01 1Bajaj Healthcare
01 1THEOBROMINE
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39064
Submission : 2024-04-03
Status : Active
Type : II
A Theobromine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Theobromine, including repackagers and relabelers. The FDA regulates Theobromine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Theobromine 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 Theobromine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Theobromine supplier is an individual or a company that provides Theobromine active pharmaceutical ingredient (API) or Theobromine finished formulations upon request. The Theobromine suppliers may include Theobromine API manufacturers, exporters, distributors and traders.
click here to find a list of Theobromine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Theobromine DMF (Drug Master File) is a document detailing the whole manufacturing process of Theobromine active pharmaceutical ingredient (API) in detail. Different forms of Theobromine DMFs exist exist since differing nations have different regulations, such as Theobromine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Theobromine DMF submitted to regulatory agencies in the US is known as a USDMF. Theobromine USDMF includes data on Theobromine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Theobromine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Theobromine suppliers with USDMF on PharmaCompass.
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