Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1Breathgreen Pharmaceuticals
01 2OLODATEROL HYDROCHLORIDE
01 1Spain
02 1U.S.A
01 2Active
01 1Complete
02 1Blank
Inke S.A: APIs manufacturing plant.
GDUFA
DMF Review : Complete
Rev. Date : 2023-08-23
Pay. Date : 2023-07-12
DMF Number : 38558
Submission : 2023-07-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38916
Submission : 2023-09-22
Status : Active
Type : II
A Olodaterol Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Olodaterol Hydrochloride, including repackagers and relabelers. The FDA regulates Olodaterol Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Olodaterol Hydrochloride 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 Olodaterol Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Olodaterol Hydrochloride supplier is an individual or a company that provides Olodaterol Hydrochloride active pharmaceutical ingredient (API) or Olodaterol Hydrochloride finished formulations upon request. The Olodaterol Hydrochloride suppliers may include Olodaterol Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Olodaterol Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Olodaterol Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Olodaterol Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Olodaterol Hydrochloride DMFs exist exist since differing nations have different regulations, such as Olodaterol Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Olodaterol Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Olodaterol Hydrochloride USDMF includes data on Olodaterol Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Olodaterol Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Olodaterol Hydrochloride suppliers with USDMF on PharmaCompass.
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