USP Verified Pharmaceutical Ingredients—Drug Substances & Excipients

Name of Holder:Arch Pharmalabs Limited
Address:
'H' Wing, 4th Floor, Tex Centre, Off Saki Vihar Road, Chandivali, Andheri (East), Mumbai – 400072 India

Name of Pharmaceutical Ingredient: Clopidogrel Bisulfate (Form 1)
Pharmaceutical Ingredient Product Codes: 04-02-CLPBF1
Site(s) of Production:
Address: Village Pathreri, Bilaspur Tauru Road, District Gurgaon, Haryanan 122 001 India
Certificate Number: VER-PI/DS-ARCH-001
Awarded: April 17, 2009 — Expires: April 17, 2012

Name of Holder:Deepak Fertilisers and Petrochemicals Corporation Limited
Address:Plot K-1, MIDC Industrial Area, Taloja, A.V., District Raigad, Maharashtra, India 410208

Name of Pharmaceutical Ingredient: Isopropyl Alcohol
Pharmaceutical Ingredient Product Codes: 32500
Site(s) of Production:
Address: Plot K-1, MIDC Industrial Area, Taloja, A.V., District Raigad, Maharashtra, India 410208
Certificate Number: VER-PI/EX-DFPC-001
Awarded: April 03, 2009 — Expires: April 03, 2012

Name of Holder:Dr. Reddy's Laboratories Limited
Address:7-1-27, Ameerpet, Hyderabad, Andhra Pradesh, India 500016

Name of Pharmaceutical Ingredient: Clopidogrel Bisulfate (Form I)
Pharmaceutical Ingredient SAP Code: 350000091 & 350000374
Site(s) of Production:
Address: Unit I, Plot No. 137 & 138, S. V. Co-Op. Industrial Estate, Bollaram, Jinnaram Mandal, Medak District, Andhra Pradesh, India 502325
Certificate Number: VER-PI/DS-DRL-003
Awarded: October 4, 2007 — Expires: October 4, 2010

Name of Pharmaceutical Ingredient: Finasteride (Form III)
Pharmaceutical Ingredient Specification Code; SAP Code: S-08-FS3-USP/03; 200000544
Site(s) of Production:
Address: Unit II, Plot No. 110 & 111, S. V. Co-Op Industrial Estate, Bollaram, Jinnaram, Medak District, Andhra Pradesh, India 502325
Certificate Number: VER-PI/DS-DRL-002
Awarded: September 21, 2007 — Expires: September 21, 2010

Name of Pharmaceutical Ingredient: Naproxen
Pharmaceutical Ingredient Specification Code; SAP Code: 200001350
Site(s) of Production:
Address: Unit V, Pyddadevulapally, Tripuraram Mandal, Nalgonda District, Andhra Pradesh, India 508207
Certificate Number: VER-PI/DS-DRL-006
Awarded: March 03, 2009 — Expires: March 03, 2012

Name of Pharmaceutical Ingredient: Naproxen Sodium
Pharmaceutical Ingredient Specification Code; SAP Code: 200001351
Site(s) of Production:
Address: Unit V, Pyddadevulapally, Tripuraram Mandal, Nalgonda District, Andhra Pradesh, India 508207
Certificate Number: VER-PI/DS-DRL-007
Awarded: March 03, 2009 — Expires: March 03, 2012

Name of Pharmaceutical Ingredient: Nizatidine
Pharmaceutical Ingredient SAP Code: 350000547
Site(s) of Production:
Address: Unit VI, APIIC Industrial Estate, Pydibhimavaram, Ranasthalam Mandal, Srikakulam District, Andhra Pradesh, India 532409
Certificate Number: VER-PI/DS-DRL-005
Awarded: January 07, 2009 — Expires: January 07, 2012

Name of Pharmaceutical Ingredient: Olanzapine (Form I)
Pharmaceutical Ingredient SAP Code: 200005047
Site(s) of Production:
Address: Unit IV, Plot 9/A, Phase -3, IDA Jeedimetla, Hyderabad, Andhra Pradesh, India 500055
Certificate Number: VER-PI/DS-DRL-004
Awarded: October 4, 2007 — Expires: October 4, 2010

Name of Pharmaceutical Ingredient: Ramipril
Pharmaceutical Ingredient Specification Code; SAP Code: S-08-TR-USP/03; 200000323
Site(s) of Production:
Address: Unit III, Plot No. 116, S.V. Co-Op. Industrial Estate, Bollaram, Jinnaram Mandal, Medak District, Andhra Pradesh, India, 502325
Certificate Number: VER-PI/DS-DRL-001
Awarded: September 21, 2007 — Expires: September 21, 2010

Name of Holder:Jubilant Life Sciences Ltd.
Address:
No.56, KIADB Industrial Area, Nanjanagud 571 302, Mysore, Karnataka, India

Name of Pharmaceutical Ingredient: Losartan Potassium
Pharmaceutical Ingredient Product Codes: LST
Site(s) of Production:
Plot# 18, 56, 57 & 58 KIADB Industrial Area, Nanjanagud 571 302, Mysore, Karnataka, India
Certificate Number: VER-PI/DS-JUB-001
Awarded: January 6, 2012 — Expires: 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 04, 2011— Expires: April 04, 2014

Name of Pharmaceutical Ingredient: Crospovidone (Polyplasdone XL and Polyplasdone XL-10)
Pharmaceutical Ingredient Product Codes: Polyplasdone XL: 1172104###3, 1372104###3, 1472104###3, 1572104###3, 1672104###3, 1772104###3; Polyplasdone 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-008
Awarded: June 11, 2008 — Expires: June 11, 2011

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: 1372473###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 03, 2011— Expires: September 03, 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 03, 2011— Expires: September 03, 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: 1472030###5); Plasdone K-29/32 (Base Code: 72030; Specification Code: 1872030###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: 1172015###5); Plasdone C-15 (Base Code: 72200; Specification Code 1272200###5); Plasdone C-15 (Base Code: 72211; Specification Code 1572211###5); Plasdone C-17 (Base Code: 72623; Specification Code: 1172623###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:1172086###5); Plasdone K-17 (Base Code: 72489; Specification Code: 1172489###5); Plasdone K-17 (Base Code: 72625; Specification Code: 1172625###5); Plasdone K-25 (Base Code: 72026; Specification Code: 1172026###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 03, 2011— Expires: September 03, 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 09, 2009 — Expires: December 09, 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 09, 2009 — Expires: December 09, 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 09, 2009 — Expires: December 09, 2012

Name of Holder:Rexim S.A.S.
Address:33, Rue de Verdun, HAM, France 80400

Name of Pharmaceutical Ingredient: P-HIG L-Methionine
Pharmaceutical Ingredient Product Codes: 95811601A2; NDC Number: 16947-8201-1
Site(s) of Production:
Address: No. 10 Wenjing Road, Wuming County, Nanning, 530100, Guangxi, P.R. China
Certificate Number: VER-PI/DS-ERNP-001
Awarded: March 06, 2009 — Expires: March 06, 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, 2011

Name of Pharmaceutical Ingredient: Lansoprazole
Pharmaceutical Ingredient Item 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