Neuland Laboratories- A dedicated 100% API provider.
01 1Neuland Laboratories
01 1ROPINIROLE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-12-05
Pay. Date : 2013-04-16
DMF Number : 26414
Submission : 2012-09-14
Status : Active
Type : II
A Adartrel manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Adartrel, including repackagers and relabelers. The FDA regulates Adartrel manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Adartrel 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 Adartrel manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Adartrel supplier is an individual or a company that provides Adartrel active pharmaceutical ingredient (API) or Adartrel finished formulations upon request. The Adartrel suppliers may include Adartrel API manufacturers, exporters, distributors and traders.
click here to find a list of Adartrel suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Adartrel DMF (Drug Master File) is a document detailing the whole manufacturing process of Adartrel active pharmaceutical ingredient (API) in detail. Different forms of Adartrel DMFs exist exist since differing nations have different regulations, such as Adartrel USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Adartrel DMF submitted to regulatory agencies in the US is known as a USDMF. Adartrel USDMF includes data on Adartrel's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Adartrel USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Adartrel suppliers with USDMF on PharmaCompass.
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