ImmuCell Required to Prepare Second Submission of Final Major Technical Section for Re-Tain®
ImmuCell Corporation (ICCC)
US:NASDAQ Investor Relations:
immucell.com/investors
Company Research
Source: GlobeNewswire
PORTLAND, Maine, Aug. 24, 2021 (GLOBE NEWSWIRE) -- ImmuCell Corporation (Nasdaq: ICCC) (“ImmuCell” or the “Company”), a growing animal health company that develops, manufactures and markets scientifically-proven and practical products that improve the health and productivity of dairy and beef cattle, today announced that the FDA has issued a Technical Section Incomplete Letter covering the Chemistry, Manufacturing and Controls (CMC) Technical Section for Re-Tain® (Nisin A intramammary solution). The CMC Technical Section covers the commercial manufacturing requirements for the Drug Substance and resulting Drug Product. The Company previously received Technical Section Complete Letters from the FDA covering the other four major Technical Sections required for product approval. Re-Tain® is the Company’s new subclinical mastitis treatment for lactating dairy cows without a milk discard or meat withhold requirement. The Company’s objective is to demonstrate that its bacteriocin, N
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ICCC
Sec Filings
- 4/26/24 - Form DEF
- 4/10/24 - Form EFFECT
- 4/10/24 - Form 424B2
- ICCC's page on the SEC website