Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1Pharmaceutical Works POLPHARMA S. A.
02 1Ipca Laboratories Limited
03 1Minsheng Group Shaoxing Pharmaceutical Co. , Ltd.
04 1Ryoto Fine Co., Ltd.
05 1Shaanxi Hanjiang Pharmaceutical Group Co. , Ltd.
06 1Tianish Laboratories Private Limited
01 5Alendronate sodium hydrate
02 1Japanese Pharmacopoeia alendronate sodium hydrate (production only)
01 2China
02 1India
03 1Japan
04 1Poland
05 1U.S.A
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Registration Number : 220MF10241
Registrant's Address : 19 Pellinska Str. 83-200 Starogard Gdanski POLAND
Initial Date of Registration : 2008-12-04
Latest Date of Registration : 2018-01-15
Registration Number : 219MF10310
Registrant's Address : 48, Kandivli Industrial Estate, Kandivli (West), Mumbai 400 067, India
Initial Date of Registration : 2007-10-05
Latest Date of Registration : 2022-07-27
Japanese Pharmacopoeia Alendronate Sodium Hydrate (For manufacturing only)
Registration Number : 229MF10112
Registrant's Address : 315, Tanggong Road, Paojiang Industrial Zone, Shaoxing, P. R. China
Initial Date of Registration : 2017-06-29
Latest Date of Registration : 2017-06-29
Registration Number : 228MF10049
Registrant's Address : 1410 Takada, Kashiwa City, Chiba Prefecture
Initial Date of Registration : 2016-02-08
Latest Date of Registration : 2022-06-28
Registration Number : 227MF10301
Registrant's Address : No. 3, Lianhua Road, Hanzhong Hi-tech Industries Development Zone Hanzhong City, Shaa...
Initial Date of Registration : 2015-12-28
Latest Date of Registration : 2023-12-19
Registration Number : 220MF10178
Registrant's Address : Plot No. 564/A/22, Road No. 92, Jubilee Hills, Hyderabad-500096, Telangana, India
Initial Date of Registration : 2008-07-31
Latest Date of Registration : 2008-07-31
A Fosamax manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fosamax, including repackagers and relabelers. The FDA regulates Fosamax manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fosamax 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 Fosamax manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fosamax supplier is an individual or a company that provides Fosamax active pharmaceutical ingredient (API) or Fosamax finished formulations upon request. The Fosamax suppliers may include Fosamax API manufacturers, exporters, distributors and traders.
click here to find a list of Fosamax 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 Fosamax Drug Master File in Japan (Fosamax JDMF) empowers Fosamax 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 Fosamax JDMF during the approval evaluation for pharmaceutical products. At the time of Fosamax 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 Fosamax suppliers with JDMF on PharmaCompass.
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