Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
01 1Olpha
02 1Jai Radhe Sales
03 1Polydrug Laboratories Private Limited
04 1Siegfried AG
05 1Techno Drugs & Intermediates
06 1Unipex
01 1France
02 3India
03 1Latvia
04 1Switzerland
01 1Active
02 1Inactive
03 4Blank
01 1Valid
02 1Withdrawn by EDQM Failure to CEP procedure
03 4Blank
01 6Blank
01 1WC-0220
02 1WC-0333
03 4Blank
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
Certificate Number : CEP 2013-148 - Rev 01
Issue Date : 2024-10-28
Type : Chemical
Substance Number : 383
Status : Valid
NDC Package Code : 63818-0005
Start Marketing Date : 2021-06-07
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9006
Submission : 1991-02-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23069
Submission : 2009-08-19
Status : Inactive
Type : II
Certificate Number : R0-CEP 2009-112 - Rev 00
Issue Date : 2010-06-22
Type : Chemical
Substance Number : 383
Status : Withdrawn by EDQM F...
Date of Issue : 2017-11-30
Valid Till : 2020-11-29
Written Confirmation Number : WC-0220
Address of the Firm :
Date of Issue : 2015-06-15
Valid Till : 2018-06-15
Written Confirmation Number : WC-0333
Address of the Firm :
A Chlorobutanol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Chlorobutanol, including repackagers and relabelers. The FDA regulates Chlorobutanol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Chlorobutanol API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Chlorobutanol supplier is an individual or a company that provides Chlorobutanol active pharmaceutical ingredient (API) or Chlorobutanol finished formulations upon request. The Chlorobutanol suppliers may include Chlorobutanol API manufacturers, exporters, distributors and traders.
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