News

USFDA has allowed drug manufacturers additional time for submission of mitigation actions and required changes for nitrosamine impurities as recommended under RAIL guidance. In August 2023, FDA issued the RAIL guidance (Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities...

Indian drug regulator CDSCO has published the Not of Standard Quality (NSQ) alert lists for May 2025. A total of 58 drugs were declared NSQ by CDSCO’s Central Laboratories, while State Laboratories reported an additional 128 NSQ cases during the...

USFDA has issued the final guidance for Pre-Submission Facility Correspondence (PFC) for prioritised generic drug submissions. This guidance describes the facility information to be submitted in a pre-submission facility correspondence (PFC). Under section 505(j)(11) of the FD&C Act, an 8-month...

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter in June 2025 to Chinese drug manufacturer Yiling Pharmaceutical Ltd., (FEI 3011640199) citing serious deficiencies in equipment cleaning and inadequate cross-contamination prevention measures. The facility underwent inspection in...

The USFDA issued a notification on 22 May, 2025 on Data Integrity concerns on reliability and validity of biocompatibility testing and animal safety and performance testing studies conducted for Medical devices by third Party testing facilities. As per the notification...

Indian regulatory agency, CDSCO has updated the requirements for application and issuance of Export NOC for Unapproved Drugs / Unapproved New Drugs. As per the new procedure published by CDSCO on 7 May 2025, if the drug is approved by...

The Drugs Technical Advisory Board (DTAB) in India has recommended for amendment of Drug Rules for suspension of Product License of drugs declared Not of Standard Quality (NSQ) by a Government Testing Laboratory.  In its 92nd meeting held on 24...

Indian drug regulator CDSCO (Central Drugs Standards Control Organisation) has published the Not of Standard Quality (NSQ) drugs list for March 2025. CDSCO has published two lists  - one for the NSQ Alerts reported by the Central / CDSCO laboratories...

Cronus Pharma LLC on behalf of Cronus Pharma Specialties, Hyderabad, India initiated a recall of Dexmedetomidine Hydrochloride Injection 0.5 mg/mL due to particulates matter in the product. Two lots of the product, Dexased (Aspen Veterinary Resources, LTD) & DexmedVet (Cronus...

USFDA 483 issued to Glenmark Pharma’s Pithampur facility (FEI: 3008565058) in India flagged critical deviations in cleaning and beta-lactam contamination control issues. Other deviations cited include lapses in handling Out-of-Specification (OOS) and Out-of-Trend (OOT) results, analytical method validations and delays...

Breckenridge Pharmaceutical Inc. has announced the recall of over 360,000 bottles of Duloxetine Delayed-Release Capsules across various strengths in the U.S., citing the detection of Nitrosamine Drug Substance-Related Impurity (NDSRI) above FDA acceptable limits. The drug product is manufactured by...

USFDA has announced the Quality Management Maturity (QMM) Prototype Assessment Protocol Evaluation Program for the second year. It provides opportunity for a limited number of drug manufacturers to participate in the programme to evaluate Quality Management Maturity. CDER will accept...

WHO has published a comprehensive and easy to understand guideline for control of nitrosamines in pharmaceutical products. The TRS 1060 - Annex 2: WHO good practice considerations for the prevention and control of nitrosamines in pharmaceutical products is applicable for...

The Central Drugs Standard Control Organisation (CDSCO) has published the NSQ (Not of Standard Quality) list of drugs for February 2025. The list comprises two parts—one detailing drugs identified as NSQ by Central Laboratories and the other by State Laboratories....

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Aspen Biopharma Labs Private Limited, citing serious cGMP violations at its API manufacturing facility in Sangareddy, Hyderabad. The site (FEI 3012796281) was audited in September 2024 by FDA...

Indian drug regulatory, CDSCO has notified the new online Export NOC system for Unapproved Drugs / Unapproved New Drugs. As per the new system application for Export NOC shall be submitted online through CDSCOs Sugam portal @ https://cdscoonline.gov.in/. CDSCO has...

The U.S. Food and Drug Administration (FDA) has approved Sanofi’s Qfitlia (fitusiran) for the treatment of Hemophilia. Hemophilia is a genetic bleeding disorder caused by a dysfunction or deficiency of coagulation factor VIII or IX. Patients with this condition are...

