Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1Neuland Laboratories
03 1Breathgreen Pharmaceuticals
04 1Melody Healthcare Pvt Ltd
01 1INDACATEROL MALEATE
02 1INDACATEROL MALEATE (MICRONIZED AND NON-MICRONIZED)
03 1INDACATEROL MALEATE IH
04 1INDACATEROL MALEATE(MICRONIZED AND NON-MICRONIZED)
01 2India
02 1Spain
03 1U.S.A
01 4Active
01 4Blank
Inke S.A: APIs manufacturing plant.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34411
Submission : 2024-06-25
Status : Active
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34294
Submission : 2019-12-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39765
Submission : 2024-03-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38000
Submission : 2023-02-02
Status : Active
Type : II
A Indacaterol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Indacaterol, including repackagers and relabelers. The FDA regulates Indacaterol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Indacaterol 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Indacaterol supplier is an individual or a company that provides Indacaterol active pharmaceutical ingredient (API) or Indacaterol finished formulations upon request. The Indacaterol suppliers may include Indacaterol API manufacturers, exporters, distributors and traders.
click here to find a list of Indacaterol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Indacaterol DMF (Drug Master File) is a document detailing the whole manufacturing process of Indacaterol active pharmaceutical ingredient (API) in detail. Different forms of Indacaterol DMFs exist exist since differing nations have different regulations, such as Indacaterol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Indacaterol DMF submitted to regulatory agencies in the US is known as a USDMF. Indacaterol USDMF includes data on Indacaterol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Indacaterol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Indacaterol suppliers with USDMF on PharmaCompass.
We have 4 companies offering Indacaterol
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