiino, Koka-cho, Koka City, Shiga Prefecture
Initial Date of Registration : 2008-07-24
Latest Date of Registration : 2008-07-24
Registration Number : 223MF10080
Registrant's Address : The Batra Center, No. 28, Sardar Patel Road, Guindy, Chennai 600 032. India
Initial Date of Registration : 2011-06-15
Latest Date of Registration : 2011-06-15
A Nizatidine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nizatidine, including repackagers and relabelers. The FDA regulates Nizatidine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nizatidine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Nizatidine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nizatidine supplier is an individual or a company that provides Nizatidine active pharmaceutical ingredient (API) or Nizatidine finished formulations upon request. The Nizatidine suppliers may include Nizatidine API manufacturers, exporters, distributors and traders.
click here to find a list of Nizatidine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Nizatidine Drug Master File in Japan (Nizatidine JDMF) empowers Nizatidine API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Nizatidine JDMF during the approval evaluation for pharmaceutical products. At the time of Nizatidine JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Nizatidine suppliers with JDMF on PharmaCompass.
We have 3 companies offering Nizatidine
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