The U.S. FDA issued a warning letter to International Laboratories Corp. (FEI 3006403166) following CGMP violations observed during an inspection at the firm's Bang Phli District facility in September 2024. International Laboratories Corp (ILC) is a Thailand based manufacturer and...

Strides Pharma Inc is recalling over 38 lots of Testosterone Gel 1% in the US due to presence of benzene contaminant as per California State Board of Pharmacy Recall Alert. The benzene contaminant is resulting from one of the excipients...

Glenmark Pharmaceuticals has initiated a recall of over 1.5 million bottles of their ADHD medication, Atomoxetine, across the US and Europe due to the presence of the nitrosamine impurity N-Nitroso atomoxetine. This marks the first recall of Atomoxetine for the...

Indian API manufacturer Global Calcium Pvt Ltd was issued a Warning letter by USFDA in January 2025. This was along expected lines, after serious data integrity issues and CGMP violations observed by FDA investigators Justin A. Boyd and Teresa I....

FDA issued Warning letter to two Chinese API manufacturers following for cGMP violations including failing to meet USP specifications, inadequate stability data, deficient cleaning validation and inappropriate controls over incoming material testing. The FDA inspected Wuhu Nuowei Chemistry Co., Ltd...

Health Ministry in India has extended the timeline for implementation of the revised Schedule M by one year for MSMEs. The new timeline for implementation of the revised Schedule M by MSMEs (Micro Small and Medium Enterprises) with a turnover...

In December 2024, the Indian drug regulator, CDSCO, flagged 51 drugs as Not of Standard Quality (NSQ). As part of continuous regulatory surveillance, Central and State Drug authorities routinely collect samples of drug products from points of sale and distribution...

The USFDA issued a warning letter in January 2025 to Sanofi's API facility in Framingham, Massachusetts. This followed critical deviations observed during an FDA inspection of the facility in July 2024. The cGMP lapses include: failures to investigate deviations comprehensively...

The FDA has issued new guidance on "Considerations for Complying With 21 CFR 211.110." According to 21 CFR 211.110, manufacturers are required to establish and follow written procedures that describe the in-process controls, tests, or examinations to be conducted on...

Indoco Remedies' Goa Plant (FEI 3005124189) received a warning letter from the FDA following critical observations during an audit in July 2024. The violations of Current Good Manufacturing Practice (CGMP) observed include lapses in microbiology laboratory control, sterile area validation,...

The USFDA has issued a Warning Letter to Hyderabad-based OTC manufacturer Akron Formulations for critical deviations in the manufacture of drug products. The Warning Letter, issued in December 2024 following a review of records submitted by Akron to FDA in...

The Indian drug regulator, CDSCO, has published a list of spurious drugs detected in November 2024. During regulatory surveillance, drug inspectors in Bihar identified spurious samples of the popular acidity medicine Pan 40 (Pantoprazole by Alkem). Similarly, drug inspectors in...

Adding to the growing number of drug recalls due to NDSRIs in 2024, Glenmark is recalling three lots of the antipsychotic drug Chlorpromazine. This is the first recall of Chlorpromazine for the nitrosamine drug substance-related impurity (NDSRI) N-nitroso-desmethyl-chlorpromazine. NDSRIs are...

The USPTO is withdrawing the proposed new rule which was published in the Federal Register in May 2024. The new rule effectively proposed patent applicants for terminal disclaimers to agree that invalidating the parent patent claim would render related terminal...

USFDA has approved Checkpoint Therapeutics Cosibelimab-ipdl (Unloxcyt) for treatment of skin cancer CSCC (metastatic cutaneous squamous cell carcinoma). Cosibelimab-ipdl is a programmed death ligand-1 (PD-L1) blocking antibody. Unloxcyt dosage is 1200mg administered as an intravenous infusion every three weeks. As per a...

The USFDA has approved Neurocrine Biosciences' new drug, Crenessity (Crinecerfont), for the treatment of classic congenital adrenal hyperplasia (CAH). Crinecerfont is an adjunctive treatment to glucocorticoid replacement to control androgens in adult and pediatric patients. CAH is a rare genetic...

