01 2AbbVie Inc
02 1Polfa Tarchomin
03 2ANGUS Chemical Company
04 5Abbott Laboratories
05 1Alembic Pharmaceuticals Limited
06 2Anuh Pharma LTD
07 1Calyx Chemicals & Pharmaceuticals Limited
08 3Eli Lilly
09 2Ercros
10 1Fermic
11 1Forest Laboratories
12 1HEC Pharm
13 1Kaneka Corporation
14 1Metabolic Solutions
15 3Ningxia Qiyuan Pharmaceutical
16 3Pfizer Inc
17 2SM BIOMED
18 2Sandoz B2B
19 1The Dow Chemical Company
20 1Unimax Group
21 2XIAN LIJUN PHARMACEUTICAL
22 1Zhejiang Guobang Pharmaceutical
23 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13197
Submission : 1998-04-30
Status :
Type : II
Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13409
Submission : 1998-09-01
Status :
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-05-09
Pay. Date : 2013-09-25
DMF Number : 27155
Submission : 2015-11-10
Status :
Type : II
A Erythromycin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Erythromycin, including repackagers and relabelers. The FDA regulates Erythromycin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Erythromycin 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 Erythromycin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Erythromycin supplier is an individual or a company that provides Erythromycin active pharmaceutical ingredient (API) or Erythromycin finished formulations upon request. The Erythromycin suppliers may include Erythromycin API manufacturers, exporters, distributors and traders.
click here to find a list of Erythromycin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Erythromycin DMF (Drug Master File) is a document detailing the whole manufacturing process of Erythromycin active pharmaceutical ingredient (API) in detail. Different forms of Erythromycin DMFs exist exist since differing nations have different regulations, such as Erythromycin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Erythromycin DMF submitted to regulatory agencies in the US is known as a USDMF. Erythromycin USDMF includes data on Erythromycin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Erythromycin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Erythromycin suppliers with USDMF on PharmaCompass.
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