DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories
02 1TAPI Technology & API Services
03 1AmbioPharm
04 1Auro Peptides Limited
05 1CordenPharma
06 1GLAND PHARMA LIMITED
07 1Hybio Pharmaceutical
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-05
Pay. Date : 2013-12-31
DMF Number : 25855
Submission : 2012-03-24
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7609
Submission : 1988-08-02
Status :
Type : II
A Glatiramer Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glatiramer Acetate, including repackagers and relabelers. The FDA regulates Glatiramer Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glatiramer 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 Glatiramer Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Glatiramer Acetate supplier is an individual or a company that provides Glatiramer Acetate active pharmaceutical ingredient (API) or Glatiramer Acetate finished formulations upon request. The Glatiramer Acetate suppliers may include Glatiramer Acetate API manufacturers, exporters, distributors and traders.
click here to find a list of Glatiramer Acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Glatiramer Acetate DMF (Drug Master File) is a document detailing the whole manufacturing process of Glatiramer Acetate active pharmaceutical ingredient (API) in detail. Different forms of Glatiramer Acetate DMFs exist exist since differing nations have different regulations, such as Glatiramer Acetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Glatiramer Acetate DMF submitted to regulatory agencies in the US is known as a USDMF. Glatiramer Acetate USDMF includes data on Glatiramer Acetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Glatiramer Acetate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Glatiramer Acetate suppliers with USDMF on PharmaCompass.
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