Inke S.A: APIs manufacturing plant.
01 1Inke S.A.
02 1CADILA PHARMACEUTICALS LIMITED.
03 1Daito Co., Ltd.
04 1Morepen Laboratories Limited
05 1Rolabo Outsourcing,S. L.
06 1Tianish Laboratories Private Limited
07 1Vasudha Pharma Chem Limited
01 6Loratadine
02 1Loratadine (production only)
01 3India
02 1Japan
03 2Spain
04 1U.S.A
Registration Number : 222MF10170
Registrant's Address : Area Industrial del Llobregat, C/Argent 1,08755 Castellbisbal Barcelona SPAIN
Initial Date of Registration : 2010-06-08
Latest Date of Registration : 2010-06-08
Loratadine (for manufacturing purposes only)
Registration Number : 222MF10187
Registrant's Address : Sarkhej-Dholka Road, Bhat, Ahmedabad-382 210, Gujarat, INDIA
Initial Date of Registration : 2010-07-02
Latest Date of Registration : 2017-06-21
Registration Number : 222MF10175
Registrant's Address : 326 Yokamachi, Toyama City, Toyama Prefecture
Initial Date of Registration : 2010-06-18
Latest Date of Registration : 2021-08-16
Registration Number : 227MF10263
Registrant's Address : 2nd Floor, Tower C, DLF Cyber Park, Udyog Vihar, Sector-20, Gurugram-Haryana, 1...
Initial Date of Registration : 2015-11-11
Latest Date of Registration : 2021-10-13
Registration Number : 304MF10093
Registrant's Address : Poligono Industrial Malpica C/J, No. :3-4 50016 Zaragoza, Spain
Initial Date of Registration : 2022-06-28
Latest Date of Registration : 2022-06-28
Registration Number : 306MF10126
Registrant's Address : 78/A, Bengalrao Nagar, Hyderabad 500 038, Telangana State, India.
Initial Date of Registration : 2024-09-18
Latest Date of Registration : 2024-09-18
Registration Number : 220MF10191
Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India
Initial Date of Registration : 2008-08-18
Latest Date of Registration : 2018-06-14
A Loratadine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Loratadine, including repackagers and relabelers. The FDA regulates Loratadine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Loratadine 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 Loratadine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Loratadine supplier is an individual or a company that provides Loratadine active pharmaceutical ingredient (API) or Loratadine finished formulations upon request. The Loratadine suppliers may include Loratadine API manufacturers, exporters, distributors and traders.
click here to find a list of Loratadine 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 Loratadine Drug Master File in Japan (Loratadine JDMF) empowers Loratadine 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 Loratadine JDMF during the approval evaluation for pharmaceutical products. At the time of Loratadine 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 Loratadine suppliers with JDMF on PharmaCompass.
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