01 1Saneca Pharmaceuticals a. s.
02 1SpecGx LLC
01 2Pethidine hydrochloride
01 1Ireland
02 1Slovakia
Registration Number : 218MF10904
Registrant's Address : 385 Marshall Ave, Webster Groves, Missouri 63119, United States
Initial Date of Registration : 2006-11-10
Latest Date of Registration : 2007-09-18
Registration Number : 223MF10069
Registrant's Address : Nitrianska 100,920 27 Hlohovec, Slovak Republic
Initial Date of Registration : 2011-05-25
Latest Date of Registration : 2024-02-29
A Pethidine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pethidine Hydrochloride, including repackagers and relabelers. The FDA regulates Pethidine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pethidine Hydrochloride 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 Pethidine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pethidine Hydrochloride supplier is an individual or a company that provides Pethidine Hydrochloride active pharmaceutical ingredient (API) or Pethidine Hydrochloride finished formulations upon request. The Pethidine Hydrochloride suppliers may include Pethidine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Pethidine Hydrochloride 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 Pethidine Hydrochloride Drug Master File in Japan (Pethidine Hydrochloride JDMF) empowers Pethidine Hydrochloride 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 Pethidine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Pethidine Hydrochloride 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 Pethidine Hydrochloride suppliers with JDMF on PharmaCompass.
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