Several lots of the antidepressant drug Duloxetine, manufactured by Aurobindo, India, have been recalled in the US due to the nitrosamine impurity NDSRI, N-Nitroso-duloxetine. More than 600K bottles of Duloxetine Capsules across strengths of 20mg, 30mg, and 60mg were recalled...

The Central Drugs Standard Control Organization (CDSCO) has issued a spurious drug alert for popular medications  - Alkem’s Taxim-O (Antibiotic Cefixime), Pan D (Pantoprazole + Domperidone for acidity and indigestion), and Sun Pharma’s Rosuvas 10 (Rosuvastatin for lowering cholesterol). Samples...

In September 2024, the European Commission (EC) revoked the Conditional Marketing Authorisation (CMA) for Advanz Pharma’s Ocaliva (obeticholic acid), a second-line treatment for patients with primary biliary cholangitis (PBC). But the General Court of the European Union temporarily suspended the...

New Delhi based Unexo Life Sciences has initiated a major recall of several medicated patch drug products in US following critical deviations flagged by USFDA in the manufacture of drug products. The recall include more than 12 Million patches of...

Aurobindo is recalling Cinacalcet tablets in US due to nitrosamine NDSRI impurity N-Nitroso-cinacalcet. Aurobindo has initiated recall of 17 batches of the drug product across different strengths 30 mg, 60 mg and 90 mg Cinacalcet tablets Earlier in October 2024,...

Chinese OTC Manufacturer Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd was inspected by USFDA in March 2024. During the inspection FDA observed significant GMP violations at the facility (FEI 3006283468). Manufacturing – Filling equipment were observed to be dirty and, in...

USFDA is proposing to remove oral phenylephrine as an active ingredient in over-the-counter (OTC) drug products for nasal congestion. An review determined that oral phenylephrine is not effective for relief of nasal congestion. As this is a proposed order, companies may...

FDA has published the USFDA Form 483 issued to Novo Nordisk API manufacturing facility at Kalundborg, Denmark. The site (FEI 3002807751) which manufacture the block buster Semaglutide was inspected by USFDA investigators Lindsey Brown, Ralph M. Bernstein, Maxwell Korang-Yeboah, and...

The USFDA has published a new guidance titled "Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA," intended for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs). DMF holders can request an...

CDSCO has published list of sixtyseven Drugs & Medicinal products as Not of Standard Quality (NSQ) in September 2024. Central and State Drug authorities routinely pick samples of drug products from point of sale and distribution points and get the...

CDSCO has published list of drugs declared as spurious in the month of September 2024. The list includes popular medicines Deca-Durabolin 25 Injection (Zydus), Shelcal 500 (Torrent), Urimax D (Cipla), Pan D (Alkem). CDSCO routinely samples drugs and medicines from sales...

Accord Healthcare Inc, US is recalling one lot of Cisplatin injection due to failed impurities. The drug product is manufactured by Intas Pharmaceuticals at their Pharmez facility in Ahmedabad, India. The recall was initiated after batch P2202009 failed for unspecified...

USFDA has approved Inavolisib ((Itovebi) of Genentech in combination with palbociclib and fulvestrant, for the treatment of PIK3CA-mutated HR-positive HER2-negative breast cancer. As per Roche press release HR-positive breast cancer is the most prevalent type of all breast cancers, accounting...

The European Medicines Agency (EMA) has initiated a review of finasteride and dutasteride due to concerns about suicidal ideation (suicidal thoughts) and behaviors. In Europe, medicines containing finasteride and dutasteride are marketed under various trade names such as Propecia (Organon),...

CDSCO has published an update on the Spurious and Misbranded drugs in September 2024. Medicinal Products of Pharma Majors Sun Pharma (Pulmosil, Pantocid, Ursocol 300), Glenmark (Telma H) and Macleods (Defcort 6) which were found to be failing for different...

CDSCO has published alert of list of drugs Not of Standard Quality (NSQ) identified during Aug 2024. Fortyeight incidents of Not of Standard Quality drugs are reported by the Central Laboratories (Chandigarh, Kolkata and Guwahati) in August 2024. The list...

FDA has issued an Updated Guidance for Control of Nitrosamines in Human Drugs in September 2024. This guidance revises the final guidance of the same title issued on February 24, 2021. Qvents presents in this post the salient changes and...

