Apex Healthcare Limited: ISO 9001:2008, WHO-GMP, US FDA-audited manufacturer & exporter of APIs, bulk drugs, and formulations.
01 1M/s Apex Healthcare limited
02 1M/s Ipca Laboratories Ltd
03 1M/s Swati Spentose Private Limited
04 1M/s Unichem Laboratories Limited
05 1M/s. Arch Pharmalabs Limited
01 1Piroxicam BP/EP
02 2Piroxicam BP/EP/USP
03 1Piroxicam BP/Ph.Eur
04 1Piroxicam IP/USP/Ph.Eur
01 1WC-0063
02 1WC-0165
03 1WC-0254
04 1WC-0409
05 1WC-0453
01 5India
Apex Healthcare Limited: ISO 9001:2008, WHO-GMP, US FDA-audited manufacturer & exporter of APIs, bulk drugs, and formulations.
Date of Issue : 2024-03-01
Valid Till : 2026-12-31
Written Confirmation Number : WC-0409
Address of the Firm : 4710, 4711, 4707-A/8, 4707-A/9, GIDC, Industrial Estate, Ankleshwar, Dist.Bharuc...
Date of Issue : 2023-06-28
Valid Till : 2026-05-24
Written Confirmation Number : WC-0254
Address of the Firm : 78JUN13, C-21/22 &F-40, MIDC, Phase II, Sagaon, Dombivli (E), Thane-421204, Maha...
Date of Issue : 2023-09-25
Valid Till : 2026-03-20
Written Confirmation Number : WC-0453
Address of the Firm : Plot NO.E-41,129&128/2, MIDCInd.Area,Tarapur,Boisar-401 506, Maharashtra, India
Date of Issue : 2022-06-15
Valid Till : 2025-07-07
Written Confirmation Number : WC-0165
Address of the Firm : Plot No. A-1/2102 & 2103, Phase-III, G.I.D.C Vapi-396195, Valsad, Gujarat, India
Date of Issue : 2022-06-30
Valid Till : 2025-07-28
Written Confirmation Number : WC-0063
Address of the Firm : Plot No. 99, MIDC Area - Dhatav Roha, Dist. Raigad, Roha, Raigad-402116, Maharas...
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A Roxiden manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Roxiden, including repackagers and relabelers. The FDA regulates Roxiden manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Roxiden 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 Roxiden supplier is an individual or a company that provides Roxiden active pharmaceutical ingredient (API) or Roxiden finished formulations upon request. The Roxiden suppliers may include Roxiden API manufacturers, exporters, distributors and traders.
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A Roxiden written confirmation (Roxiden WC) is an official document issued by a regulatory agency to a Roxiden manufacturer, verifying that the manufacturing facility of a Roxiden active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Roxiden APIs or Roxiden finished pharmaceutical products to another nation, regulatory agencies frequently require a Roxiden WC (written confirmation) as part of the regulatory process.
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