USP Verified Pharmaceutical Ingredients—Drug Substances & Excipients

Name of Holder:Jubilant Life Sciences Ltd.
Address:No.56, KIADB Industrial Area, Nanjanagud, Mysore, Karnataka, India 571302

Name of Pharmaceutical Ingredient: Losartan Potassium
Pharmaceutical Ingredient Product Codes: LST
Site(s) of Production:
Plot#18, 56, 57 & 58 KIADB Industrial Area, Nanjangud 571 302, Mysore, Karnataka, India
Certificate Number: VER-PI/DS-JUB-001
Awarded: January 6, 2012 — Expired: January 6, 2015

Name of Holder:International Specialty Products (ISP)
Address:455 North Main Street, Calvert City, KY 42029

Name of Pharmaceutical Ingredient: Povidone (Plasdone K-90)
Pharmaceutical Ingredient Product Codes: 1172045###3, 1272045###3, 1572045###3, 1872045###3, 1972045###3
Site(s) of Production:
Address: 455 North Main Street, Calvert City, KY 42029
Certificate Number: VER-PI/DS-ISP-007
Awarded: May 12, 2011 — Expires: May 12, 2014

Name of Pharmaceutical Ingredient: Povidone-Iodine (PVP Iodine)
Pharmaceutical Ingredient Product Codes: 117A338###3, 1172338###3, 1272338###3, 1272501###3, 1572501###3, 1672501###3

Site(s) of Production:
Address: 455 North Main Street, Calvert City, KY 42029
Certificate Number: VER-PI/DS-ISP-012
Awarded: April 4, 2011 — Expires: April 4, 2014

Name of Pharmaceutical Ingredient: Crospovidone (Polyplasdone XL and Polyplasdone XL-10)
Pharmaceutical Ingredient Product Codes: Poliplasdona XL: 1172104###3, 1372104###3, 1472104###3, 1572104###3, 1672104###3, 1772104###3; Poliplasdona XL-10: 1172118###3, 1272118###3, 1372118###3, 1472118###3.
Site(s) of Production:
Address: 455 North Main Street, Calvert City, KY 42029
Certificate Number: VER-PI/EX-ISP-009
Awarded: June 11, 2011 — Expires: June 11, 2014

Name of Pharmaceutical Ingredient: Copovidone: Plasdone S-630
Pharmaceutical Ingredient Product Codes: Plasdone S-630 (Base Code:: 72473; Specification Code: 1272473###5); Plasdone S-630 (Base Code: 72473; Specification Code: 622.543,21kg##5); Plasdone S-630 (Base Code: 72473; Specification Code: 1472473###5)
Site(s) of Production:
Address: 4501 Attwater Ave. Texas City, TX 77592
Certificate Number: VER-PI/EX-ISP-010
Awarded: September 3, 2011 — Expires: September 3, 2014

Name of Pharmaceutical Ingredient: Crospovidone: Polyplasdone XL, Polyplasdone XL 10, Polyplasdone ULTRA, Polyplasdone ULTRA 10
Pharmaceutical Ingredient Product Codes: Polyplasdone XL (Base Code: 72104; Specification Code: 1172104###5); Polyplasdone XL 10 (Base Code: 72118; Specification Code: 1172118###5); Polyplasdone ULTRA (Base Code: 72789; Specification Code: 1172789###5) Polyplasdone ULTRA 10 (Base Code: 72791; Specification Code: 1172791###5)
Site(s) of Production:
Address: 4501 Attwater Ave. Texas City, TX 77592
Certificate Number: VER-PI/EX-ISP-011
Awarded: September 3, 2011 — Expires: September 3, 2014

