Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
01 2GRANULES INDIA LIMITED Hyderabad IN
02 2SYNTHOKEM LABS PRIVATE LIMITED Hyderabad IN
03 1BIESTERFELD SPEZIALCHEMIE GMBH Hamburg DE
04 1DELTA SYNTHETIC CO., LTD. New Taipei City TW
05 1M/s Stellar Chemical Laboratories PVT Limited Mumbai IN
06 1RHODIA OPERATIONS SAS Aubervilliers FR
07 1SEVEN STAR PHARMACEUTICAL COMPANY, LTD. New Taipei City TW
08 1SMILAX LABORATORIES LIMITED Hyderabad IN
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Certificate Number : R0-CEP 2021-332 - Rev 00
Status : Valid
Issue Date : 2021-12-10
Type : Chemical
Substance Number : 615
Synthokem Labs specializes in producing APIs and intermediates for the global pharma industry.
Certificate Number : R1-CEP 1999-088 - Rev 05
Status : Valid
Issue Date : 2018-06-26
Type : Chemical
Substance Number : 615
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Certificate Number : R1-CEP 2009-201 - Rev 03
Status : Valid
Issue Date : 2018-11-27
Type : Chemical
Substance Number : 615
Synthokem Labs specializes in producing APIs and intermediates for the global pharma industry.
Certificate Number : CEP 2019-065 - Rev 01
Status : Valid
Issue Date : 2025-01-15
Type : Chemical
Substance Number : 615
A Oresol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oresol, including repackagers and relabelers. The FDA regulates Oresol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oresol 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 Oresol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Oresol supplier is an individual or a company that provides Oresol active pharmaceutical ingredient (API) or Oresol finished formulations upon request. The Oresol suppliers may include Oresol API manufacturers, exporters, distributors and traders.
click here to find a list of Oresol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Oresol CEP of the European Pharmacopoeia monograph is often referred to as a Oresol Certificate of Suitability (COS). The purpose of a Oresol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Oresol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Oresol to their clients by showing that a Oresol CEP has been issued for it. The manufacturer submits a Oresol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Oresol CEP holder for the record. Additionally, the data presented in the Oresol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Oresol DMF.
A Oresol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Oresol CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Oresol suppliers with CEP (COS) on PharmaCompass.
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