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TOPIC: Pan Drugs Indian generics banned from US??

Pan Drugs Indian generics banned from US?? 6 years 7 months ago #1161

  • SShady43
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Hello from the US..
I just read an article in Fierce Pharma about the FDA issuing a warning letter to Unimark, an API manufacturer in India for unsafe and unsanitary manufacturing practices and lack of testing and records/traceability of testing in their Mumbai facility. The article went on to say that several other manufacturing facilities in India have also been warned. It said that last month, Pan Drugs was also issued a warning letter for the same violations, also saying an "import alert banning any further products from being allowed into the US until the problems were resolved". Just a heads up...haven't heard these companies mentioned from any one who is buying their meds from India., but perhaps good to know...
2A/F2. 12 weeks Sof & Riba in 2015. Undetected at 4 wks. Relapsed. Treated w/24 weeks Sof/Riba/Dac 2016.
June 2017/ 24 weeks UND.
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Pan Drugs Indian generics banned from US?? 6 years 7 months ago #1181

  • emilio
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Welcome Shady

Well that's certainly one way for the Gilead back FDA to protect the market. I wonder what this little initiative has cost Gilead. We are all waiting to see how Gilead will back flip to protect their market. Too late to a degree but they will want to wring it for all this is worth. Em
Geno 1b F2/3 snce early 80s. Treated in 2008_9 for 63 weeks on INF/Riba. Commence Sof/Dac on 6 October 2015 and completed 18 weeks of tx. UND at 4-6 weeks, UND at EOT, SVR 2, SVR 6 and SVR 12 on 6 May 2016.
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Pan Drugs Indian generics banned from US?? 6 years 7 months ago #1189

  • Alsdad
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Creating fear about the quality of meds made by foreign pharma co's is standard practice by Big Pharma and their allies and shills, in order to discourage people from trying to obtain generics. When they're doing this, they don't mention that a large proportion of their own meds are made by these same foreign companies.
:lol:
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Pan Drugs Indian generics banned from US?? 6 years 7 months ago #1191

  • Jolie
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Hi,
I agree, this is all dirty warfare tactics to scare people from buying generic medicines.
They also forgot to mention that Gilead gets "royalties" paid from the sales of every generic drug, as per their licensing agreement with Indian companies. I read somewhere that in the case of generic Sovaldi this is 7% ??
Geno 3, Fibro 8.7 pKA, tx experinced in 2005 - Peg/Riba, relapsed.
Started tx 1/12/2015 with Indian Sofo & Chinese Dac.
5 weeks result all normal, ALT 18 - down from ALT 73 at the start of tx.
5 weeks HCV PCR RNA - UND. - down from 2 ML
9 weeks HCV PCR RNA - UND.
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Pan Drugs Indian generics banned from US?? 6 years 7 months ago #1193

  • LondonGirl
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They should hurry up and release HepcinatLP and other generics then - If they don't provide access to affordable medicines, concerned patients will go elsewhere, our health is at risk!
GT1a Dec14 F2/8.7 VL 900000-2.5M
Jan16 Hepcivir-L MonkMed/Redemption
Baseline: VL 913575 Alt 76 Platelets low
Wk2 VL1157 Alt 23
DET Wk 8 VL 32 Alt19 'In the slow lane'
June16 Fibro 5.7 F0/1 LIF 1.5
Wk 11 VL<12 Alt 13 Det/Unq
Extending tx 12 wks Mylan Sofo/Dac MonkMed
Wk 14 VL <12 Det/Unq
Wk 16 VL UNDETECTED
Wk 22 + 4 Wks Sunprevir FixHepC
Wk 24 UNDETECTED Alt 13
Wk 12 post tx SVR12 Wk 26 SVR24
Thank-you Tim, Dr Debasis @ MonkMed & Dr Freeman @ Fix HepC
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Pan Drugs Indian generics banned from US?? 6 years 7 months ago #1201

  • Sirchinenge
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I think Al's hit the nail on the head they have their own product made in the same factories.
Sob/Dac from Oct 29 2015
Geno 1b
Fiberscan 9.9 Pre treatment
Fiberscan 7.4 week 10
VL 1.3 million pre treatment
Week 2.5 VL 96
Week 5.5 VL 17
Week 10 VL UD
SVR 3 UD
SVR 16 UD
Cured:
All liver functions in normal ranges.
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Pan Drugs Indian generics banned from US?? 6 years 7 months ago #1207

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pphheww, that was easy enough. sorry bout that. em
Geno 1b F2/3 snce early 80s. Treated in 2008_9 for 63 weeks on INF/Riba. Commence Sof/Dac on 6 October 2015 and completed 18 weeks of tx. UND at 4-6 weeks, UND at EOT, SVR 2, SVR 6 and SVR 12 on 6 May 2016.
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Pan Drugs Indian generics banned from US?? 6 years 7 months ago #1208

  • Sirchinenge
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Ah, you found it. Well done!
Sob/Dac from Oct 29 2015
Geno 1b
Fiberscan 9.9 Pre treatment
Fiberscan 7.4 week 10
VL 1.3 million pre treatment
Week 2.5 VL 96
Week 5.5 VL 17
Week 10 VL UD
SVR 3 UD
SVR 16 UD
Cured:
All liver functions in normal ranges.
Last Edit: 6 years 7 months ago by Sirchinenge.
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