Name of Pharmaceutical Ingredient: Povidone: Plasdone K-29/32, Plasdone C-12, Plasdone C-15, Plasdone C-17, Plasdone C-30, Plasdone K-12, Plasdone K-15; Plasdone K-17, and Plasdone K-25
Pharmaceutical Ingredient Product Codes: Plasdone K-29/32 (Base Code: 72030; Specification Code: 1272030###5); Plasdone K-29/32 (Base Code: 72030; Specification Code: 667.701,50kg##5); Plasdone K-29/32 (Base Code: 72030; Specification Code: 849.138,43kg##5); Plasdone K-29/32 (Base Code: 72030; Specification Code: 1C72030###5); Plasdone K-29/32 (Base Code: 72089; Specification Code: 1172089###5); Plasdone C-12 (Base Code: 72015; Specification Code: 531.617,00kg##5); Plasdone C-15 (Base Code: 72200; Specification Code: 1272200###5); Plasdone C-15 (Base Code: 72211; Specification Code: 713.142,84kg##5); Plasdone C-17 (Base Code: 72623; Specification Code: 531.892,79kg##5); Plasdone C-30 (Base Code: 72020; Specification Code: 1272020###5); Plasdone K-12 (Base Code: 72380; Specification Code:1172380###5); Plasdone K-15 (Base Code: 72086; Specification Code:531.649,21kg##5); Plasdone K-17 (Base Code: 72489; Specification Code: 531.832,01kg##5); Plasdone K-17 (Base Code: 72625; Specification Code: 531.893,69kg##5); Plasdone K-25 (Base Code: 72026; Specification Code: 531.621,99kg##5); Plasdone K-25 (Base Code: 72026; Specification Code: 1272026###5)
Site(s) of Production:
Address: 4501 Attwater Ave. Texas City, TX 77592
Certificate Number: VER-PI/EX-ISP-009
Awarded: September 3, 2011 — Expires: September 3, 2014

Name of Holder:Malladi Drugs and Pharmaceuticals Limited
Address:No. 52, Jawaharlal Nehru Road, Ekkattuthangal, Guindy, Chennai, India 600 097

Name of Pharmaceutical Ingredient: Phenylephrine Bitartrate
Pharmaceutical Ingredient Specification Number: SPC/QC/FP/405/A
Site(s) of Production:
Address: Plot 7B & 7C, SIPCOT Industrial Complex, Ranipet-632 403 Vellore District, Tamil Nadu, India
Certificate Number: VER-PI/DS-MAL-001
Awarded: December 9, 2009 — Expires: December 9, 2012

Name of Pharmaceutical Ingredient: Phenylephrine Hydrochloride
Pharmaceutical Ingredient Specification Number: SPC/QC/FP/401/D
Site(s) of Production:
Address: Plot 7B & 7C, SIPCOT Industrial Complex, Ranipet-632 403 Vellore District, Tamil Nadu, India
Certificate Number: VER-PI/DS-MAL-002
Awarded: December 9, 2009 — Expires: December 9, 2012

Name of Pharmaceutical Ingredient: Pseudoephedrine Hydrochloride
Pharmaceutical Ingredient Specification Number: SPC/QC/FP/002/C
Site(s) of Production:
Address: Plot 7B & 7C, SIPCOT Industrial Complex, Ranipet-632 403 Vellore District, Tamil Nadu, India
Certificate Number: VER-PI/DS-MAL-003
Awarded: December 9, 2009 — Expires: December 9, 2012

Name of Holder:Ulkar Kimya San. ve Tic. A.S.
Address:Inklap Mah., Akcakoca Sk, No: 10 Umraniye, Istanbul, Turkey 34768

Name of Pharmaceutical Ingredient: Pantoprazole Sodium Sesquihydrate
Pharmaceutical Ingredient Item Code: 11000066
Site(s) of Production:
Address: Organize Sanayi Bolgesi, Fatih Blvd. No. 9, Cerkezkoy, Tekirdag, Turkey 59500
Certificate Number: VER-PI/DS-ULK-001
Awarded: September 30, 2010 — Expires: September 30, 2013

Name of Pharmaceutical Ingredient: Lansoprazole
Pharmaceutical Ingredient Code: 11000067
Site(s) of Production:
Address: Organize Sanayi Bolgesi, Fatih Blvd. No. 9, Cerkezkoy, Tekirdag, Turkey 59500
Certificate Number: VER-PI/DS-ULK-002
Awarded: May 6, 2011 — Expires: May 6, 2014

Name of Pharmaceutical Ingredient: Aripiprazole
Pharmaceutical Ingredient Item Code: 11000078
Site(s) of Production:
Address: Organize Sanayi Bolgesi, Fatih Blvd. No. 9, Cerkezkoy, Tekirdag, Turkey 59500
Certificate Number: VER-PI/DS-ULK-003
Awarded: February 14, 2012 — Expires: February 14, 2015

Name of Pharmaceutical Ingredient: Etodolac
Pharmaceutical Ingredient Item Code: 11000079
Site(s) of Production:
Address: Organize Sanayi Bolgesi, Fatih Blvd. No. 9, Cerkezkoy, Tekirdag, Turkey 59500
Certificate Number: VER-PI/DS-ULK-004
Awarded: April 27, 2012 — Expires: April 27, 2015