Following the USFDA 483 issued in April 2024 and the OAI classification in July 2024, Zydus' Jarod facility (FEI 3013712903) was issued a Warning Letter by the USFDA in August 2024. The facility was inspected in April 2024 by FDA...

The European Commission (EC) revoked the conditional marketing authorization (CMA) of Advanz Pharma’s Ocaliva (obeticholic acid) in Europe for the second-line treatment of patients with primary biliary cholangitis (PBC) in September 2024. However, Advanz Pharma has secured a temporary suspension...

CDSCO has published a drug alert regarding voluntary recall of Tisseel Lyo Fibrin Sealant VHS/D Powder and solvent for sealant by Baxter. The imported product is manufactured by Takeda in Vienna, Austria. The recall is is due to extended dissolution...

CDSCO has published the NSQ (Not of Standard Quality) alert for July 2024. The list published by CDSCO on 22 Aug 2024, lists fifty seven drug products and include common drugs like Paracetamol, Ofloxacin, Azithromycin, Aspirin, Pantoprazole, Diclofenac. More than...

Dr.Reddy’s laboratories Inc (DRL) has initiated recall of 50 batches of Ibuprofen tablets in US market. DRL is recalling Ibuprofen tablets of three different strengths – 800mg, 600mg and 400mg. The recall is initiated based on the results observed in...

FDA has given approval for Janssen’s New Molecular Entity Lazertinib (Lazcluze). Approval is accorded for Lazertinib in combination with amivantamab-vmjw (Rybrevant) for treatment of non-small cell lung cancer (NSCLC). Lazertinib is a kinase inhibitor of epidermal growth factor receptor. Rybrevant plus...

Latest circular issued by CDSCO on Good Distribution Practices (GDP) indicate that the guidance on GDP could be incorporated as a schedule in Drugs and Cosmetics Act, 1945. CDSCOs Drug Consultative Committee (DCC) apprehend that due to non-mandatory nature of...

Gilead announced FDAs approval of Livdelzi (Seladelpar) for treatment of PBC, a rare, chronic, autoimmune disease of the bile ducts. PBC can cause liver damage and possible liver failure if untreated. The disease currently has no cure. (FDA) granted accelerated...

The USFDA has announced the fiscal year (FY) 2025 rates for GDUFA III fees. The FY 25 fee show a steep hike of ANDA fee to ₹ 3,21,920 from $ 252,453 for FY 24, an increase of 27.5%. The new...

South Korean Drug Regulator MFDS imposed administrative penalties on GlaxoSmithKline (GSK), reports Korea Bio Medical Review. The penalties are for violation of regulations Pharmaceutical Affairs Act and Rules on the Safety of Pharmaceuticals and Other Drugs. According to the MFDS...

Zydus Pharmaceuticals (USA) Inc initiated recall of multiple lots of Verapamil Hydrochloride injection due to potential cross contamination with other products. Verapamil Hydrochloride is a calcium channel blocker medication used for the treatment of high blood pressure, angina. The drug...

CDSCO has published list of drugs which were found to be not of standard quality for the month of May 2024, during tests at CDSCO (Central) laboratories and State laboratories of the Drug Control Authority. The medicines which were found...

Cipla facility at Verna, Goa was audited by USFDA during June 2024 ending with issuance of USFDA form 483 with six observations. The site was inspected from 10 June to 21 June 2024 by three investigators Tamil Arasu, Eileen A.Liu...

Glenmark Pharmaceuticals is recalling 114 batches of Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K due to failed dissolution. Following this, there was one more recall  of 21 batches of Potassium Chloride Capsules by American Health Packaging on...

FDA has issued final guidance on Circumstances that constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection in June 2024. This is the final version of the draft guidance that was issued in December 2022 on same title....

USFDA 483 issued to Dr.Reddys (DRL) API unit in Pydibhimavaram, India cites failure to validate all analytical methods, failure to maintain manufacturing processes in validated state, Investigations and root cause into OOS and failures were not scientifically sound. The 483...

EDQM has published the draft guideline on Content of the dossier for sterile substances for public consultation. For a sterile drug substance (API), sterilisation process should be described in CEP application along with data for validation of sterilisation method in...

The guidance provides information on how FDA decides goal dates for a drug application (ANDA, BLA, NDA) based on information provided in the Form 356h regarding Facility readiness. This is a program enhancement as described in the GDUFA Reauthorization Performance...

