Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
01 1Nuray Chemicals Private Limited
02 1FARMAK, a.s
03 1Biophore India Pharmaceuticals Pvt Ltd
04 1Dr. Reddy's Laboratories
05 1Neuland Laboratories
06 1Alivus Life Sciences
07 1Aurobindo Pharma Limited
08 1Aurore Life Sciences
09 1Honour Lab
10 1MSN Laboratories
11 1Navinta
12 1Optimus Pharma
13 1Saptagir Laboratories
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Complete
Rev. Date : 2020-09-15
Pay. Date : 2020-08-03
DMF Number : 35066
Submission : 2020-08-05
Status :
Type : II
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38912
Submission : 2023-09-26
Status :
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37205
Submission : 2022-06-24
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37979
Submission : 2023-02-21
Status :
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36341
Submission : 2021-11-03
Status :
Type : II
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A Vyndaqel manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vyndaqel, including repackagers and relabelers. The FDA regulates Vyndaqel manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vyndaqel API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Vyndaqel supplier is an individual or a company that provides Vyndaqel active pharmaceutical ingredient (API) or Vyndaqel finished formulations upon request. The Vyndaqel suppliers may include Vyndaqel API manufacturers, exporters, distributors and traders.
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A Vyndaqel DMF (Drug Master File) is a document detailing the whole manufacturing process of Vyndaqel active pharmaceutical ingredient (API) in detail. Different forms of Vyndaqel DMFs exist exist since differing nations have different regulations, such as Vyndaqel USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Vyndaqel DMF submitted to regulatory agencies in the US is known as a USDMF. Vyndaqel USDMF includes data on Vyndaqel's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vyndaqel USDMF is kept confidential to protect the manufacturer’s intellectual property.
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