Pharmaceutical Ingredients Verification

USP is not currently accepting applications for pharmaceutical ingredient and excipient verification services. Learn more about our Good Manufacturing Practices Audit Program.

USP Verified Pharmaceutical Ingredients and Excipients undergo:

  • Good manufacturing practice (GMP) manufacturing and facilities audits
  • A review of drug substance or excipient chemistry, manufacturing, and controls (CMC) documentation
  • Drug substances or excipients laboratory testing for conformance to specifications
  • Ongoing change monitoring and surveillance
Name of Holder: Beijing Geyantianrun Bio-tech Co., Ltd.
Address: No. 3, Tianfu Road, Daxing Bio-Medicine Industry Park, Beijing, China 102609

Name of Pharmaceutical Ingredient: Trypsin
Pharmaceutical Ingredient Codes: Y-DT
Site(s) of Production:
No. 3, Tianfu Road, Daxing Bio-Medicine Industry Park, Beijing, China 102609
Certificate Number: VER-PI/DS-BGB-001
Awarded: September 16, 2013 — Expires: September 16, 2016

Name of Pharmaceutical Ingredient: Chymotrypsin
Pharmaceutical Ingredient Code: Y-DCT
Site of Production: No. 3, Tianfu Road, Daxing Bio-Medicine Industry Park, Beijing, China 102609
Certificate Number: VER-PI/DS-BGB-002
Awarded: January 23, 2015 – Expires: January 23, 2018

Name of Holder: Malladi Drugs and Pharmaceuticals Limited
Address:

9, GST Road, Saint Thomas Mount, Chennai, India 600016

Name of Pharmaceutical Ingredient: Pseudoephedrine Hydrochloride
Pharmaceutical Ingredient Specification Number: SPC/QC/FP/002/E
Site(s) of Production:
Unit-3, Plot 7B & 7C, State Industrial Promotion Corporation of Tamil Nadu (SIPCOT), Ranipet, Vellore District, Tamil Nadu, India 632403
Certificate Number: VER-PI/DS-MAL-010
Awarded: February 12, 2015 — Expires: February 12, 2018

Name of Pharmaceutical Ingredient: Phenylephrine Hydrochloride
Pharmaceutical Ingredient Specification Number: SPC/QC/FP/401/E
Site(s) of Production:
Unit-3, Plot 7B & 7C, State Industrial Promotion Corporation of Tamil Nadu (SIPCOT), Ranipet, Vellore District, Tamil Nadu, India 632403
Certificate Number: VER-PI/DS-MAL-011
Awarded: February 12, 2015 — Expires: February 12, 2018

Name of Pharmaceutical Ingredient: Phenylephrine Bitartrate
Pharmaceutical Ingredient Specification Number: SPC/QC/FP/405/E
Site(s) of Production:
Unit-3, Plot 7B & 7C, State Industrial Promotion Corporation of Tamil Nadu (SIPCOT), Ranipet, Vellore District, Tamil Nadu, India 632403
Certificate Number: VER-PI/DS-MAL-012
Awarded: February 12, 2015 — Expires: February 12, 2018

Name of Holder: Shenzhen Hepalink Pharmaceutical Group Co., Ltd.
Address: No. 21 Langshan Road, Songpingshan, Nanshan District,
Shenzhen, P.R. China 518057

Name of Pharmaceutical Ingredient: Heparin Sodium
Pharmaceutical Ingredient Product Codes: 302
Site(s) of Production:
No. 21 Langshan Road, Songpingshan, Nanshan District, Shenzhen, P.R. China 518057
Certificate Number: VER-PI/DS-HEP-002
Awarded: January 26, 2016 — Expires: May 05, 2018