Eugia US LLC is recalling two more injectable products in US for failed impurities, degradation specifications. Four lots of Dexamethasone Sodium Phosphate injection is being recalled for out of specification (OOS) results of sulfonic acid adduct of dexamethasone phosphate impurity...

The scientific community mourns the loss of Dr.Akiro Endo, whose death was announced by the Tokyo University of Agriculture and Technology where Dr.Endo was a professor emeritus. Dr.Endo’s groundbreaking research has been compared to the discovery of penicillin and led...

USFDA had inspected the Jiangsu Hengrui Pharma’s Huanghe road site in January 2024. The site was inspected by investigators Arsen Karapetyan and Qiao Y Bobo and the Firm was issued USFDA 483 with 8 observations. Following the inspection, the site...

Glenmark recalled several lots of Rizatriptan Benzoate Tablets and Rizatriptan Benzoate Orally Disintegrating Tablets in US due presence of Nitrosamine impurities. The recall is triggered due to the Nitrosamine Drug Substance Related Impurity (NDSRI) N-Nitroso Desmethyl Rizatriptan results that are...

Elanco Animal Health announced that the USFDA has completed its comprehensive, multi-year review of Bovaer (3-NOP), a methane-reducing feed ingredient, and determined the product meets safety and efficacy requirements for use in lactating dairy cattle. Bovaer with active ingredient 3-Nitroxy...

Dr.Reddy’s (DRL) is recalling 1176 bottles of Sirolimus 1mg tablets (NDC 55111-653-01) in US for failed impurities in degradation specification. The recall was initiated on 1 May 2024. Sirolimus (also known as Rapamycin) is an immunosuppressant indicated for the prophylaxis...

Everest Organics Ltd (Telangana, India) was issued a GMP Non-Compliance Report with recommendation to suspend the CEP certificate for Omeprazole, by Norwegian Authority. The NCA report followed an inspection in February 2024 at its Sangareddy, Telengana site in which major...

CDSCO has issued spurious drug alert for five medicinal products. The spurious drug alert includes popular brands like Emcure’s Instgra (Dolutegravir tablets), Glenmark’s Telma -AM (Telmisartan & Amlodipine tablets) and Sun Pharma’s Rifagut 400 (Rifaximin tablets). Other drugs in the...

Aurobindo arm, Eugia Pharma Specialities facility at Bhiwadi, Rajasthan was issued USFDA 483 with seven observations following inspection in April -May 2024. The facility (FEI 3009883410) was inspected by USFDA investigators Justin A Boyd, Anastasia M Shields and Vaishali J...

USFDA inspection of Zydus Life sciences, Vadodara facility resulted in USFDA 483 with 10 observations. The facility (FEI 3013712903) was inspected by USFDA investigators Justin A Boyd and Anastasia M Shields in April 2024. Major deficiencies observed were pertaining to...

The Drug Controller General of India (DCGI) has notified that effective from May 15, 2024, the issuance of Export No Objection Certificates (NOCs) for new, unapproved, and banned drugs will transition from State Licensing Authorities (SLAs) to Central Drugs Standard Control Organization (CDSCO)...

WHO has issued an alert on falsified Propylene glycol bearing name of Dow detected in Pakistan. Authentic Dow USP/EP propylene glycol is a Pharmaceutical raw material (excipient) adhering to the standards of the United States and European Pharmacopoeias (USP/EP) for...

The USFDA 483 issued to Sun Pharma, Dadra unit in India (FEI 3004561553) published by USFDA demonstrates the depths audits go to identify non compliances and highlights the evolving expectations of auditors. The site was inspected by USFDA investigator Pratik...

J&Js paediatric cough syrup Benylin is being recalled in several African countries following detection of high level of diethylene glycol contamination. The recall was triggered in Nigeria (April 10, 2024) after laboratory tests on a batch of  Benylin Paediatric showed...

The revised EDQM guideline “Content of the dossier for chemical purity and microbiological quality of substances for pharmaceutical use” will be effective from 1st May 2024. The  key updates are with regards to   information to be included in the Module...

