Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
01 1CORAL DRUGS PRIVATE LIMITED New Delhi IN
02 1FERMION OY Espoo FI
03 1AREVIPHARMA GMBH Radebeul DE
04 1CURIA ITALY S.R.L. Origgio IT
05 1DERIVADOS QUIMICOS S.A.U. Alcantarilla ES
06 1GEDEON RICHTER PLC Budapest HU
07 1Unichem Laboratories Limited Mumbai IN
01 5Flutamide
02 1Flutamide, Micronised
03 1Flutamide, Unmilled; milled
01 1Finland
02 1Germany
03 1Hungary
04 2India
05 1Spain
06 1U.S.A
01 4Valid
02 3Withdrawn by Holder
Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
Certificate Number : CEP 2001-416 - Rev 04
Status : Valid
Issue Date : 2024-10-23
Type : Chemical
Substance Number : 1423
With Fermion, start the journey of your innovative API.
With Fermion, start the journey of your innovative API.
Certificate Number : R1-CEP 2002-134 - Rev 03
Status : Valid
Issue Date : 2019-11-18
Type : Chemical
Substance Number : 1423
Certificate Number : R1-CEP 2006-297 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2014-02-06
Type : Chemical
Substance Number : 1423
Certificate Number : CEP 2000-049 - Rev 07
Status : Valid
Issue Date : 2024-09-10
Type : Chemical
Substance Number : 1423
Certificate Number : CEP 2002-159 - Rev 06
Status : Valid
Issue Date : 2024-04-05
Type : Chemical
Substance Number : 1423
Certificate Number : R1-CEP 2004-282 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2011-12-15
Type : Chemical
Substance Number : 1423
Certificate Number : R0-CEP 2002-225 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2004-12-10
Type : Chemical
Substance Number : 1423
A Odyne manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Odyne, including repackagers and relabelers. The FDA regulates Odyne manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Odyne 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 Odyne supplier is an individual or a company that provides Odyne active pharmaceutical ingredient (API) or Odyne finished formulations upon request. The Odyne suppliers may include Odyne API manufacturers, exporters, distributors and traders.
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A Odyne CEP of the European Pharmacopoeia monograph is often referred to as a Odyne Certificate of Suitability (COS). The purpose of a Odyne CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Odyne EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Odyne to their clients by showing that a Odyne CEP has been issued for it. The manufacturer submits a Odyne CEP (COS) as part of the market authorization procedure, and it takes on the role of a Odyne CEP holder for the record. Additionally, the data presented in the Odyne CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Odyne DMF.
A Odyne CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Odyne CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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