01 1Breathgreen Pharmaceuticals
02 1Cipla
01 1INDACATEROL ACETATE
02 1INDACATEROL ACETATE(MICRONIZED AND NON-MICRONIZED)
01 1India
02 1U.S.A
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39764
Submission : 2024-03-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37098
Submission : 2022-05-13
Status : Active
Type : II
A Indacaterol Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Indacaterol Acetate, including repackagers and relabelers. The FDA regulates Indacaterol Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Indacaterol Acetate 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 Indacaterol Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Indacaterol Acetate supplier is an individual or a company that provides Indacaterol Acetate active pharmaceutical ingredient (API) or Indacaterol Acetate finished formulations upon request. The Indacaterol Acetate suppliers may include Indacaterol Acetate API manufacturers, exporters, distributors and traders.
click here to find a list of Indacaterol Acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Indacaterol Acetate DMF (Drug Master File) is a document detailing the whole manufacturing process of Indacaterol Acetate active pharmaceutical ingredient (API) in detail. Different forms of Indacaterol Acetate DMFs exist exist since differing nations have different regulations, such as Indacaterol Acetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Indacaterol Acetate DMF submitted to regulatory agencies in the US is known as a USDMF. Indacaterol Acetate USDMF includes data on Indacaterol Acetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Indacaterol Acetate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Indacaterol Acetate suppliers with USDMF on PharmaCompass.
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