As expected FDA has taken regulatory action and issued a Warning letter to Natco, following critical observations during inspection at Natco’s Kothur facility in India. The site was inspected in October 2023, by investigators Pratik S. Upadhyay and Saleem A....

USFDA Warning letter to Australian API manufacturer cites basic laboratory compliance issues - Inadequate OOS investigations, failure to follow USP monograph methods, laboratory records do not capture all relevant test details to establish traceability and validity of data and failure...

USFDA inspected Jubilant Generics Limited facility in Roorkee, India, from January 25th to February 2nd, 2024. The USFDA 483 issued at the close of inspection by investigators Jaffrey P. Raimondi and Tamil Arasu cites deficiencies on cleaning validations, inadequate investigations,...

Natco Pharma is recalling one more lot of Lanzoprazole 15 mg delayed release capsules for cGMP deviations in March 2024. The drug is distributed by Rising Pharma Holdings. Lanzoprazole is indicated for treatment of frequent heartburn. The Lanzoprazole capsules are...

The USFDA released draft guidance on New Dietary Ingredient Notification (NDIN) Master Files for dietary supplements in April 2024. Let's break down what this means for the industry. What are NDIs and NDINs? A New Dietary Ingredient (NDI) is any...

Glenmark has initiated a recall of one lot of Diltiazem Hydrochloride 120mg, Extended Release(ER) Capsules in US in Mar 2024. The class II recall is due to Failed Dissolution Specifications during long term stability studies at the at the 12th...

FDA has announced the over-the-counter (OTC) monograph drug facility (MDF) fee rates under the OTC monograph drug user fee program (OMUFA) for fiscal year (FY) 2024. These facility fees are effective on October 1, 2023, and will remain in effect...

FDA approved Akebia’s Vafseo (Vadadustat) for treatment of anaemia due to Chronic Kidney Disease (CKD) in patients receiving dialysis for at least three months. Vafseo is a once daily oral tablet and recommended starting dose 300 mg. Vafseo is available...

FDA has approved Merck’s Biologic drug Winrevair (Sotatercept-CSRK) for Pulmonary Arterial Hypertension (PAH). The product is available in 45mg and 60mg lyophilized cake or powder single dose vials for subcutaneous injection. The recommended starting dose is 0.3mg/kg and target dose...

Eugia US LLC is recalling one lot of Methocarbamol Injection in US for white particles observed to be floating in the vial. The recall follows a customer complaint. Particulates in injection has potential to cause stroke and even death if...

FDA has issued a new guidance for handling reserve samples from bioavailability (BA) and bioequivalence (BE) studies for study sponsors and/or drug manufacturers, contract research organizations (CROs), site management organizations (SMOs), and investigators. The guidance is for immediate implementation. The...

USFDA has approved Italfarmaco’s Duvyzat (givinostat) oral medication for treatment of Duchenne Muscular Dystrophy (DMD). Duvyzat is a non steroidal drug for treatment of DMD, a rare neurological disorder, characterised by progressive muscle weakness due to lack of muscle protein,...

USFDA has approved Idorsia's new drug Tryvio, a New Molecular Entity (NME) drug Aprocitentan for treatment of high blood pressure in patients who are not responding well to other medications. However, the approval comes with a black box warning, the...

EMA(Europeans Medicines Agency) has updated the Appendix 1 Acceptable intakes established for N-nitrosamines with 15 more substances in February 2024. The new list cover drug molecules Cyanocobalamine, Apixaban, Clozapine, Tamoxifen, Flecainide, Masitinib, Telmisartan, Meropenem, Methylphenidate, Silodosin and Terazosin. The list...

USFDA has updated Safety Communication on Chinese made plastic syringes. FDA had issued a Safety Communication on plastic syringes made in China earlier in November 2023. FDA’s concerns on Chinese made plastic syringes include performance & safety of the syringes,...

USFDA had inspected Aurobindo’s Eugia SEZ Pvt Ltd facility at Polepally, Telengana in India in Feb 2024. This was the third Eugia facility (FEI 3011905047) to be inspected by FDA in a span of 3 months after the Eugia US...

USFDA has issued a new guidance for primary batches to be included in the CMC section in Animal Drug Applications. The guidance is applicable for New Animal Drug Applications (NADAs), Abbreviated New Animal Drug Applications (ANADAs) and associated applications like...