Sigmapharm initiates a Voluntary Recall at the Retail Level for its drug product, Sodium Phenylbutyrate Powder, 250 Grams. This recall has been initiated due to the out of-specification (OOS) impurity results obtained during routine quality testing of a stability sample for one lot of Sodium Phenylbutyrate Powder, 250 Grams. This recall is being extended to all other potentially impacted lots as mentioned in the attached Recall letters dated August 13, 2021 and September 21, 2021.
Sigmapharm relaunches its generic Ultramicrosize Griseofulvin Tablets, USP 125 mg and 250 mg, exclusively under its own label.
Sigmapharm relaunches its generic Amiloride Hydrochloride Tablets, USP 5 mg, exclusively under its own label.
Ms. Mary E. Kohart, Esq., who had joined the company in October 2020 as its Vice President of the Legal Affairs Department, has now also become the General Counsel of Sigmapharm Laboratories. Effective today, Mary will be in charge of all legal matters of the company, including but not limited to Paragraph-IV patent challenges and commercial litigation, contractual matters and strategic negotiations. A short biographical note of Mary’s has now been posted in the MANAGEMENT section of our website.
Please note that all outside legal counsel, law firms, vendors, customers and other companies wishing to communicate with Sigmapharm Laboratories for any legal, litigation or contractual matters are now directed to contact only Ms. Mary Kohart at:
Mary E. Kohart, Esq.
General Counsel and Vice President, Legal Affairs
Sigmapharm Laboratories, LLC
3375 Progress Drive
Bensalem, PA 19020
Tel.: (215) 352-6649
- Sigmapharm receives FDA approval for generic Asenapine Sublingual Tablets, 5 mg and 10 mg, based on its ANDA No. 206107 containing a Paragraph IV certification.
- Sigmapharm launches its generic Asenapine Sublingual Tablets, 5 mg and 10 mg.
Sigmapharm relaunches its generic Protriptyline Hydrochloride Tablets, USP 5 mg and 10 mg, exclusively under its own label.
Sigmapharm relaunches its generic Griseofulvin Tablets, USP (microsize) 500 mg, exclusively under its own label.
Sigmapharm files an Abbreviated New Drug Application (ANDA No. 213896) which is designated by the FDA as a Competitive Generics Therapy (CGT) product.
Sigmapharm launches its generic Ambrisentan Tablets, 5mg and 10mg.