Century has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.
01 1Century Pharmaceuticals
01 1ROXITHROMYCIN BP
01 1India
01 1Active
01 1Blank
Century has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34799
Submission : 2020-07-23
Status : Active
Type : II
A Roxithromycin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Roxithromycin, including repackagers and relabelers. The FDA regulates Roxithromycin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Roxithromycin 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 Roxithromycin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Roxithromycin supplier is an individual or a company that provides Roxithromycin active pharmaceutical ingredient (API) or Roxithromycin finished formulations upon request. The Roxithromycin suppliers may include Roxithromycin API manufacturers, exporters, distributors and traders.
click here to find a list of Roxithromycin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Roxithromycin DMF (Drug Master File) is a document detailing the whole manufacturing process of Roxithromycin active pharmaceutical ingredient (API) in detail. Different forms of Roxithromycin DMFs exist exist since differing nations have different regulations, such as Roxithromycin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Roxithromycin DMF submitted to regulatory agencies in the US is known as a USDMF. Roxithromycin USDMF includes data on Roxithromycin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Roxithromycin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Roxithromycin suppliers with USDMF on PharmaCompass.
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